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CTRI Number  CTRI/2019/07/020466 [Registered on: 31/07/2019] Trial Registered Retrospectively
Last Modified On: 19/09/2019
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To compare the analgesic efficacy of local anesthetic bupivacaine when combined with fentanyl or dexmeditomidine in laproscopic cholecystectomy 
Scientific Title of Study   Comparison of analgesic efficacy of intraperitoneal bupivacaine with dexmedetomidine or fentanyl as adjuvants, in patients undergoing ambulatory laparoscopic cholecystectomy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ripudaman Singh 
Designation  Post Graduate Student 
Affiliation  Dr Rajendra Prasad Government Medical College, Kangra at Tanda 
Address  Department of Anesthesiology Dr.R.P.G.M.C Kangra at Tanda

Kangra
HIMACHAL PRADESH
176001
India 
Phone  7807293819  
Fax    
Email  jelly310@hotmail.co.uk  
 
Details of Contact Person
Scientific Query
 
Name  Dr Bharti Gupta 
Designation  Associate Professor 
Affiliation  Dr Rajendra Prasad Government Medical College 
Address  Department of Anaesthesia DrRPGMC Tanda at Kangra

Kangra
HIMACHAL PRADESH
176001
India 
Phone  9418044928  
Fax    
Email  drbharti203@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Ripudaman Singh 
Designation  Post Graduate Student 
Affiliation  Dr Rajendra Prasad Government Medical College 
Address  Department of Anaesthesia DrRPGMC Tanda at Kangra

Kangra
HIMACHAL PRADESH
176001
India 
Phone  9816766170  
Fax    
Email  jelly310@hotmail.co.uk  
 
Source of Monetary or Material Support  
Department of Anesthesiology, Dr.R.P.G.M.C. Kangra at Tanda-176001 H.P. 
 
Primary Sponsor
Modification(s)  
Name  Dr Sudarshan Kumar 
Address  Head and Professor Department of Anaesthesia Dr RPGMC Tanda at Kangra 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ripudaman Singh  Dr. Rajendra Prasad Government Medical College  Surgery Operation Theatre, Super Speciality Block, 3rd floor
Kangra
HIMACHAL PRADESH 
9816766170

jelly310@hotmail.co.uk 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K819||Cholecystitis, unspecified, Symptomatic Cholecystitis and Cholelithiasis posted for Laparoscopic Cholecystectomy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Comparison Of Intraperitoneal bupivacaine alone vs intraperitoneal bupivavaine with demedetomidine or fentanyl  According to the random number, the patient will be allocated to one of the three groups- Group 1(Control Group) will receive bupivacaine intraperitoneally over the liver bed through the instillation port of laparoscope with 20 ml of 0.25% bupivacaine. Group 2(Dexmedetomidine group) will receive 20 ml of 0.25% bupivacaine +1µg/kg of dexmedetomidine (10 ml of 0.5% bupivacaine+1µg/kg of dexmedetomidine, diluted to total of 20 ml with 0.9% NS) intraperitoneally over the liver bed through the instillation port of laparoscope. Group 3(fentanyl group) will receive 20 ml of 0.25% bupivacaine + 2µg/kg of fentanyl(10 ml of 0.5% bupivacaine+2µg/kg of fentanyl, diluted to total of 20 ml with 0.9% NS) intraperitoneally over the liver bed through the instillation port of laparoscope. 
Intervention  Intraperitoneal bupivacaine alone vs intraperitoneal bupivavaine with demedetomidine or fentanyl  According to the random number, the patient will be allocated to one of the three groups- Group 1(Control Group) will receive bupivacaine intraperitoneally over the liver bed through the instillation port of laparoscope with 20 ml of 0.25% bupivacaine. Group 2(Dexmedetomidine group) will receive 20 ml of 0.25% bupivacaine +1µg/kg of dexmedetomidine (10 ml of 0.5% bupivacaine+1µg/kg of dexmedetomidine, diluted to total of 20 ml with 0.9% NS) intraperitoneally over the liver bed through the instillation port of laparoscope. Group 3(fentanyl group) will receive 20 ml of 0.25% bupivacaine + 2µg/kg of fentanyl(10 ml of 0.5% bupivacaine+2µg/kg of fentanyl, diluted to total of 20 ml with 0.9% NS) intraperitoneally over the liver bed through the instillation port of laparoscope.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA physical status I and II, who have to undergo ambulatory laparoscopic cholecystectomy for symptomatic cholecystitis and cholelithiasis  
 
ExclusionCriteria 
Details  1. BMI less than 18 or > 30
2. Patients who are converted into open cholecystectomy
3. Patients who have bleeding liver bed
4. Psychiatric patient
5. Patients who have coagulation disorder
6. Patients who have allergy to local anaesthetics, dexmedetomidine or fentanyl
7. Patients in whom the drains are to be kept postoperatively.
8. Patients of heart block or those having heart rate less than 50.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
To assess the recovery profile of patients undergoing ambulatory laparoscopic cholecystectomy  The time 0 starts when patient is shifted to PACU,
1, 2, 4, 6 hours interval after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
To assess postoperative analgesia, requirement of rescue analgesia, haemodynamic stability and other side effects  The time 0 starts when patient is shifted to PACU,
1, 2, 4, 6 hours interval after surgery 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
Final Enrollment numbers achieved (Total)= "90"
Final Enrollment numbers achieved (India)="90" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/08/2017 
Date of Study Completion (India) 16/07/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   none yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Laparoscopic cholecystectomy is currently the most accepted surgical technique for cholelithiasis as compared to open cholecystectomy.1 Laparoscopic procedures have many advantages over open procedures such as lesser haemorrhage, better cosmetic results, lesser postoperative pain and shorter recovery time leading to shorter hospital stay and less expenditure.2 Laparoscopic cholecystectomy would appear to be an ideal operation for ambulatory surgery because of short duration, small surgical incisions, a low rate of immediate complications and  maintenance of gastrointestinal homeostasis.3

Pain in laparoscopic surgery results from stretching of the intraabdominal cavity,4 peritoneal inflammation, and diaphragmatic irritation caused by residual carbon‑dioxide in the peritoneal cavity.5 A single agent is unlikely to treat all three types of pain and a multimodal approach will be required to alleviate the pain. Hence many methods have been proposed to relieve postoperative pain following laparoscopic cholecystectomy.6

As a part of multimodal analgesic regimen, opioids have always remained as the preferred agent. However, the use of opioids can result in significant adverse effects including sedation, nausea, vomiting and respiratory depression thus delaying early ambulation of patients. Therefore, alternative approaches which reduce the requirement of strong opioids postoperatively are required. Drugs like paracetamol, diclofenac and COX-2 inhibitors, may not meet all requirements of post-surgical patients.

Intraperitoneal instillation of local anaesthetic agents has become an important method to control postoperative pain, nausea, vomiting and reduced hospital stay.7,8 Intraperitoneal instillation of local anaesthetic agents alone6 or in combination with opioids,9,10 ∝ 2 agonists such as clonidine11,dexmedetomidine9 have been found to reduce post‑operative pain following laparoscopic cholecystectomy.

The local anaesthetic agents provide antinociception by affecting nerve membrane associated proteins and by inhibiting the release and action of prostaglandins which stimulates the nociceptors and cause inflammation.12

There are very few studies in literature which have examined the analgesic effects of α 2 agonists intraperitoneally. The antinociceptive effects of dexmedetomidine occur at dorsal root neuron level, where it blocks the release of substance P in the nociceptive pathway and through action on inhibitory G protein, which increases the conductance through potassium channels.13

Fentanyl is a potent, synthetic opioid pain medication with a rapid onset and short duration of action. It is a strong agonist at the μ-opioid receptors. Fentanyl is 50 to 100 times more potent than morphine. Despite being a more potent analgesic, fentanyl tends to induce less nausea, as well as less histamine-mediated itching, in relation to morphine.

Since there are a few studies which have compared the nociceptive effects of intraperitoneal fentanyl to intraperitoneal dexmedetomidine, we have proposed a study to compare the effects of combination of  intraperitoneal  dexmedetomidine and  bupivacaine to intraperitoneal fentanyl and bupivacaine and to intraperitoneal bupivacaine alone in patients undergoing ambulatory laparoscopic cholecystectomy.

 

 

 

 
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