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Clinical Trials/CTRI/2025/07/090252
CTRI/2025/07/090252
Not yet recruiting
Phase 4

Comparison Between Ultrasound Guided Bilateral External Oblique Intercostal Plane Block And Pre-incisional Port Site Local Infiltration For Postoperative Analgesia in Undergoing Laparoscopic Cholecystectomy

Government Medical College Baroda1 site in 1 country124 target enrollmentStarted: July 18, 2025Last updated:

Overview

Phase
Phase 4
Status
Not yet recruiting
Sponsor
Government Medical College Baroda
Enrollment
124
Locations
1
Primary Endpoint
Time to assess first rescue analgesia (Inj. Tramadol in 2mg/kg)

Overview

Brief Summary

The Purpose of this study is to compare post-operative analgesia after Bilateral External Oblique Intercostal Plane Block and Pre-incisional port site local infiltration, postoperative total requirenment of analgesic drugs, assess hemodynamic parameter, early recovery in adult patients undergoing laparoscopic cholecystectomy.

The patients will be randomly allocated into two groups by using computerised randomisation in a 1:1 ratio to undergo bilateral ultrasound guided external oblique intercostal plain block and pre-incisional port-site instillation of local anaesthetics.

In group B, patient will be given bilateral ultrasound guided external oblique intercostal plane block after giving general anaesthesia.

 In group L, patient will be given pre-incisional port-site local infiltration after giving general anaesthesia.

This study may superior in post operative analgesia with higher safety margin in patients laparoscopic cholecystectomy with ultrasound guided bilateral external oblique intercostal plane block as a part of multimodal analgesia.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Outcome Assessor Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 65.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Age 18-65 years ASA Grade One And TWO patient schedule for elective laparoscopic cholecystectomy patient able to give verbal and informed consent patient able to understand VAS regarding assessment of pain.

Exclusion Criteria

  • Refusal of patient History of allergy to local anaesthetic drug Skin infection at puncture site Coagulation disorders Cardio pulmonary/hepatorenal disease Pregnancy.

Outcomes

Primary Outcomes

Time to assess first rescue analgesia (Inj. Tramadol in 2mg/kg)

Time Frame: Till 24 hours

Time interval from block performance to requirement of first rescue analgesia.

Time Frame: Till 24 hours

Secondary Outcomes

  • To evaluate post operative analgesia using visual analogue scale (VAS) measured at 0,1,2,4,6,8,12,18,24 hours at rest and on movement(Intra-operative dexmedetomidine requirement)

Investigators

Sponsor
Government Medical College Baroda
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Gandev J Chaudhari

Government Medical College Baroda

Study Sites (1)

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