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Clinical Trials/CTRI/2024/08/073051
CTRI/2024/08/073051
Completed
Not Applicable

Effect of External Oblique Intercostal plane block and Rectus Abdominis plane block for postoperative pain in patient of laparoscopic cholecystectomy

Teerthanker Mahaveer Medical College and Research Centre1 site in 1 country70 target enrollmentStarted: August 11, 2025Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Teerthanker Mahaveer Medical College and Research Centre
Enrollment
70
Locations
1
Primary Endpoint
To evaluate tramadol consumption for postoperative 24 hours in both the group

Overview

Brief Summary

After Permission from College Research Committee (CRC) and Institutional Ethical Committee (IEC), TMMC&RC, Moradabad

Randomization will be done by computer generated techniques and patients will be assigned in to two group

Group A : External oblique intercostal block (20 ml of 0.25% bupivacaine) and rectus abdominis (20 ml of 0.25% bupivacaine)

Group B : IV analgesic will be administered as standard institutional protocol

After shifting the patient to operating room ASA monitor will be attached baseline values of heart rate (HR) Systolic blood pressure (SBP) Diastolic blood pressure (DBP) and oxygen saturation will be recorded

General anesthesia with endotracheal intubation will be administered according to standard protocol

EOIPB & RA will be administered by anesthesiologist after extubation.

Postoperative analgesia all patients were given INJ PCM 15mg/kg 8 hourly will be given , will be given first application of analgesic drug was administered after anesthesia induction.

NRS, Modified Aldrete’s Score will be assessed simultaneously

In postoperative period patients will be assessed for pain by numeric rating scale (NRS)

• NRS will be recorded at 15, 30, 60 minutes in PACU and 2,6,12,24 hours

• In the NRS evaluation 0 = no pain , 10 = worst pain

• Intravenous tramadol 50 mg ( rescue analgesia) will be given and recorded

when the pain >= 4on NRS

The recovery time will be considered from the last dose of drug administered till archiving Modified Aldrete’s Score of 9-10

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant and Investigator Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 70.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • 1.Patient posted for elective laparoscopic cholecystectomy giving informed and written consent
  • Patients of age 18-70 years.
  • BMI from 18.5 kg/m2 to 25 kg/m2 4.American Society of Anesthesiologists (ASA) physical status I-II patients.

Exclusion Criteria

  • 1.Coagulation disorders, liver/kidney disease.
  • Local infection at site of block.
  • Ho/ alergy ot study medications 4.Pregnancy.
  • 5.Chronic alcohol and drug abuse.

Outcomes

Primary Outcomes

To evaluate tramadol consumption for postoperative 24 hours in both the group

Time Frame: To evaluate tramadol consumption for postoperative 24 hours in both the group

Secondary Outcomes

  • 1.To evaluate the Numeric Rating Scale (NRS) scores for postoperative 24 hours in both the group.(2.To evaluate the post operative recovery time in both the groups.)

Investigators

Sponsor
Teerthanker Mahaveer Medical College and Research Centre
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Gami meetkumar vrajlal

Teerthanker Mahaveer Medical College and Research Centre

Study Sites (1)

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