Comparison of Rescue Analgesia Requirement in Patients Undergoing Laparoscopic Cholecystectomy After Transversus Abdominal Plane (tap) Block Vs Local Anesthetic Wound Infiltration At the End of Surgery

NCT06803966 | Completed Phase 2

• 1 other identifier: FazaiaRuthPfauMC
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

patients undergoing laparoscopic cholecystectomy will be diveided into 2 groups A \& B . Group A will receive local anesthetic wound infiltration and group B will receive Transversus abdominal plane block as a post operative analgesia. the time for request of first rescue analgesia between the 2 groups will be compared

Conditions

Rescue Analgesia

Keywords

transversus abdominal plane block; local anesthetic wound infiltration

Outcome Measures

Primary Outcomes (1)

• first rescue analgesia

  time of requirement of first rescue analgesia will be compared between group a and group b

  from enrollment to 24 hours post operation

Study Arms (2)

Group A: local anesthetic infiltration at port sites

ACTIVE COMPARATOR

Group A patient's will receive local anesthetic wound infiltration at port sites with inj Bupivacaine (Bupivacaine Hydrochloride) 0.5%

Other: Post Operative Analgesia

Group B : TAP block

ACTIVE COMPARATOR

Group b will receive Transversus Abdominal Plane (TAP) block at both sides using inj bupivacaine (Bupivacaine Hydrochloride) 0.25%

Other: Post Operative Analgesia

Interventions

Post Operative Analgesia OTHER

Group A will receive local wound infiltration at port sites with inj bupivacaine (bupivacaine Hydrochloride) 0.5 % Group B will receive Transversus Abdominal Plane Block on both sides by inj bupivacaine (bupivacaine Hydrochloride) 0.25%

Also known as: Group A : local wound infiltration, Group B : TAP block

Group A: local anesthetic infiltration at port sites; Group B : TAP block

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• both gender patients undergoing elective laparoscopic cholecystectomy ASA physical status classification 1 \& 2

You may not qualify if:

• patients with chronic pain patients unable to understand NRS pain scale conversion of laparoscopic to open cholecystectomy

Sponsors & Collaborators

• Fazaia Ruth Pfau Medical College: lead

Study Sites (1)

PAF hospital Faisal base

Karachi, Sindh, 20006, Pakistan

Location

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: group A will get local ansthetic wound infiltration at port site and Group b will get Transversus abdominal plane block

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: January 31, 2025
• Study Start: August 5, 2024
• Primary Completion: January 11, 2025
• Study Completion: January 11, 2025
• Last Updated: January 31, 2025

Record last verified: 2025-01

Locations

PA (1)