Skip to main content
Clinical Trials/CTRI/2025/08/093706
CTRI/2025/08/093706
Not yet recruiting
Phase 2/3

Comparative Evaluation of Dexamethasone as an adjuvant to 0.25 percent Ropivacaine vs 0.25 percent Ropivacaine with Normal Saline in External Oblique Intercostal Plane Block in patients undergoing Laparoscopic Cholecystectomy

Not provided1 site in 1 country60 target enrollmentStarted: September 5, 2025Last updated:

Overview

Phase
Phase 2/3
Status
Not yet recruiting
Enrollment
60
Locations
1
Primary Endpoint
24 hour tramadol consumption in mg

Overview

Brief Summary

Pain following laparoscopic cholecystectomy is a common complaint that prolongs hospital stay and therefore increases morbidity. Most patients experience mild to moderate pain after laparoscopic cholecystectomy. External oblique intercostal plane block is a novel block, which has been described as an important modification of the fascial plane blocks that can consistently involve the upper lateral abdominal walls. Ropivacaine is a long acting local anaesthetic and has a documented better safety profile than other local anaesthetics. . Dexamethasone is a highly potent, long-acting glucocorticoid with analgesic, antiemetic, and anti-inflammatory properties, and when used as an adjuvant in peripheral nerve blocks, increases the duration of analgesia with minimal side effects and has an added advantage in decreasing postoperative nausea and vomiting. The proposed study aims to assess the efficacy of dexamethasone as an adjuvant to ropivacaine in comparison to plain ropivacaine on External oblique intercostal plane block in patients undergoing laparoscopic cholecystectomy as a part of multimodal analgesia. We hypothesize that the addition of dexamethasone 8 mg to ropivacaine 0.25 percent in  External oblique intercostal plane block would prolong the analgesic effect and reduce 24hr tramadol consumption when compared with plain ropivacaine 0.25 percent  in patients undergoing laparoscopic cholecystectomy.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant, Investigator and Outcome Assessor Blinded

Eligibility Criteria

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

Inclusion Criteria

  • With ASA physical status classification of I and II Scheduled to undergo elective laparoscopic cholecystectomy surgery.

Exclusion Criteria

  • Patient refusal Coagulation disorders Liver or kidney disease Abdominal surgery history Infection in the block application area Chronic opioid use Local anaesthetic allergy Pregnancy or BMI less than 18 or more than 35 Diabetes Mellitus.

Outcomes

Primary Outcomes

24 hour tramadol consumption in mg

Time Frame: 15,30,60 mins | 2,6,12,24 hours

Secondary Outcomes

  • Sedation Score(15,30,60 mins)
  • Post Operative Nausea and Vomiting Score(15,30,60 mins)
  • Blood glucose levels 6hrs after block(6 hrs)
  • Numerical Rating Scale(15,30,60 mins)

Investigators

Sponsor
Not provided
Responsible Party
Principal Investigator
Principal Investigator

Dr Keerthana R

Ayushman Hospital and Health Services

Study Sites (1)

Loading locations...

Similar Trials