Postoperative Analgesic Efficacy of Trans Abdominis Plane Block

Not Applicable

Completed

• Conditions: Cesarean Section Complications; Post Operative Pain
• Interventions: Procedure: Trans abdominis plane block

• Registration Number: NCT05831501
• Lead Sponsor: Armed Forces Hospital, Pakistan

Brief Summary

Transverse abdominis plane (TAP) block is an effective method to manage postoperative pain in patients with midline abdominal wall incisions. It is used frequently in many lower abdominal surgeries however its use after caesarean section is still new, and fewer studies are available. We conducted this study to see the analgesic effect of TAP block after caesarean section.

Detailed Description

The study is being conducted, at Combined Military Hospital Sargodha, Pakistan, to compare the analgesic efficacy of TAP block in providing post-caesarean analgesia with the control group, in terms of mean postoperative use of opioids after caesarean delivery. Sixty patients have been randomly selected using non-probability, consecutive sampling, and applying inclusion and exclusion criteria. The study design is a randomized controlled trial with thirty patients in each group undergoing elective caesareans. All patients will be given spinal anaesthesia with 1.5ml of 0.75% hyperbaric bupivacaine for a caesarean section. Patients in Group A will receive bilateral TAP block with 20ml of 0.25% bupivacaine while 20 ml of saline will be injected in patients of Group B on both sides of midline after caesarean section, in addition to intravenous ketorolac 8hrly. The intensity of pain, total opioid consumption, presence of vomiting, and sedation will be noted until 24 hours after the surgery.

Study Timeline

• Study Start: 2022-06-01
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-04
• Study First Submitted: 2023-04-13
• Study First Submitted QC: 2023-04-25
• Last Update Submitted: 2023-04-25
• Study First Posted: 2023-04-26
• Last Update Posted: 2023-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Elective Caesarean section
• ASA 1-3
• 20yrs to 45yrs

Exclusion Criteria

• Emergency Surgery
• known allergy to local anaesthetic
• severe pre-eclampsia
• placenta accreta
• ASA 4
• Coagulopathy
• Hemodynamically unstable

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAP block group	Trans abdominis plane block	At the end of the cesarean section, a TAP block will be given by Injecting of 20ml 0.25% Bupivacaine on both sides of the midline using ultrasound-guided subcostal approach

Primary Outcome Measures

Name	Time	Method
Postoperative opioid consumption	24 hours post cesarean section	within 24hours after surgery

Secondary Outcome Measures

Name	Time	Method
Pain intensity Score	from end of secarean section till 24 post operative hours	Pain intensity at 6 hours,12 hours and 24 hours after surgery
Duration of First Rescue Analgesia	Within 24hours after surgery	time after surgery when first dose of opioid required
Vomiting	Within 24hours after surgery	frequency of vomiting within 24hours after surgery

Trial Locations

Locations (1)

Combined Military Hospital; 🇵🇰 Sargodha, Punjab, Pakistan