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
|
|
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. |