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出境医 / 临床实验 / Bilateral Erector Spinae Plane Block After Elective Cesarean Section

Bilateral Erector Spinae Plane Block After Elective Cesarean Section

Study Description
Brief Summary:
The aim of work is to assess and compare the analgesic efficacy of bilateral erector spinae plane block with that of bilateral transversus abdominis plane block after elective cesarean section.

Condition or disease Intervention/treatment Phase
Postoperative Pain Procedure: ESPB and TAP block Not Applicable

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Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Single-blind
Primary Purpose: Prevention
Official Title: Comparative Study Between the Analgesic Effect of Erector Spinae Plane Block and Transversus Abdominis Plane Block After Elective Cesarean Section
Actual Study Start Date : July 8, 2019
Actual Primary Completion Date : December 31, 2019
Actual Study Completion Date : January 1, 2020
Arms and Interventions
Arm Intervention/treatment
Active Comparator: ES Erector Spinae Plane Block

bilateral ESP block at the level of T9 by a linear ultrasound (US) transducer (Phillips Saronno Italy) placed vertically 3cm lateral to the midline to visualize the back muscles superior to the transverse process.

A 22-G short bevel needle (spinocan, B.Braun, melsungen AG, Germany) will be inserted in cranial-caudal direction until it make contact with the transverse process. Confirmation of the correct position of the tip of the needle is by injection of 1 ml saline causing hydrodisscetion between the erector spinae muscle and the transverse process. After careful aspiration to exclude vascular puncture, 20 ml 0.25 % bupivacaine is injected.The same procedure is done on the other side of the back.

Procedure: ESPB and TAP block

bilateral TAP block: while the patient in the supine position, a linear ultrasound (US) transducer (Phillips Saronno Italy) is placed transversally on the anterolateral abdominal wall in the midaxillary line between the iliac crest and the costal margin identifying external oblique, internal oblique and transversus abdominis muscles. The TAP is between internal oblique and transversus abdominis.

A 22-G needle (spinocan, B.Braun, melsungen AG, Germany) is introduced anteriorly to the transducer and advanced to reach the TAP between internal oblique muscle and transversus abdominis muscle. After careful aspiration to exclude vascular puncture, 20 ml 0.5 % bupivacaine is injected causing an elliptical separation of the two muscles. The same procedure is done on the other side.


Active Comparator: TAP Transversus Abdominis Plane Block

bilateral TAP block: while the patient in the supine position, a linear ultrasound (US) transducer (Phillips Saronno Italy) is placed transversally on the anterolateral abdominal wall in the midaxillary line between the iliac crest and the costal margin identifying external oblique, internal oblique and transversus abdominis muscles. The TAP is between internal oblique and transversus abdominis.

A 22-G needle (spinocan, B.Braun, melsungen AG, Germany) is introduced anteriorly to the transducer and advanced to reach the TAP between internal oblique muscle and transversus abdominis muscle. After careful aspiration to exclude vascular puncture, 20 ml 0.25 % bupivacaine is injected causing an elliptical separation of the two muscles. The same procedure is done on the other side.

Procedure: ESPB and TAP block

bilateral TAP block: while the patient in the supine position, a linear ultrasound (US) transducer (Phillips Saronno Italy) is placed transversally on the anterolateral abdominal wall in the midaxillary line between the iliac crest and the costal margin identifying external oblique, internal oblique and transversus abdominis muscles. The TAP is between internal oblique and transversus abdominis.

A 22-G needle (spinocan, B.Braun, melsungen AG, Germany) is introduced anteriorly to the transducer and advanced to reach the TAP between internal oblique muscle and transversus abdominis muscle. After careful aspiration to exclude vascular puncture, 20 ml 0.5 % bupivacaine is injected causing an elliptical separation of the two muscles. The same procedure is done on the other side.


Outcome Measures
Primary Outcome Measures :
  1. duration of analgesia of the two blocks [ Time Frame: 24 hours ]
    time


Secondary Outcome Measures :
  1. Visual analogue scale [ Time Frame: immediatiy in pacu ]
    Visual analogue scale for pain

  2. Visual analogue scale [ Time Frame: 4 hours ]
    Visual analogue scale for pain

  3. Visual analogue scale [ Time Frame: 8 hours ]
    Visual analogue scale for pain

  4. Visual analogue scale [ Time Frame: 12 hours ]
    Visual analogue scale for pain

  5. Visual analogue scale [ Time Frame: 24 hours ]
    Visual analogue scale for pain

  6. the first request to analgesia [ Time Frame: 24 hours ]
    duration

  7. total analgesic consumption [ Time Frame: 24 hours ]
    amount


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   18 years
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • aged 18 - 40 years
  • American Society of Anesthesiologists physical status ІІ, scheduled for elective cesarean section via a low transverse abdominal incision (Pfannenstiel) and receiving intrathecal anesthesia without sedation.

Exclusion Criteria:

  • Patient refusal.
  • Contraindications to regional anesthesia.
  • Known allergy to the study drugs.
  • Severe cardiovascular, renal or hepatic diseases.
  • Bleeding disorders.
  • Local infection.
Contacts and Locations

Locations
Layout table for location information
Egypt
Faculty of Medicine
Fayoum, Egypt, 63511
Mohamed Hamed
Fayoum, Egypt, 63511
Mohamed
Fayoum, Egypt, 65345
Sponsors and Collaborators
Fayoum University
Tracking Information
First Submitted Date  ICMJE July 8, 2019
First Posted Date  ICMJE July 11, 2019
Last Update Posted Date January 22, 2020
Actual Study Start Date  ICMJE July 8, 2019
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
duration of analgesia of the two blocks [ Time Frame: 24 hours ]
time
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2019)
  • Visual analogue scale [ Time Frame: immediatiy in pacu ]
    Visual analogue scale for pain
  • Visual analogue scale [ Time Frame: 4 hours ]
    Visual analogue scale for pain
  • Visual analogue scale [ Time Frame: 8 hours ]
    Visual analogue scale for pain
  • Visual analogue scale [ Time Frame: 12 hours ]
    Visual analogue scale for pain
  • Visual analogue scale [ Time Frame: 24 hours ]
    Visual analogue scale for pain
  • the first request to analgesia [ Time Frame: 24 hours ]
    duration
  • total analgesic consumption [ Time Frame: 24 hours ]
    amount
Original Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2019)
  • VAS [ Time Frame: immediatiy in pacu ]
    Visual analogue scale
  • VAS [ Time Frame: 4 hours ]
    Visual analogue scale
  • VAS [ Time Frame: 8 hours ]
    Visual analogue scale
  • VAS [ Time Frame: 12 hours ]
    Visual analogue scale
  • VAS [ Time Frame: 24 hours ]
    Visual analogue scale
  • the first request to analgesia [ Time Frame: 24 hours ]
    duration
  • total analgesic consumption [ Time Frame: 24 hours ]
    amount
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Bilateral Erector Spinae Plane Block After Elective Cesarean Section
Official Title  ICMJE Comparative Study Between the Analgesic Effect of Erector Spinae Plane Block and Transversus Abdominis Plane Block After Elective Cesarean Section
Brief Summary The aim of work is to assess and compare the analgesic efficacy of bilateral erector spinae plane block with that of bilateral transversus abdominis plane block after elective cesarean section.
Detailed Description

Inclusion criteria:

- Parturients aged 18 - 40 years with American Society of Anesthesiologists physical status І or ІІ, scheduled for elective cesarean section via a low transverse abdominal incision (Pfannenstiel) and receiving intrathecal anesthesia without sedation.

Exclusion criteria:

  • Patient refusal.
  • Contraindications to regional anesthesia.
  • Known allergy to the study drugs.
  • Severe cardiovascular, renal or hepatic diseases.
  • Bleeding disorders.
  • Local infection.

Participants will be randomly divided into two groups:

Group A will receive bilateral Erector spinae plane block. (n=30) Group B will receive bilateral Transversus abdominis plane block. (n=30) Simple randomization will be performed by computer-generated random numbers that will be placed in separate opaque envelopes that will be opened by responsible anesthesiologist just before the intrathecal block.

Routine preoperative investigations including electrocardiogram (ECG), complete blood picture, renal function tests, liver function tests, and coagulation profile will be done. All parturients will fast for 8 h preoperatively. IV access will be obtained (one peripheral venous cannula 18G) and standard monitoring including pulse oximetry, ECG and noninvasive blood pressure will be placed for measurement of the hemodynamic variability.

Ten ml.kg-1 of Ringer lactate solution will be infused over 15 minutes as a preload. The parturient will be asked to turn into sitting position where the skin on the back will be sterilized and spinal anesthesia will be performed via a midline approach into the L4-5 interspaces using a 25 gauge Quincke spinal needle after giving 3 ml of lidocaine 2% as a subcutaneous infiltration. After confirming free CSF flow through the needle, a 10mg of hyperbaric bupivacaine 0.5 % will be slowly injected for both groups.

The parturient will be placed in the supine position with 15° left tilt, and an oxygen mask will be applied at 2 L.min-1. The surgical procedure will start after sufficient anesthesia level is obtained, with continuous hemodynamics monitoring and recording.

After delivery of the fetus, 10 units of oxytocin will be given by IV infusion. By the end of the surgery, patients in group (A) received bilateral ESP block. First in the supine position, sham TAP block was done then the patient was turned into the lateral position to receive ESP block and after

proper skin sterilization then the vertebrae were counted from cephalad to caudal direction until T9 spinous process was reached as the first palpable spinous process is C7 and at this level a linear ultrasound (US) transducer (Phillips Saronno Italy) was placed vertically 3cm lateral to the midline to visualize the back muscles superior to the transverse process. -A 22-G short bevel needle (spinocan, B.Braun, melsungen AG, Germany) was inserted in cranial-caudal direction until it make contact with the transverse process. Confirmation of the correct position of the tip of the needle was by injection of 1 ml saline causing hydrodisscetion between the erector spinae muscle and the transverse process. After careful aspiration to exclude vascular puncture, 20 ml 0.25 % bupivacaine was injected. The same procedure was done on the other side of the back. -Patients in group (B) received bilateral TAP block. First in the supine position a linear ultrasound (US) transducer (Phillips Saronno Italy) was placed transversally on the anterolateral abdominal wall in the midaxillary line between the iliac crest and the costal margin identifying external oblique, internal oblique and transversus abdominis muscles. The TAP is between internal oblique and transversus abdominis. -A 22-G needle (spinocan, B.Braun, melsungen AG, Germany) was introduced anteriorly to the transducer and advanced to reach the TAP between internal oblique muscle and transversus abdominis muscle. After careful aspiration to exclude vascular puncture, 20 ml 0.25 % bupivacaine was injected causing an elliptical separation of the two muscles. The same procedure was done on the other side. Then the patient was placed in the lateral position to do sham ESP block.

The patients will be instructed to notify us if they have experienced any signs of systemic toxicity as circumoral or tongue numbness, dizziness, visual and auditory disturbances as difficulty focusing and tinnitus.

Spinal level will be assessed and recorded before both blocks in all patients, then they will be transferred to postoperative anesthesia care unit (PACU) with standard monitoring.

After surgery the patient will receive paracetamol 1gm IV infusion/8 hours, ketorolac 30 mg IV/12hours as a multimodal analgesia for postoperative pain.

Postoperative pain will be assessed by Visual analog scale (VAS) for pain (ranging from 0 to 10, where 0 no pain and 10 the worst possible pain) at time intervals at 0 hour, 4hours, 8 hours, 12hours and 24 hours. Postoperative mean arterial blood pressure and heart rate will be assessed and recorded.

Time for the first request to analgesia and total analgesic consumption will be recorded in the first 24 hours after surgery. Any complications as nausea and vomiting will be recorded.

Sensory block by a pin prick test will be assessed (0: normal sensation, 1: decreased pain sensation, 2: loss of pain sensation). The duration of the sensory block which is the time interval between performance of the block and complete resolution of anesthesia will be assessed and recorded every 2 hours.

Patient satisfaction with analgesia will be assessed as (0: poor, 1: good, 2: excellent).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
Single-blind
Primary Purpose: Prevention
Condition  ICMJE Postoperative Pain
Intervention  ICMJE Procedure: ESPB and TAP block

bilateral TAP block: while the patient in the supine position, a linear ultrasound (US) transducer (Phillips Saronno Italy) is placed transversally on the anterolateral abdominal wall in the midaxillary line between the iliac crest and the costal margin identifying external oblique, internal oblique and transversus abdominis muscles. The TAP is between internal oblique and transversus abdominis.

A 22-G needle (spinocan, B.Braun, melsungen AG, Germany) is introduced anteriorly to the transducer and advanced to reach the TAP between internal oblique muscle and transversus abdominis muscle. After careful aspiration to exclude vascular puncture, 20 ml 0.5 % bupivacaine is injected causing an elliptical separation of the two muscles. The same procedure is done on the other side.

Study Arms  ICMJE
  • Active Comparator: ES Erector Spinae Plane Block

    bilateral ESP block at the level of T9 by a linear ultrasound (US) transducer (Phillips Saronno Italy) placed vertically 3cm lateral to the midline to visualize the back muscles superior to the transverse process.

    A 22-G short bevel needle (spinocan, B.Braun, melsungen AG, Germany) will be inserted in cranial-caudal direction until it make contact with the transverse process. Confirmation of the correct position of the tip of the needle is by injection of 1 ml saline causing hydrodisscetion between the erector spinae muscle and the transverse process. After careful aspiration to exclude vascular puncture, 20 ml 0.25 % bupivacaine is injected.The same procedure is done on the other side of the back.

    Intervention: Procedure: ESPB and TAP block
  • Active Comparator: TAP Transversus Abdominis Plane Block

    bilateral TAP block: while the patient in the supine position, a linear ultrasound (US) transducer (Phillips Saronno Italy) is placed transversally on the anterolateral abdominal wall in the midaxillary line between the iliac crest and the costal margin identifying external oblique, internal oblique and transversus abdominis muscles. The TAP is between internal oblique and transversus abdominis.

    A 22-G needle (spinocan, B.Braun, melsungen AG, Germany) is introduced anteriorly to the transducer and advanced to reach the TAP between internal oblique muscle and transversus abdominis muscle. After careful aspiration to exclude vascular puncture, 20 ml 0.25 % bupivacaine is injected causing an elliptical separation of the two muscles. The same procedure is done on the other side.

    Intervention: Procedure: ESPB and TAP block
Publications *
  • Ueshima H, Otake H. Similarities Between the Retrolaminar and Erector Spinae Plane Blocks. Reg Anesth Pain Med. 2017 Jan/Feb;42(1):123-124. doi: 10.1097/AAP.0000000000000526.
  • Leung AY. Postoperative pain management in obstetric anesthesia--new challenges and solutions. J Clin Anesth. 2004 Feb;16(1):57-65. Review.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: July 9, 2019)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 1, 2020
Actual Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • aged 18 - 40 years
  • American Society of Anesthesiologists physical status ІІ, scheduled for elective cesarean section via a low transverse abdominal incision (Pfannenstiel) and receiving intrathecal anesthesia without sedation.

Exclusion Criteria:

  • Patient refusal.
  • Contraindications to regional anesthesia.
  • Known allergy to the study drugs.
  • Severe cardiovascular, renal or hepatic diseases.
  • Bleeding disorders.
  • Local infection.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: 18 years
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04016688
Other Study ID Numbers  ICMJE R 126
Has Data Monitoring Committee No
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 Mohamed Ahmed Hamed, Fayoum University
Study Sponsor  ICMJE Fayoum University
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Fayoum University
Verification Date January 2020

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