A study to evaluate post operative analgesic effects of intraperitoneal instillation of bupivacaine with morphine and bupivacaine with buprenorphine for laproscopic cholecystectomy

Not yet recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2023/01/048937

Lead Sponsor: Dr Ramesh Kumar PB

Brief Summary: This is a Randomized, Double-Blinded study to asess, compare and evaluate post operative analgesic effects of intraperitoneal instillation of 25ml 0.25% bupivacaine and 2mg morphine versus 25ml 0.25% bupivacaine and 0.3mg buprenorphine to provide effective post operative pain relief in patients undergoing laparoscopic cholecystectomy under general anesthesia. Pre anaesthetic examination will be done and standard NPO guidelines will be followed. Premedication inj.pantoprazole 40mg intravenous, inj.ondansteron 4mg intravenous will be given Patients aged between 18year and 60year belonging to American Society of Anaesthesiology (ASA) I and II were randomized into two groups i.e BM and BB group BM group will be receiving intraperitoneal instillation of 25ml 0.25%bupivacaine and 2mg morphine and BB group will be receiving intraperitoneal instillation of 25ml 0.25%bupivacaine and 0.3mg buprenorphine and these medications will be given after peritoneal wash and suctioning through intraperitoneal instillation .The drug solution will be prepared by doctor who does not participate in the study. All patients will receive same anaesthesia method in each group. Patients in each group will be monitored for electrocardiogram(ECG),heart rate ,oxygen saturation (SpO2 saturation) and non invasive blood pressure(NIBP), end tidal carbon dioxide(EtCO2) Post operative pain will be evaluated using Visual Analog scale (pain score 0 -10) and verbal rating scale(VRS) for 24hrs after surgery .The post operative pain outcome will be reported at 0 and 30min 1,4,8,12,16,24hr. The cut off value for VAS is 4 for indication of rescue analgesic . At VAS>= 4 ,rescue analgesics will be administered on request, inj. diclofenac sodium75mg intravenously post operatively.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Patients willing to give written informed consent.
ASA physical status I and II patients.
Patients undergoing elective laparoscopic surgeries.

Exclusion Criteria

Patients having a known allergy to the study drug.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To assess analgesic effects	Pain Assessment will be done at 0 minutes,30 minutes, 1 hour, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours

Secondary Outcome Measures

Name	Time	Method
Overall Safety of drugs	0 minutes,30 minutes, 1 hour, 4 hours, 8 hours, 12 hours, 16 hours, 24 hours

Trial Locations

Locations (1): BGS Global Institute of Medical Sciences
🇮🇳
Bangalore, KARNATAKA, India
BGS Global Institute of Medical Sciences
🇮🇳Bangalore, KARNATAKA, India
Dr Ramesh Kumar PB
Principal investigator
9448279414
drrameshkumarpb@gmail.com