It is randomized controlled trial to know the efficacy of intrathecal morphine combined with 0.75% ropivacaine heavy for postoperative analgesia in laparoscopic cholecystectomy.

Not yet recruiting

• Conditions: Cholecystitis, unspecified,

• Registration Number: CTRI/2022/08/045034
• Lead Sponsor: NA

Brief Summary

The study is randomazied ,double blinded ,controlled trial . It is to  assess the efficacy of intrathecal morphine with 0.75% ropivacaine heavy for postoperative analgesia in elective laparoscopic cholecystectomy  which will reduce  analgesic requirement during 24 hours.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-09
• Last Update Posted: 2022-08-27

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 102

Inclusion Criteria

All adult male and female patients of age between 18-69 years and belonging to American society of Anaesthesiologist Physical Status I and II posted for elective laparoscopic cholecystectomy.

Exclusion Criteria

• Patients of age more than 70years.
• Any allergy to local anaesthetic, opioids, morphine, NSAIDS or paracetamol.
• All contraindication to spinal anaesthesia.
• Use of abdominal drains for specific procedure related cause.
• Any surgery of duration more than 3 hours.
• Patient with body mass index of more than 30 Kg/m2 or any subject requiring ICU admission.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To observe postoperative pain score using NRS scale. (it is a segmented numeric version of visual analog scale in which a patient selects a whole number (0-10) that reflects the intensity of his/her pain.)	Postoperatively for every 30min for first 2 hours and then after 4hours, 8 hours, 12hours and 24hours.
Time of first dose of rescue analgesia in hours (from T0 – time of arrival in post anaesthetic care unit). Inj. Tramadol 1.5mg/kg will be administered as rescue analgesic in 100ml normal saline over 15minutes, maximum dose not to exceed 100mg.	Postoperatively for every 30min for first 2 hours and then after 4hours, 8 hours, 12hours and 24hours.

Secondary Outcome Measures

Name	Time	Method
To observe postoperative pain score using NRS scale.	Time of first dose of rescue analgesia in hours from T0 time of arrival in post anaesthetic care unit. Inj. Tramadol 1.5mg/kg will be administered as rescue analgesic in 100ml normal saline over 15minutes, maximum dose not to exceed 100mg.Total dose of rescue analgesia consumed in 24hours in mg

Trial Locations

Locations (1)

Kalinga Institute of Medical Sciences; 🇮🇳 Khordha, ORISSA, India

Kalinga Institute of Medical Sciences

🇮🇳Khordha, ORISSA, India

Saman beg

Principal investigator

7985032566

saman.beg.dr18@gmail.com