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
|
|
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
|
|
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.
|