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Transversus Abdominis Plane Block for Post-operative Analgesia Following Cesarean Section

Primary Purpose

Analgesia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
TAPB
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia focused on measuring post-operative analgesia, Transversus Abdominis Plane Block

Eligibility Criteria

21 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA physical status I and ∏
  • primigravidas
  • aged 21-40 years
  • BMI ˂ 40
  • body weight ˃ 60 kg
  • singleton pregnancy
  • gestational age of ≥37 weeks
  • undergoing elective caesarean section under spinal anesthesia.

Exclusion Criteria:

  • Parturient refusal
  • parturient with a BMI > 40
  • body weight < 60 kg
  • ASA physical status ≥ III
  • known local anesthetic (LA) allergy •contraindications to spinal anesthesia
  • parturients who received analgesics in the past 24 hours
  • infection at the site of the block.

Sites / Locations

  • Ain-Shams University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Group MS

Group US

Arm Description

The modified surgeon assisted approach for TAPB Before the closure of the peritoneum, TAPB will be performed; at the level of the umbilicus 8 to 10cms from the midline bilaterally. A sterile 100-mm 22-G insulated needle will be inserted perpendicular to the skin slightly directed towards the ipsilateral anterior superior iliac spine. After feeling the 2 pops of the external and the internal oblique aponeurosis by the anesthesiologist, the surgeon will confirm proper needle placement by his hand inside the abdominal cavity. The LA will be injected after negative aspiration and a bleb will be palpated by the surgeon as the injection continues. The same procedure will be repeated on the other side.

The ultra-sound guided approach for TAPB. After abdominal wall closure, the linear probe of the ultra- sound will be placed perpendicular to the skin at the mid-axillary line between the iliac crest and the costal margin; the TAP will be located between the internal oblique and the transversus abdominis muscle. A sterile 100-mm 22-G insulated needle will be inserted perpendicular to the skin and the 2 pops of the external and the internal oblique aponeurosis will be also felt. The LA will be injected after negative aspiration and its spread in the plane will be observed. The same procedure will be repeated on the other side.

Outcomes

Primary Outcome Measures

Time to rescue analgesia
the time from the end of surgery until the first parturient's request for analgesia

Secondary Outcome Measures

Efficacy of the modified surgeon assisted approach for TAPB on postoperative analgesia
assessment of pain intensity at rest and on passive flexion of the hip and knee by the Numeric Pain Rating Score (NPRS) from 0 = no pain to 10 = worst pain. Assessment will be done at 2, 6, 12 and 24h postoperative.
Number of parturients requiring postoperative analgesia
defined as pethidine needed by each parturient in the 24 hours postoperative period
Total dose of pethidine given
defined as pethidine needed by each parturient in the 24 hours postoperative period
Time to the parturient's first ambulation
the time to start of each parturient movement in the 24 hours postoperative period
The analgesic satisfaction 24 hours after operation
parturients will be asked to report their satisfaction with pain management, assessed as 0 = weak, 1 = medium, 2 = good, 3 = very good, and 4 = excellent.

Full Information

First Posted
October 8, 2021
Last Updated
October 26, 2022
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05136118
Brief Title
Transversus Abdominis Plane Block for Post-operative Analgesia Following Cesarean Section
Official Title
Transversus Abdominis Plane Block: Ultra-sound Guided Versus the Modified Surgeon Assisted Approaches for Post-operative Analgesia Following Cesarean Section
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
August 30, 2022 (Actual)
Study Completion Date
October 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Postpartum analgesia is a common concern after Cesarean Section (CS). The quality of postoperative recovery is improved by opioid sparing pain control approaches. The transversus abdominis plane block (TAPB) is an effective technique for postpartum analgesia after cesarean section. Pregnancy results in thinning of the internal oblique aponeurosis; with increased incidence of missing the second pop to reach the transversus abdominis plane (TAP). The classic blind approach to the TAP is associated with several complications; so, it has been largely replaced by the ultrasound-guided approach to the TAP. The ultrasound-guided approach to the TAPB was first described by Hebbart and his colleagues in 2007.Ultrasound-guided TAPB improves the success of the block, reduces the volume of local anesthetic used and prevents the potential injury of adjacent structures. Surgical approach to the TAPB was also described, it is a quick and easy approach of establishing a reliable block. The surgeon performs an intra-abdominal approach to the TAPB; by which asepsis is easily attained, visible and tactile confirmation of correct needle placement may be achieved with no risk of damage to the viscera but care must be given to avoid injury of the inferior epigastric vessels.
Detailed Description
Compare the Transversus Abdominis Plane Block via the modified surgeon assisted approach (Study group), to the ultra-sound guided approach (Control group); as regards the post-operative analgesia following Cesarean Section.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia
Keywords
post-operative analgesia, Transversus Abdominis Plane Block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
308 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group MS
Arm Type
Active Comparator
Arm Description
The modified surgeon assisted approach for TAPB Before the closure of the peritoneum, TAPB will be performed; at the level of the umbilicus 8 to 10cms from the midline bilaterally. A sterile 100-mm 22-G insulated needle will be inserted perpendicular to the skin slightly directed towards the ipsilateral anterior superior iliac spine. After feeling the 2 pops of the external and the internal oblique aponeurosis by the anesthesiologist, the surgeon will confirm proper needle placement by his hand inside the abdominal cavity. The LA will be injected after negative aspiration and a bleb will be palpated by the surgeon as the injection continues. The same procedure will be repeated on the other side.
Arm Title
Group US
Arm Type
Active Comparator
Arm Description
The ultra-sound guided approach for TAPB. After abdominal wall closure, the linear probe of the ultra- sound will be placed perpendicular to the skin at the mid-axillary line between the iliac crest and the costal margin; the TAP will be located between the internal oblique and the transversus abdominis muscle. A sterile 100-mm 22-G insulated needle will be inserted perpendicular to the skin and the 2 pops of the external and the internal oblique aponeurosis will be also felt. The LA will be injected after negative aspiration and its spread in the plane will be observed. The same procedure will be repeated on the other side.
Intervention Type
Procedure
Intervention Name(s)
TAPB
Intervention Description
TAPB will be given to parturients whether by the modified surgeon assisted approach or by the ultra-sound guided approach.
Primary Outcome Measure Information:
Title
Time to rescue analgesia
Description
the time from the end of surgery until the first parturient's request for analgesia
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Efficacy of the modified surgeon assisted approach for TAPB on postoperative analgesia
Description
assessment of pain intensity at rest and on passive flexion of the hip and knee by the Numeric Pain Rating Score (NPRS) from 0 = no pain to 10 = worst pain. Assessment will be done at 2, 6, 12 and 24h postoperative.
Time Frame
6 months
Title
Number of parturients requiring postoperative analgesia
Description
defined as pethidine needed by each parturient in the 24 hours postoperative period
Time Frame
6 months
Title
Total dose of pethidine given
Description
defined as pethidine needed by each parturient in the 24 hours postoperative period
Time Frame
6 months
Title
Time to the parturient's first ambulation
Description
the time to start of each parturient movement in the 24 hours postoperative period
Time Frame
6 months
Title
The analgesic satisfaction 24 hours after operation
Description
parturients will be asked to report their satisfaction with pain management, assessed as 0 = weak, 1 = medium, 2 = good, 3 = very good, and 4 = excellent.
Time Frame
6 months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA physical status I and ∏ primigravidas aged 21-40 years BMI ˂ 40 body weight ˃ 60 kg singleton pregnancy gestational age of ≥37 weeks undergoing elective caesarean section under spinal anesthesia. Exclusion Criteria: Parturient refusal parturient with a BMI > 40 body weight < 60 kg ASA physical status ≥ III known local anesthetic (LA) allergy •contraindications to spinal anesthesia parturients who received analgesics in the past 24 hours infection at the site of the block.
Facility Information:
Facility Name
Ain-Shams University
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Transversus Abdominis Plane Block for Post-operative Analgesia Following Cesarean Section

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