Postoperative Analgesic Efficacy of Trans Abdominis Plane Block

NCT ID: NCT05831501

Last Updated: 2023-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2022-12-31

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.

Conditions

Post Operative Pain; Cesarean Section Complications

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Trans abdominis plane block

Intervention Type: PROCEDURE

Ultrasound guided infiltration of local anaesthetic bupivacaine via 22G Quincke needle between internal oblique and trans abdominis muscle layers in abdominal wall.

Placebo group

At the end of the cesarean section, 20 ml of saline will be injected on both sides of the midline

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Armed Forces Hospital, Pakistan

OTHER

Sponsor Role: lead

Responsible Party

arshad khushdil

clinical professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Combined Military Hospital

Sargodha, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

IERB/02/2023

Identifier Type: -

Identifier Source: org_study_id