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Clinical Trials/NCT06803966
NCT06803966
Completed
Phase 2

Comparison of Rescue Analgesia Requirement After Transversus Abdominal Plane (TAP) Block Vs Local Anesthetic Wound Infiltration After Laparoscopic Cholecystectomy

Fazaia Ruth Pfau Medical College1 site in 1 country74 target enrollmentStarted: August 5, 2024Last updated:

Overview

Phase
Phase 2
Status
Completed
Sponsor
Fazaia Ruth Pfau Medical College
Enrollment
74
Locations
1
Primary Endpoint
first rescue analgesia

Overview

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

Detailed Description

After acquiring approval from Institutional Review Board, the work on the study will begin. The patients planned to undergo elective laparoscopic cholecystectomy first appear for pre-anesthesia assessment and here all relevant baseline tests and demographics (age, weight, ASA score, co morbid and allergies) will be recorded. The patient meeting the inclusion criteria will be explained about the study in the language they understand, its benefits, risks and any other relevant queries will be heard and answered. Those willing to participate will be enrolled into the study, after written consent. Confidentiality of the study subjects will be assured throughout. Data will only be accessible to the principal investigator.

Patients will be assigned either in Group A or Group B using sequentially numbered opaque sealed envelope protocol. Both patients and study investigators will be blinded to study groups. Only an anesthetist who will prepare the medication and will not be part of this study, will have correct knowledge of group identification.

On the day of operation, after patient is shifted to the operating room, monitors will be attached and vitals including Blood pressure, heart rate, mean arterial blood pressure, SpO2 and ETCO2 will be continuously monitored. Patient will be pre medicated by 0.1 mg/kg nalbuphine. For induction of anesthesia, 2 mg/kg propofol and 0.5 mg/kg Atracurium as a relaxant will be given. Anesthesia will be maintained on Isoflurane. Before the start of procedure NG tube will be inserted.

At the end of surgery before extubating, Injection ondansetron 0.15 mg/kg IV will be given to the patient. Next, as patients will be divided into two groups via closed envelope method, Group A will get local anesthetic wound infiltration and group B will receive TAP block. Local Anesthetic infiltration will be given with 20ml of 0.5% bupivacaine (5ml at each port site). TAP block will be given as 0.25% bupivacaine 20ml on each side, using ultrasound guidance.

After extubation, patient will be shifted to post surgical ward where they will be kept under close monitoring. Pain status will be monitored using the NRS at following hours 0, 2, 4, 8, 12, 24 and/or when patient complains. Rescue analgesia will be given by injection Toradol as 30 mg IV, when patient categorizes the pain as 4 or more according to NRS. This time at which rescue analgesia is given will be recorded.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

first rescue analgesia

Time Frame: from enrollment to 24 hours post operation

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Fazaia Ruth Pfau Medical College
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Sumbul Andleeb

Principal Investigator

Fazaia Ruth Pfau Medical College

Study Sites (1)

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