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Postoperative Analgesic Efficacy of Trans Abdominis Plane Block

Primary Purpose

Post Operative Pain, Cesarean Section Complications

Status

Completed

Phase

Not Applicable

Locations

Pakistan

Study Type

Interventional

Intervention

Trans abdominis plane block

About this trial

This is an interventional prevention trial for Post Operative Pain focused on measuring TAP block, C-section, Spinal anesthesia, localized field effects, analgesia, Postoperative pain and Opioids

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Combined Military Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TAP block group

Placebo group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Postoperative opioid consumption

within 24hours after surgery

Secondary Outcome Measures

Pain intensity Score

Pain intensity at 6 hours,12 hours and 24 hours after surgery

Vomiting

frequency of vomiting within 24hours after surgery

Duration of First Rescue Analgesia

time after surgery when first dose of opioid required

Full Information

NCT ID

NCT05831501

First Posted

April 13, 2023

Last Updated

April 25, 2023

Sponsor

Armed Forces Hospital, Pakistan

1. Study Identification

Unique Protocol Identification Number

NCT05831501

Brief Title

Postoperative Analgesic Efficacy of Trans Abdominis Plane Block

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

June 1, 2022 (Actual)

Primary Completion Date

December 31, 2022 (Actual)

Study Completion Date

December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Armed Forces Hospital, Pakistan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post Operative Pain, Cesarean Section Complications

Keywords

TAP block, C-section, Spinal anesthesia, localized field effects, analgesia, Postoperative pain and Opioids

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

TAP block group

Arm Type

Experimental

Arm Description

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

Arm Title

Placebo group

Arm Type

No Intervention

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Trans abdominis plane block

Intervention Description

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

Primary Outcome Measure Information:

Title

Postoperative opioid consumption

Description

within 24hours after surgery

Time Frame

24 hours post cesarean section

Secondary Outcome Measure Information:

Title

Pain intensity Score

Description

Pain intensity at 6 hours,12 hours and 24 hours after surgery

Time Frame

from end of secarean section till 24 post operative hours

Title

Vomiting

Description

frequency of vomiting within 24hours after surgery

Time Frame

Within 24hours after surgery

Title

Duration of First Rescue Analgesia

Description

time after surgery when first dose of opioid required

Time Frame

Within 24hours after surgery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Facility Information:

Facility Name

Combined Military Hospital

City

Sargodha

State/Province

Punjab

Country

Pakistan

12. IPD Sharing Statement

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Postoperative Analgesic Efficacy of Trans Abdominis Plane Block

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