Postoperative Analgesic Efficacy of Trans Abdominis Plane Block

Postoperative Analgesic Efficacy of Trans Abdominis Plane Block in Women Undergoing Caesarean Section, a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section Complications; Post Operative Pain
• Intervention / Treatment: Procedure: Trans abdominis plane block

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Sargodha, Punjab, Pakistan
      • Combined Military Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TAP block group; 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	Procedure: Trans abdominis plane block; Ultrasound guided infiltration of local anaesthetic bupivacaine via 22G Quincke needle between internal oblique and trans abdominis muscle layers in abdominal wall.
No Intervention: Placebo group; At the end of the cesarean section, 20 ml of saline will be injected on both sides of the midline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative opioid consumption	within 24hours after surgery	24 hours post cesarean section

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Armed Forces Hospital, Pakistan

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: April 13, 2023
• First Submitted That Met QC Criteria: April 25, 2023
• First Posted (Actual): April 26, 2023

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 25, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: TAP block, C-section, Spinal anesthesia, localized field effects, analgesia, Postoperative pain and Opioids
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: IERB/02/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No