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Clinical Trials/NCT05136118
NCT05136118
Completed
Not Applicable

Transversus Abdominis Plane Block: Ultra-sound Guided Versus the Modified Surgeon Assisted Approaches for Post-operative Analgesia Following Cesarean Section

Ain Shams University1 site in 1 country308 target enrollmentNovember 1, 2021
ConditionsAnalgesia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Analgesia
Sponsor
Ain Shams University
Enrollment
308
Locations
1
Primary Endpoint
Time to rescue analgesia
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2021
End Date
October 25, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ghada M.Samir

Assistant Professor of Anesthesia, Intensive care and Pain Management

Ain Shams University

Eligibility Criteria

Inclusion Criteria

  • ASA physical status I and ∏
  • primigravidas
  • aged 21-40 years
  • 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.

Outcomes

Primary Outcomes

Time to rescue analgesia

Time Frame: 6 months

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

Secondary Outcomes

  • Efficacy of the modified surgeon assisted approach for TAPB on postoperative analgesia(6 months)
  • Number of parturients requiring postoperative analgesia(6 months)
  • Total dose of pethidine given(6 months)
  • Time to the parturient's first ambulation(6 months)
  • The analgesic satisfaction 24 hours after operation(6 months)

Study Sites (1)

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