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出境医 / 临床实验 / Quadratus Lumborum Block Versus Fascia Iliaca Block for Hip Arthroplasty

Quadratus Lumborum Block Versus Fascia Iliaca Block for Hip Arthroplasty

Study Description
Brief Summary:

Quadratus lumborum block is a newly developed block with good performance in lower abdominal surgery. In a cadaveric study, the spread of local anesthetic in the anterior approach of QL block (QL3) was reported to cover nerve roots from T10 to L3. Thus, it was hypothesized that this approach could be used in hip surgeries with minimal motor affection.

This study aims to compare QL3 block and suprainguinal Fascia Iliaca block in the duration of postoperative analgesia, pain scores, motor power in quadriceps muscle, and side effects.


Condition or disease Intervention/treatment Phase
Post Operative Pain Procedure: quadratus lumborum block; (Anterior QLB or QLB III) Procedure: suprainguinal fascia iliaca block Procedure: Subarachnoid block Not Applicable

Detailed Description:

A randomized, controlled, double blinded, trial will be conducted in Cairo university hospital. Written informed consent will be obtained from all participants. Randomization will be achieved using a computer-generated sequence. Concealment will be achieved using opaque envelopes. Patients scheduled for hip replacement surgeries under subarachnoid block (SAB). e.g. hip hemiarthroplasty, total hip arthroplasty.

On arrival of the patients to regional anesthesia room, patients will be secured with 18-gauge intravenous cannula, and will receive ondansetron (4 mg), and dexamethasone (8 mg IV). Monitoring will include Electrocardiography, non-invasive arterial blood pressure, and pulse oximetry.

Before receiving subarachinoid block, patients will be randomly assigned into one of the two study groups:

QLB Group (n=17): this group will receive ultrasound-guided transmuscular quadratus lumborum block; (Anterior QLB or QLB III) FIB Group (n=17): this group will receive suprainguinal fascia iliaca block To achieve double blinding, patients will receive the block with 30 mL bupivacaine (0.25%) by the anesthetist. Another doctor not involved in the block procedure will evaluate the patients postoperative.

After finishing the block & assessment of motor power of quadriceps femoris muscle , patient will receive midazolam (2mg intravenous), and then transferred to operation room.

Postoperatively, all patients will receive 1 g paracetamol every 6 hours and 30 mg ketorolac every 12 hours.

If the visual analogue scale (VAS) is 4 or more, a 2 mg morphine increment will be added per time to maintain a resting VAS at <3 with maximum total 24-hours morphine 10 mg.

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Quadratus Lumborum Block Versus Fascia Iliaca Block for Hip Arthroplasty: A Randomized Controlled Trial
Actual Study Start Date : July 5, 2019
Estimated Primary Completion Date : October 5, 2019
Estimated Study Completion Date : October 15, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: QLB Group
this group will receive ultrasound-guided transmuscular quadratus lumborum block; (Anterior QLB or QLB III)
Procedure: quadratus lumborum block; (Anterior QLB or QLB III)
The patient will be in the lateral position. A low frequency convex probe will be vertically attached above the iliac crest and a needle will be inserted in plane from the posterior edge of the convex probe through the quadratus lumborum in an anteromedial direction. The needle tip will be placed between the psoas major muscle and the quadratus lumborum muscle. After negative aspiration, 30 mL of 0.25 % of bupivacaine will be injected into the fascial plane incrementally, aspirating every 5 ml.

Procedure: Subarachnoid block

Patients will receive SAB using 25g spinal needle in the lateral position. Fifteen milligrams of hyperbaric bupivacaine will be administered at L3-L4 or at L4-L5 interspace in addition to 25 mcg fentanyl with rapid crystalloid co-load.

Spinal anesthesia will be considered successful when a bilateral block to T12, as assessed by loss of cold (cold ice) and pain (a 23-gauge needle) sensations, will be established 10 -minutes after the intrathecal injection. If spinal anesthesia failed, such patients will be administered general anesthesia and will be excluded from this study.

Other Name: spinal anesthesia

Experimental: FIB Group
this group will receive suprainguinal fascia iliaca block
Procedure: suprainguinal fascia iliaca block
In supine position, a high frequency linear probe will be placed in the inguinal crease. Scan starting laterally from the femoral artery and nerve in inguinal crease to identify the sartorius muscle, tracing the muscle until it's origin to anterior superior iliac spine. The shadow of the bony of iliac crest & iliacus muscle will be seen, the end point of the injection is deep to the fascia iliaca and above the iliacus muscle in the lateral part of the iliacus muscle. After negative aspiration, 30 mL of 0.25 % of bupivacaine will be injected under the fascial plane incrementally, aspirating every 5 ml.

Procedure: Subarachnoid block

Patients will receive SAB using 25g spinal needle in the lateral position. Fifteen milligrams of hyperbaric bupivacaine will be administered at L3-L4 or at L4-L5 interspace in addition to 25 mcg fentanyl with rapid crystalloid co-load.

Spinal anesthesia will be considered successful when a bilateral block to T12, as assessed by loss of cold (cold ice) and pain (a 23-gauge needle) sensations, will be established 10 -minutes after the intrathecal injection. If spinal anesthesia failed, such patients will be administered general anesthesia and will be excluded from this study.

Other Name: spinal anesthesia

Outcome Measures
Primary Outcome Measures :
  1. Duration of analgesia [ Time Frame: 24 hours postoperative ]
    If the visual analogue scale (VAS) is 4 or more, a 2 mg morphine increment will be added per time to maintain a resting VAS at <3 with maximum total 24-hours morphine 10 mg.


Secondary Outcome Measures :
  1. Static visual analogue pain scale [ Time Frame: 24 hours postoperative ]
    Visual analogue pain scale (VAS) at rest. The pain visual analogue pain scale( VAS) is a continuous scale 10 centimeters (100 mm) in length. The scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]).

  2. Dynamic visual analogue pain scale [ Time Frame: 24 hours postoperative ]
    Visual analogue pain scale (VAS) on movement. The pain visual analogue pain scale( VAS) is a continuous scale 10 centimeters (100 mm) in length. The scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]).

  3. Onset of sensory block of quadratus lumborum block and fascia iliaca block [ Time Frame: 30 minutes ]
    the time interval between the injection of the study medication till complete loss of sensation

  4. Time to first postoperative analgesic request [ Time Frame: 24 hours postoperative ]
    morphine increment will be added per time to maintain a resting VAS at <3 with maximum

  5. Total morphine requirements [ Time Frame: 24 hours postoperative ]
    If the visual analogue scale (VAS) is 4 or more, a 2 mg morphine increment will be added per time to maintain a resting VAS at <3 with maximum total 24-hours morphine 10 mg.

  6. Assessment of the quadriceps muscle power. [ Time Frame: 24 hours ]
    the patient will be in supine position and the patient's knee will be fully flexed, and the patient will be asked to extend it. The motor block is classified as follows: grade 0; normal muscle power, grade I; motor weakness, grade II; complete motor paralysis

  7. Time needed to perform the block [ Time Frame: 30 minutes ]
    the total time of the procedure (quadratus lumborum block or fascia iliaca block) started from patient positioning till completion of local anesthesia injection.

  8. incidence of pain during positioning for spinal block [ Time Frame: 30 minutes ]
    to assess the ability of either two types of the the blocks to relieve pain during positioning for spinal anesthesia


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients scheduled for hip replacement surgeries under subarachnoid block (SAB). e.g. hip hemiarthroplasty, total hip arthroplasty.

Exclusion Criteria:

  • Coagulopathy, infection at the injection site,.
  • Allergy to local anesthetics.
  • Severe cardiopulmonary disease (≥ASA IV),.
  • Diabetic or other neuropathies.
  • Patients receiving opioids for chronic analgesic therapy.
  • Contraindication to spinal anesthesia.
  • Inability to comprehend visual analogue scale (VAS).
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Ahmed M. Hasanin, M.D. +201095076954 ahmedmohamedhasanin@gmail.com
Contact: Mahmoud swilem +201008855731 mr.sewilam@gmail.com

Locations
Layout table for location information
Egypt
Anesthesia Department Recruiting
Cairo, Egypt, 1772
Contact: Bassant abdelhamid, M.D.    01224254012    bassantmohamed197@yahoo.com   
Principal Investigator: Ahmed Hassanin, M.D.         
Sub-Investigator: Mahmoud Swilem         
Sponsors and Collaborators
Bassant M. Abdelhamid
Investigators
Layout table for investigator information
Principal Investigator: Ahmed M. Hasanin, M.D. Cairo University
Tracking Information
First Submitted Date  ICMJE June 26, 2019
First Posted Date  ICMJE July 2, 2019
Last Update Posted Date July 8, 2019
Actual Study Start Date  ICMJE July 5, 2019
Estimated Primary Completion Date October 5, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2019)
Duration of analgesia [ Time Frame: 24 hours postoperative ]
If the visual analogue scale (VAS) is 4 or more, a 2 mg morphine increment will be added per time to maintain a resting VAS at <3 with maximum total 24-hours morphine 10 mg.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2019)
  • Static visual analogue pain scale [ Time Frame: 24 hours postoperative ]
    Visual analogue pain scale (VAS) at rest. The pain visual analogue pain scale( VAS) is a continuous scale 10 centimeters (100 mm) in length. The scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]).
  • Dynamic visual analogue pain scale [ Time Frame: 24 hours postoperative ]
    Visual analogue pain scale (VAS) on movement. The pain visual analogue pain scale( VAS) is a continuous scale 10 centimeters (100 mm) in length. The scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale]).
  • Onset of sensory block of quadratus lumborum block and fascia iliaca block [ Time Frame: 30 minutes ]
    the time interval between the injection of the study medication till complete loss of sensation
  • Time to first postoperative analgesic request [ Time Frame: 24 hours postoperative ]
    morphine increment will be added per time to maintain a resting VAS at <3 with maximum
  • Total morphine requirements [ Time Frame: 24 hours postoperative ]
    If the visual analogue scale (VAS) is 4 or more, a 2 mg morphine increment will be added per time to maintain a resting VAS at <3 with maximum total 24-hours morphine 10 mg.
  • Assessment of the quadriceps muscle power. [ Time Frame: 24 hours ]
    the patient will be in supine position and the patient's knee will be fully flexed, and the patient will be asked to extend it. The motor block is classified as follows: grade 0; normal muscle power, grade I; motor weakness, grade II; complete motor paralysis
  • Time needed to perform the block [ Time Frame: 30 minutes ]
    the total time of the procedure (quadratus lumborum block or fascia iliaca block) started from patient positioning till completion of local anesthesia injection.
  • incidence of pain during positioning for spinal block [ Time Frame: 30 minutes ]
    to assess the ability of either two types of the the blocks to relieve pain during positioning for spinal anesthesia
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Quadratus Lumborum Block Versus Fascia Iliaca Block for Hip Arthroplasty
Official Title  ICMJE Quadratus Lumborum Block Versus Fascia Iliaca Block for Hip Arthroplasty: A Randomized Controlled Trial
Brief Summary

Quadratus lumborum block is a newly developed block with good performance in lower abdominal surgery. In a cadaveric study, the spread of local anesthetic in the anterior approach of QL block (QL3) was reported to cover nerve roots from T10 to L3. Thus, it was hypothesized that this approach could be used in hip surgeries with minimal motor affection.

This study aims to compare QL3 block and suprainguinal Fascia Iliaca block in the duration of postoperative analgesia, pain scores, motor power in quadriceps muscle, and side effects.

Detailed Description

A randomized, controlled, double blinded, trial will be conducted in Cairo university hospital. Written informed consent will be obtained from all participants. Randomization will be achieved using a computer-generated sequence. Concealment will be achieved using opaque envelopes. Patients scheduled for hip replacement surgeries under subarachnoid block (SAB). e.g. hip hemiarthroplasty, total hip arthroplasty.

On arrival of the patients to regional anesthesia room, patients will be secured with 18-gauge intravenous cannula, and will receive ondansetron (4 mg), and dexamethasone (8 mg IV). Monitoring will include Electrocardiography, non-invasive arterial blood pressure, and pulse oximetry.

Before receiving subarachinoid block, patients will be randomly assigned into one of the two study groups:

QLB Group (n=17): this group will receive ultrasound-guided transmuscular quadratus lumborum block; (Anterior QLB or QLB III) FIB Group (n=17): this group will receive suprainguinal fascia iliaca block To achieve double blinding, patients will receive the block with 30 mL bupivacaine (0.25%) by the anesthetist. Another doctor not involved in the block procedure will evaluate the patients postoperative.

After finishing the block & assessment of motor power of quadriceps femoris muscle , patient will receive midazolam (2mg intravenous), and then transferred to operation room.

Postoperatively, all patients will receive 1 g paracetamol every 6 hours and 30 mg ketorolac every 12 hours.

If the visual analogue scale (VAS) is 4 or more, a 2 mg morphine increment will be added per time to maintain a resting VAS at <3 with maximum total 24-hours morphine 10 mg.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Post Operative Pain
Intervention  ICMJE
  • Procedure: quadratus lumborum block; (Anterior QLB or QLB III)
    The patient will be in the lateral position. A low frequency convex probe will be vertically attached above the iliac crest and a needle will be inserted in plane from the posterior edge of the convex probe through the quadratus lumborum in an anteromedial direction. The needle tip will be placed between the psoas major muscle and the quadratus lumborum muscle. After negative aspiration, 30 mL of 0.25 % of bupivacaine will be injected into the fascial plane incrementally, aspirating every 5 ml.
  • Procedure: suprainguinal fascia iliaca block
    In supine position, a high frequency linear probe will be placed in the inguinal crease. Scan starting laterally from the femoral artery and nerve in inguinal crease to identify the sartorius muscle, tracing the muscle until it's origin to anterior superior iliac spine. The shadow of the bony of iliac crest & iliacus muscle will be seen, the end point of the injection is deep to the fascia iliaca and above the iliacus muscle in the lateral part of the iliacus muscle. After negative aspiration, 30 mL of 0.25 % of bupivacaine will be injected under the fascial plane incrementally, aspirating every 5 ml.
  • Procedure: Subarachnoid block

    Patients will receive SAB using 25g spinal needle in the lateral position. Fifteen milligrams of hyperbaric bupivacaine will be administered at L3-L4 or at L4-L5 interspace in addition to 25 mcg fentanyl with rapid crystalloid co-load.

    Spinal anesthesia will be considered successful when a bilateral block to T12, as assessed by loss of cold (cold ice) and pain (a 23-gauge needle) sensations, will be established 10 -minutes after the intrathecal injection. If spinal anesthesia failed, such patients will be administered general anesthesia and will be excluded from this study.

    Other Name: spinal anesthesia
Study Arms  ICMJE
  • Experimental: QLB Group
    this group will receive ultrasound-guided transmuscular quadratus lumborum block; (Anterior QLB or QLB III)
    Interventions:
    • Procedure: quadratus lumborum block; (Anterior QLB or QLB III)
    • Procedure: Subarachnoid block
  • Experimental: FIB Group
    this group will receive suprainguinal fascia iliaca block
    Interventions:
    • Procedure: suprainguinal fascia iliaca block
    • Procedure: Subarachnoid block
Publications *
  • Bullock WM, Yalamuri SM, Gregory SH, Auyong DB, Grant SA. Ultrasound-Guided Suprainguinal Fascia Iliaca Technique Provides Benefit as an Analgesic Adjunct for Patients Undergoing Total Hip Arthroplasty. J Ultrasound Med. 2017 Feb;36(2):433-438. doi: 10.7863/ultra.16.03012. Epub 2016 Dec 10.
  • Kadam VR. Ultrasound-guided quadratus lumborum block as a postoperative analgesic technique for laparotomy. J Anaesthesiol Clin Pharmacol. 2013 Oct;29(4):550-2. doi: 10.4103/0970-9185.119148.
  • Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3. Review.
  • Bang S, Chung J, Jeong J, Bak H, Kim D. Efficacy of ultrasound-guided fascia iliaca compartment block after hip hemiarthroplasty: A prospective, randomized trial. Medicine (Baltimore). 2016 Sep;95(39):e5018. doi: 10.1097/MD.0000000000005018.
  • Nassar H, Hasanin A, Sewilam M, Ahmed H, Abo-Elsoud M, Taalab O, Rady A, Zoheir HA. Transmuscular Quadratus Lumborum Block versus Suprainguinal Fascia Iliaca Block for Hip Arthroplasty: A Randomized, Controlled Pilot Study. Local Reg Anesth. 2021 Apr 20;14:67-74. doi: 10.2147/LRA.S308964. eCollection 2021.

*   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: June 28, 2019)
34
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 15, 2019
Estimated Primary Completion Date October 5, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients scheduled for hip replacement surgeries under subarachnoid block (SAB). e.g. hip hemiarthroplasty, total hip arthroplasty.

Exclusion Criteria:

  • Coagulopathy, infection at the injection site,.
  • Allergy to local anesthetics.
  • Severe cardiopulmonary disease (≥ASA IV),.
  • Diabetic or other neuropathies.
  • Patients receiving opioids for chronic analgesic therapy.
  • Contraindication to spinal anesthesia.
  • Inability to comprehend visual analogue scale (VAS).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ahmed M. Hasanin, M.D. +201095076954 ahmedmohamedhasanin@gmail.com
Contact: Mahmoud swilem +201008855731 mr.sewilam@gmail.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04005326
Other Study ID Numbers  ICMJE N-144-2018
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Bassant M. Abdelhamid, Cairo University
Study Sponsor  ICMJE Bassant M. Abdelhamid
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ahmed M. Hasanin, M.D. Cairo University
PRS Account Cairo University
Verification Date July 2019

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