Comparing pain relief property of bupivacaine alone and bupivacaine with dexmedetomidine when given inside abdomen after operation of gall bladder with laparoscopic method

Not Applicable

Not yet recruiting

• Conditions: Other cholelithiasis,

• Registration Number: CTRI/2020/10/028678
• Lead Sponsor: Vivek Vishal

Brief Summary

The primary purpose of this study is to analyse post operative  analgesic efficacy both in terms of duration and degree of analgesia along with haemodynamic safety, of bupivacaine alone or in combination with dexmedetomidine when given intraperitoneally at the end of surgery in patients undergoing laparoscopic cholecystectomy.After taking informed consent patients will be allocated into either of two study groups keeping in mind blinding and patient group allocation concealment as per my protocol.Patients will be given intaperitoneal bupivacaine alone or bupivacaine with dexmedetomidine at the end of surgery before removal of trocar as per group allocation of patient.All patients will be shifted to PACU where VAS score,time to first rescue analgesic,24 hours post operative total analgesic requirement,PR,MAP,SPO2,Ramsay sedation score and any complication if any will be recorded at 0,1,2,3,4,6,8,12,18 and 24 hours in post operative period.All data will be analysed statistically.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-11
• Last Update Posted: 2020-10-15

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1.Patients posted for elective laparoscopic cholecystectomy 2.ASA physical status I & II 3.BMI >18.5 & <30.

Exclusion Criteria

• 1.Patients refusal 2.Patients not satisfying above inclusion criteria 3.Allergic to study drugs 4.Pregnant or breast-feeding patient 5.Patients with cardiac,respiratory,liver and renal diseases 6.Patients with baseline heart rate<55/min.
• 7.Patients with AV heart blocks 8.Laparoscopic cholecystectomy converted to open cholecystectomy 9.If any other surgery,combined with laparoscopic cholecystectomy in the same sitting like incisional hernia,umbilical hernia etc.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Post operative pain relief using visual analogue scale(0-100mm)	All parameters will be recorded at 0,1,2,3,4,6,8,12,18 and 24 hours in post operative period
2.Time to first rescue analgesic	All parameters will be recorded at 0,1,2,3,4,6,8,12,18 and 24 hours in post operative period
3.24 hours post operative total analgesic requirement	All parameters will be recorded at 0,1,2,3,4,6,8,12,18 and 24 hours in post operative period

Secondary Outcome Measures

Name	Time	Method
1.Haemodynamic variables(PR,MAP,SPO2)	2.Ramsay sedation score

Trial Locations

Locations (1)

Department of Anesthesiology, J.L.N. Main Hospital and Research Centre; 🇮🇳 Durg, CHHATTISGARH, India

Department of Anesthesiology, J.L.N. Main Hospital and Research Centre

🇮🇳Durg, CHHATTISGARH, India

Vivek Vishal

Principal investigator

9359271359

drvivekvishal84@gmail.com