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CTRI Number  CTRI/2019/01/017247 [Registered on: 25/01/2019] Trial Registered Prospectively
Last Modified On: 18/01/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Process of Care Changes 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effect of peritoneal local anesthetic plus sedative-analgesics instillation on post-operative pain relief after laparoscopic surgeries. 
Scientific Title of Study   Comparison of effect of intraperitoneal instillation of additional dexmedetomidine or clonidine along with bupivacaine for post-operative analgesia following laparoscopic cholecystectomy: a prospective, randomized double blind, controlled study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Thottikat kaarthika 
Designation  MD 
Affiliation  SVIMS 
Address  Department of anesthesiology SVIMS University Tirupathi Chittoor ANDHRA PRADESH INDIA 517507

Chittoor
ANDHRA PRADESH
517507
India 
Phone  9908888134  
Fax    
Email  karthika.mohan07@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  ALOKA SAMANTARAY 
Designation  PROFESSOR HEAD 
Affiliation  SVIMS 
Address  Department of anesthesiology SVIMS University Tirupathi Chittoor ANDHRA PRADESH INDIA 517507

Chittoor
ANDHRA PRADESH
517507
India 
Phone  9493547653  
Fax    
Email  aloksvims@gmail.com  
 
Details of Contact Person
Public Query
 
Name  ALOKA SAMANTARAY 
Designation  PROFESSOR HEAD 
Affiliation  SVIMS 
Address  Department of anesthesiology SVIMS University Tirupathi Chittoor ANDHRA PRADESH INDIA 517507

Chittoor
ANDHRA PRADESH
517507
India 
Phone  9493547653  
Fax    
Email  aloksvims@gmail.com  
 
Source of Monetary or Material Support  
Sri Venkateswara institute of medical Sciences Tirupati District: Chitoor. AndhraPradesh.INDIA PIN 517507 
 
Primary Sponsor  
Name  SVIMS 
Address  Department of anesthesiology SVIMS University Tirupathi Chittoor ANDHRA PRADESH INDIA 517507 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
Sri Venkateswara institute of medical Sciences  Tirupati District:Chitoor AndhraPradesh PIN 517507 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Aloka Samantaray  Sri Venkateswara Institute of Medical Sciences  Department of Anaesthesiolgy and Critical Care, Anaesthesiology Office room Unit 1 Tirupati District:Chitoor AndhraPradesh PIN 517507
Chittoor
ANDHRA PRADESH 
9493547653

aloksvims@gmail.com 
 
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: K801||Calculus of gallbladder with othercholecystitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Clonidine  Intraperitoneal Bupivacaine with clonidine infiltration 
Intervention  Dexmedetomidine  Intraperitoneal Bupivacaine with dexmedetomidine infiltration 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details   Patients undergoing elective laparoscopic cholecystectomy under general anaesthesia.
 Patients aged 18-60 years.
 Patients of either sex.
 Patients coming under American Society of Anesthesiologists physical status I,II,III 
 
ExclusionCriteria 
Details   Patients allergic to study drugs.
 Patients with acute cholecystitis.
 Patients with severe cardiac, pulmonary and renal diseases.
 Procedure converted to open cholecystectomy.
 Patients in whom abdominal drain is kept.
 Patients unwilling to participate in the study.
 Patients unable to give informed consent.
 Pregnant and lactating women.
 Patients who cannot understand or interpret Numerical Rating Scale for pain.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
a. Magnitude of pain assessed by Numerical Rating Scale.  pain within 24 hours at different time intervals. 
 
Secondary Outcome  
Outcome  TimePoints 
b. Time to first request of analgesia.
c. Analgesic requirement in the first 24 hours post operatively.
d. Incidence of shoulder pain in the study groups.
e. Adverse effects during the study period.
 
b. Time to first request of analgesia.
c. Analgesic requirement in the first 24 hours post operatively.
d. Incidence of shoulder pain in the study groups.
e. Adverse effects during the study period.
 
 
Target Sample Size   Total Sample Size="108"
Sample Size from India="108" 
Final Enrollment numbers achieved (Total)= "102"
Final Enrollment numbers achieved (India)="102" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/02/2019 
Date of Study Completion (India) 31/12/2019 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
none yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

Laparoscopic cholecystectomy as compared to open cholecystectomy is currently the most accepted surgical technique for cholelithiasis because of its advantages like lesser haemorrhage, lesser postoperative pain, better cosmetic results and shorter recovery time.The origin of pain after laparoscopic cholecystectomy is multifactorial - incisional pain (somatic pain), visceral pain (deep intra-abdominal pain), and shoulder pain (presumably referred visceral pain).Pain is the dominating complaint which is most intense on the day of surgery and is the primary reason for prolonged convalescence after laparoscopic cholecystectomy. Also, it has been hypothesized that intense acute pain after laparoscopic cholecystectomy may predict development of chronic pain (e.g., post-laparoscopic cholecystectomy syndrome). So, it is an essential task to provide adequate postoperative analgesia.

Of the multimodal methods to control post-operative pain, intraperitoneal instillation of local anaesthetic agents alone or in combination with opioids, alpha�’2 agonists such as clonidine and dexmedetomidine8 blocks the visceral afferent signals and modifies visceral nociception following laparoscopic cholecystectomy. Both clonidine and dexmedetomidine have been tried as adjuvants with local anaesthetics for intraperitoneal infiltration to provide extended period of post operative analgesia.  However, we have not encountered any human study comparing the effects of clonidine versus dexmedetomidine along with bupivacaine for extended post operative analgesia.

The purpose of the present study is to study and compare the efficacy of  antinociceptive effects of intraperitoneal instillation of dexmedetomidine or clonidine added to bupivacaine for providing extended post operative analgesia in patients undergoing laparoscopic cholecystectomy.



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