免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Acute Headache Treatment in Pregnancy: Occipital Nerve Block vs PO Acetaminophen With Caffeine

Acute Headache Treatment in Pregnancy: Occipital Nerve Block vs PO Acetaminophen With Caffeine

Study Description
Brief Summary:
This is an open label randomized controlled trial evaluating response to bupivacaine occipital nerve block compared to Tylenol/Caffeine cocktail in treatment of pregnant patients seeking care of headache.

Condition or disease Intervention/treatment Phase
Headache Pregnancy Related Occipital Nerve Block Drug: Occipital Nerve Block Phase 4

Detailed Description:

This is an open label randomized controlled trial. Women who present to the MEU with headache will be assessed by trained nurse practitioners and/or OB/GYN residents. If the woman meets criteria for the study she will be enrolled by an MEU provider doing the primary assessment.

See Figure 1 for the flow diagram depicting the patient's course through MEU. If eligible for inclusion, women will be randomly assigned to ONB or headache cocktail. Randomization will occur at time of enrollment. Prior to headache treatment 10-point visual/verbal rating scale (VRS) will be obtained. Treatment time is defined as time the patient takes the medication or the time that the needle is inserted into the greater occipital notch. At 60 min after treatment VRS will again be obtained by nursing staff or primary provider. If headache pain is resolved, defined as a VRS 0, the patient will be discharged to home (at the discretion of the managing team providing there are no other indications for further observation or admission). If pain continues to be present VRS will again be assessed at 120 min after treatment. If pain is not improved to mild range, defined as a VRS ≤ 3, or resolved, crossover treatment will be given. VRS will be obtained at 60 min after cross over treatment; if pain is resolved patient will be discharge to home. If pain continues to be present VRS will be obtained at 120 min after cross over treatment. If pain is not improved to mild pain or resolved; second line treatment of Promethazine 25mg/Benadryl 25mg will be given. VRS will again be obtained 60 min after second line treatment. If pain is not improved to mild pain (VRS ≤3) or resolved neurology consult will be considered. If at any point during treatment the patient develops new neurological symptoms study protocol will be stopped and neurology will be consulted.

Patients will be called 7 days after discharge to access short term outcomes (headache frequency since MEU visit, injection site complications, and satisfaction with treatment.) Patients will again be called at 28 days and a chart abstraction will be done to access for long term outcomes (recurrent presentation for headache to the MEU, maternal complications including preeclampsia, or fetal complications).

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled Trail
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Acute Headache Treatment in Pregnancy: Improvement in Pain Scores With Occipital Nerve Block vs PO Acetaminophen With Caffeine A Randomized Controlled Trial
Actual Study Start Date : February 10, 2020
Estimated Primary Completion Date : December 1, 2021
Estimated Study Completion Date : June 1, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Occipital Nerve block
  1. Trained OB/GYN providers will perform a physical exam to access location of occipital nerve injection based on palpation of bony landmarks.
  2. Site of injection will be cleaned with an alcohol swab.
  3. 5cc of 0.5% bupivacaine will be injected into both right and left occipital nerves using a 2.5 inch 25 gauge needle. The needle will be changed between injecting sites.
  4. After injection is completed sterile gauze will be held on injection sites for 2-3 min or until bleeding is resolved.
 Drug: Occipital Nerve Block
This is an open label randomized controlled trial evaluating response to bupivacaine occipital nerve block compared to Tylenol/Caffeine cocktail in treatment of pregnant patients seeking care of headache.
Other Name: Acetaminophen/Caffeine
Active Comparator: Oral Acetaminophen/Caffeine Group
Acetaminophen 650mg PO and Caffeine 100mg PO (both Level A treatments for acute headache)
 Drug: Occipital Nerve Block
This is an open label randomized controlled trial evaluating response to bupivacaine occipital nerve block compared to Tylenol/Caffeine cocktail in treatment of pregnant patients seeking care of headache.
Other Name: Acetaminophen/Caffeine
Outcome Measures
Primary Outcome Measures :
  1. Response to occipital nerve block in pregnancy [ Time Frame: 60-300 min ]
    Based on guidelines from the International Headache Society the primary outcome is the portion of women who experience resolution of headache or improvement of headache to mild range (VRS ≤ 3) at 2 hours following treatment with Occipital nerve block as compared to acetaminophen/caffeine cocktail.


Secondary Outcome Measures :
  1. Response to treatment within 2 hours [ Time Frame: 2 hrs ]
  2. Need for crossover treatment [ Time Frame: 4 hours ]
  3. Response to cross over treatment at 60 or 120 min [ Time Frame: 60-120 min ]
  4. Need for second line treatment [ Time Frame: 120 min ]
  5. Response to second line treatment at 60 min [ Time Frame: 180min ]
  6. Need for neurology consult [ Time Frame: 5 hours ]
  7. Need for admission for treatment of headache [ Time Frame: 7 hours ]
  8. Need for representation for treatment of headache with 28 days [ Time Frame: 28 days ]
  9. Development of hypertensive disease of pregnancy within 28 days [ Time Frame: 28 days ]
  10. Satisfaction with response treatment at 7 days [ Time Frame: 7 days ]
  11. Duration of headache free period at 7 days [ Time Frame: 7 days ]
  12. Development of hypertensive disease of pregnancy within 7 days [ Time Frame: 7 days ]
  13. Injection site complication (infection, hematoma, and ecchymosis) [ Time Frame: 7 days ]

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   16 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Pregnant Females
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  1. Women presenting to Maternal Evaluation Unit at UAB hospital
  2. Confirmed live intrauterine pregnancy (previous ultrasound, bedside ultrasound, fetal monitoring)
  3. Complaint of headache
  4. Minimal pain level of 4 on VRS

Exclusion criteria:

  1. Systolic BP >= 140 or diastolic BP>=90 with 1+ protein on urine dip
  2. Systolic BP >=160 or diastolic BP>=105
  3. Focal neurological symptoms
  4. Altered level of consciousness defined as not being oriented to person, place, situation, and/or year
  5. Complaint of seizure
  6. Known under lying brain abnormality
  7. Fever
  8. Use of >3 grams of acetaminophen in past 24hrs
  9. ONB in the past 3 months
  10. Reported allergy to study medications (Bupivacaine, acetaminophen, or caffeine)
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Elisa T Bushman, MD 205-934-9188 ebushman@uabmc.edu
Contact: Rachel G Sinkey, MD (205) 934-5612 rsinkey@uabmc.edu

Locations
Layout table for location information
United States, Alabama
The Women and Infants center at the University of Alabama Birmingham Recruiting
Birmingham, Alabama, United States, 35233
Contact: Elisa T Bushman, MD    205-934-9788    ebushman@uabmc.edu   
Contact: Rachael G Sinkey, MD    (205) 934-5612    rsinkey@uabmc.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
Tracking Information
First Submitted Date  ICMJE May 14, 2019
First Posted Date  ICMJE May 15, 2019
Last Update Posted Date May 27, 2021
Actual Study Start Date  ICMJE February 10, 2020
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019) 		Response to occipital nerve block in pregnancy [ Time Frame: 60-300 min ]
Based on guidelines from the International Headache Society the primary outcome is the portion of women who experience resolution of headache or improvement of headache to mild range (VRS ≤ 3) at 2 hours following treatment with Occipital nerve block as compared to acetaminophen/caffeine cocktail.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 11, 2020)
  • Response to treatment within 2 hours [ Time Frame: 2 hrs ]
  • Need for crossover treatment [ Time Frame: 4 hours ]
  • Response to cross over treatment at 60 or 120 min [ Time Frame: 60-120 min ]
  • Need for second line treatment [ Time Frame: 120 min ]
  • Response to second line treatment at 60 min [ Time Frame: 180min ]
  • Need for neurology consult [ Time Frame: 5 hours ]
  • Need for admission for treatment of headache [ Time Frame: 7 hours ]
  • Need for representation for treatment of headache with 28 days [ Time Frame: 28 days ]
  • Development of hypertensive disease of pregnancy within 28 days [ Time Frame: 28 days ]
  • Satisfaction with response treatment at 7 days [ Time Frame: 7 days ]
  • Duration of headache free period at 7 days [ Time Frame: 7 days ]
  • Development of hypertensive disease of pregnancy within 7 days [ Time Frame: 7 days ]
  • Injection site complication (infection, hematoma, and ecchymosis) [ Time Frame: 7 days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
  • Response to treatment within 2 hours [ Time Frame: 2 hrs ]
  • Need for crossover treatment [ Time Frame: 4 hours ]
  • Response to cross over treatment at 60 or 120 min [ Time Frame: 60-120 min ]
  • Need for second line treatment [ Time Frame: 120 min ]
  • Response to second line treatment at 60 min [ Time Frame: 180min ]
  • Need for neurology consult [ Time Frame: 5 hours ]
  • Need for admission for treatment of headache [ Time Frame: 7 hours ]
  • Need for representation for treatment of headache with 28 days [ Time Frame: 28 days ]
  • Development of hypertensive disease of pregnancy within 28 days [ Time Frame: 28 days ]
  • Satisfaction with treatment at 7 days [ Time Frame: 7 days ]
  • Duration of headache free period at 7 days [ Time Frame: 7 days ]
  • Development of hypertensive disease of pregnancy within 7 days [ Time Frame: 7 days ]
  • Injection site complication (infection, hematoma, and ecchymosis) [ Time Frame: 7 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acute Headache Treatment in Pregnancy: Occipital Nerve Block vs PO Acetaminophen With Caffeine
Official Title  ICMJE Acute Headache Treatment in Pregnancy: Improvement in Pain Scores With Occipital Nerve Block vs PO Acetaminophen With Caffeine A Randomized Controlled Trial
Brief Summary This is an open label randomized controlled trial evaluating response to bupivacaine occipital nerve block compared to Tylenol/Caffeine cocktail in treatment of pregnant patients seeking care of headache.
Detailed Description

This is an open label randomized controlled trial. Women who present to the MEU with headache will be assessed by trained nurse practitioners and/or OB/GYN residents. If the woman meets criteria for the study she will be enrolled by an MEU provider doing the primary assessment.

See Figure 1 for the flow diagram depicting the patient's course through MEU. If eligible for inclusion, women will be randomly assigned to ONB or headache cocktail. Randomization will occur at time of enrollment. Prior to headache treatment 10-point visual/verbal rating scale (VRS) will be obtained. Treatment time is defined as time the patient takes the medication or the time that the needle is inserted into the greater occipital notch. At 60 min after treatment VRS will again be obtained by nursing staff or primary provider. If headache pain is resolved, defined as a VRS 0, the patient will be discharged to home (at the discretion of the managing team providing there are no other indications for further observation or admission). If pain continues to be present VRS will again be assessed at 120 min after treatment. If pain is not improved to mild range, defined as a VRS ≤ 3, or resolved, crossover treatment will be given. VRS will be obtained at 60 min after cross over treatment; if pain is resolved patient will be discharge to home. If pain continues to be present VRS will be obtained at 120 min after cross over treatment. If pain is not improved to mild pain or resolved; second line treatment of Promethazine 25mg/Benadryl 25mg will be given. VRS will again be obtained 60 min after second line treatment. If pain is not improved to mild pain (VRS ≤3) or resolved neurology consult will be considered. If at any point during treatment the patient develops new neurological symptoms study protocol will be stopped and neurology will be consulted.

Patients will be called 7 days after discharge to access short term outcomes (headache frequency since MEU visit, injection site complications, and satisfaction with treatment.) Patients will again be called at 28 days and a chart abstraction will be done to access for long term outcomes (recurrent presentation for headache to the MEU, maternal complications including preeclampsia, or fetal complications).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized controlled Trail
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Headache
  • Pregnancy Related
  • Occipital Nerve Block
Intervention  ICMJE Drug: Occipital Nerve Block
This is an open label randomized controlled trial evaluating response to bupivacaine occipital nerve block compared to Tylenol/Caffeine cocktail in treatment of pregnant patients seeking care of headache.
Other Name: Acetaminophen/Caffeine
Study Arms  ICMJE
  • Experimental: Occipital Nerve block
    1. Trained OB/GYN providers will perform a physical exam to access location of occipital nerve injection based on palpation of bony landmarks.
    2. Site of injection will be cleaned with an alcohol swab.
    3. 5cc of 0.5% bupivacaine will be injected into both right and left occipital nerves using a 2.5 inch 25 gauge needle. The needle will be changed between injecting sites.
    4. After injection is completed sterile gauze will be held on injection sites for 2-3 min or until bleeding is resolved.
    Intervention: Drug: Occipital Nerve Block
  • Active Comparator: Oral Acetaminophen/Caffeine Group
    Acetaminophen 650mg PO and Caffeine 100mg PO (both Level A treatments for acute headache)
    Intervention: Drug: Occipital Nerve Block
Publications *
  • Rasmussen BK, Jensen R, Schroll M, Olesen J. Epidemiology of headache in a general population--a prevalence study. J Clin Epidemiol. 1991;44(11):1147-57.
  • Lipton RB, Bigal ME, Diamond M, Freitag F, Reed ML, Stewart WF; AMPP Advisory Group. Migraine prevalence, disease burden, and the need for preventive therapy. Neurology. 2007 Jan 30;68(5):343-9.
  • Scharff L, Marcus DA, Turk DC. Headache during pregnancy and in the postpartum: a prospective study. Headache. 1997 Apr;37(4):203-10.
  • Bushman ET, Varner MW, Digre KB. Headaches Through a Woman's Life. Obstet Gynecol Surv. 2018 Mar;73(3):161-173. doi: 10.1097/OGX.0000000000000540. Review.
  • Robbins MS, Farmakidis C, Dayal AK, Lipton RB. Acute headache diagnosis in pregnant women: a hospital-based study. Neurology. 2015 Sep 22;85(12):1024-30. doi: 10.1212/WNL.0000000000001954. Epub 2015 Aug 19.
  • Loder E, Biondi D. General principles of migraine management: the changing role of prevention. Headache. 2005 Apr;45 Suppl 1:S33-47. Review.
  • Cuadrado ML, Aledo-Serrano Á, Navarro P, López-Ruiz P, Fernández-de-Las-Peñas C, González-Suárez I, Orviz A, Fernández-Pérez C. Short-term effects of greater occipital nerve blocks in chronic migraine: A double-blind, randomised, placebo-controlled clinical trial. Cephalalgia. 2017 Aug;37(9):864-872. doi: 10.1177/0333102416655159. Epub 2016 Jun 12.
  • Dach F, Éckeli ÁL, Ferreira Kdos S, Speciali JG. Nerve block for the treatment of headaches and cranial neuralgias - a practical approach. Headache. 2015 Feb;55 Suppl 1:59-71. doi: 10.1111/head.12516. Epub 2015 Feb 3. Review.
  • Gul HL, Ozon AO, Karadas O, Koc G, Inan LE. The efficacy of greater occipital nerve blockade in chronic migraine: A placebo-controlled study. Acta Neurol Scand. 2017 Aug;136(2):138-144. doi: 10.1111/ane.12716. Epub 2016 Dec 2.
  • Hascalovici JR, Robbins MS. Peripheral Nerve Blocks for the Treatment of Headache in Older Adults: A Retrospective Study. Headache. 2017 Jan;57(1):80-86. doi: 10.1111/head.12992. Epub 2016 Nov 30.
  • Tang Y, Kang J, Zhang Y, Zhang X. Influence of greater occipital nerve block on pain severity in migraine patients: A systematic review and meta-analysis. Am J Emerg Med. 2017 Nov;35(11):1750-1754. doi: 10.1016/j.ajem.2017.08.027. Epub 2017 Aug 14. Review.
  • Tobin J, Flitman S. Occipital nerve blocks: when and what to inject? Headache. 2009 Nov-Dec;49(10):1521-33. doi: 10.1111/j.1526-4610.2009.01493.x. Epub 2009 Aug 6. Review.
  • Blumenfeld A, Ashkenazi A, Napchan U, Bender SD, Klein BC, Berliner R, Ailani J, Schim J, Friedman DI, Charleston L 4th, Young WB, Robertson CE, Dodick DW, Silberstein SD, Robbins MS. Expert consensus recommendations for the performance of peripheral nerve blocks for headaches--a narrative review. Headache. 2013 Mar;53(3):437-46. doi: 10.1111/head.12053. Epub 2013 Feb 13. Review.
  • Voigt CL, Murphy MO. Occipital nerve blocks in the treatment of headaches: safety and efficacy. J Emerg Med. 2015 Jan;48(1):115-29. doi: 10.1016/j.jemermed.2014.09.007. Epub 2014 Oct 18. Review.
  • Govindappagari S, Grossman TB, Dayal AK, Grosberg BM, Vollbracht S, Robbins MS. Peripheral nerve blocks in the treatment of migraine in pregnancy. Obstet Gynecol. 2014 Dec;124(6):1169-1174. doi: 10.1097/AOG.0000000000000555.
  • Lipton RB, Baggish JS, Stewart WF, Codispoti JR, Fu M. Efficacy and safety of acetaminophen in the treatment of migraine: results of a randomized, double-blind, placebo-controlled, population-based study. Arch Intern Med. 2000 Dec 11-25;160(22):3486-92.
  • Marmura MJ, Silberstein SD, Schwedt TJ. The acute treatment of migraine in adults: the american headache society evidence assessment of migraine pharmacotherapies. Headache. 2015 Jan;55(1):3-20. doi: 10.1111/head.12499. Review.
  • James AH, Brancazio LR, Price T. Aspirin and reproductive outcomes. Obstet Gynecol Surv. 2008 Jan;63(1):49-57. Review.
  • Korucu O, Dagar S, Çorbacioglu ŞK, Emektar E, Cevik Y. The effectiveness of greater occipital nerve blockade in treating acute migraine-related headaches in emergency departments. Acta Neurol Scand. 2018 Sep;138(3):212-218. doi: 10.1111/ane.12952. Epub 2018 May 10.
  • Allen SM, Mookadam F, Cha SS, Freeman JA, Starling AJ, Mookadam M. Greater Occipital Nerve Block for Acute Treatment of Migraine Headache: A Large Retrospective Cohort Study. J Am Board Fam Med. 2018 Mar-Apr;31(2):211-218. doi: 10.3122/jabfm.2018.02.170188.
  • Negro A, Delaruelle Z, Ivanova TA, Khan S, Ornello R, Raffaelli B, Terrin A, Reuter U, Mitsikostas DD; European Headache Federation School of Advanced Studies (EHF-SAS). Headache and pregnancy: a systematic review. J Headache Pain. 2017 Oct 19;18(1):106. doi: 10.1186/s10194-017-0816-0. Review.
  • Schoen JC, Campbell RL, Sadosty AT. Headache in pregnancy: an approach to emergency department evaluation and management. West J Emerg Med. 2015 Mar;16(2):291-301. doi: 10.5811/westjem.2015.1.23688. Epub 2015 Feb 25. Review.
  • Lipton RB, Diener HC, Robbins MS, Garas SY, Patel K. Caffeine in the management of patients with headache. J Headache Pain. 2017 Oct 24;18(1):107. doi: 10.1186/s10194-017-0806-2. Review.
  • Diener HC, Tassorelli C, Dodick DW, Silberstein SD, Lipton RB, Ashina M, Becker WJ, Ferrari MD, Goadsby PJ, Pozo-Rosich P, Wang SJ, Mandrekar J; International Headache Society Clinical Trials Standing Committee. Guidelines of the International Headache Society for controlled trials of acute treatment of migraine attacks in adults: Fourth edition. Cephalalgia. 2019 May;39(6):687-710. doi: 10.1177/0333102419828967. Epub 2019 Feb 26.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 14, 2019) 		62
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 1, 2022
Estimated Primary Completion Date December 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. Women presenting to Maternal Evaluation Unit at UAB hospital
  2. Confirmed live intrauterine pregnancy (previous ultrasound, bedside ultrasound, fetal monitoring)
  3. Complaint of headache
  4. Minimal pain level of 4 on VRS

Exclusion criteria:

  1. Systolic BP >= 140 or diastolic BP>=90 with 1+ protein on urine dip
  2. Systolic BP >=160 or diastolic BP>=105
  3. Focal neurological symptoms
  4. Altered level of consciousness defined as not being oriented to person, place, situation, and/or year
  5. Complaint of seizure
  6. Known under lying brain abnormality
  7. Fever
  8. Use of >3 grams of acetaminophen in past 24hrs
  9. ONB in the past 3 months
  10. Reported allergy to study medications (Bupivacaine, acetaminophen, or caffeine)
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Pregnant Females
Ages  ICMJE 16 Years to 60 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Elisa T Bushman, MD 205-934-9188 ebushman@uabmc.edu
Contact: Rachel G Sinkey, MD (205) 934-5612 rsinkey@uabmc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03951649
Other Study ID Numbers  ICMJE HA123456789
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Elisa T Bushman, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Alabama at Birmingham
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

前沿医讯