Postoperative Analgesic Efficacy of Trans Abdominis Plane Block

Sponsor

Armed Forces Hospital, Pakistan (Other)

Overall Status

Completed

CT.gov ID

NCT05831501

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

8.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain Cesarean Section Complications	Procedure: Trans abdominis plane block	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 1, 2022

Actual Primary Completion Date :

Dec 31, 2022

Actual Study Completion Date :

Dec 31, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Postoperative opioid consumption [24 hours post cesarean section]
within 24hours after surgery

Secondary Outcome Measures

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
Vomiting [Within 24hours after surgery]
frequency of vomiting within 24hours after surgery
Duration of First Rescue Analgesia [Within 24hours after surgery]
time after surgery when first dose of opioid required

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Combined Military Hospital	Sargodha	Punjab	Pakistan

Sponsors and Collaborators

Armed Forces Hospital, Pakistan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

arshad khushdil, clinical professor, Armed Forces Hospital, Pakistan

ClinicalTrials.gov Identifier:

NCT05831501

Other Study ID Numbers:

IERB/02/2023

First Posted:

Apr 26, 2023

Last Update Posted:

Apr 26, 2023

Last Verified:

Apr 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by arshad khushdil, clinical professor, Armed Forces Hospital, Pakistan

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

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Apr 26, 2023