| CTRI Number |
CTRI/2013/07/003841 [Registered on: 25/07/2013] Trial Registered Retrospectively |
| Last Modified On: |
03/06/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To evaluate the effect of local anaesthetic with or without dexmedetomidine for post operative pain relief in laparoscopic gall bladder surgery |
|
Scientific Title of Study
|
Comparative evaluation of ropivaciane with or without dexmedetomidine in ultrasound guided transversus abdominis plane (TAP) block for postoperative analgesia after laparoscopic cholecystectectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR SONU SAMA |
| Designation |
Post Graduate |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE AND HOSPITAL SECTOR-32/B |
| Address |
DEPARTMENT OF ANESTHESIA AND INTENSIVE CARE,LEVEL-5,D BLOCK, GOVERNMENT MEDICAL COLLEGE AND HOSPITAL SECTOR-32/B,
DEPARTMENT OF ANESTHESIA AND INTENSIVE CARE,LEVEL-5,D BLOCK, GOVERNMENT MEDICAL COLLEGE AND HOSPITAL SECTOR-32/B
Chandigarh
CHANDIGARH
160031
India |
| Phone |
7837052889 |
| Fax |
|
| Email |
sonusama9287@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR SANJEEV PALTA |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE AND HOSPITAL SECTOR-32/B |
| Address |
H.No 1151A, sector 32 B, Chandigarh
India
DEPARTMENT OF ANESTHESIA AND INTENSIVE CARE,LEVEL-5,D BLOCK, GOVERNMENT MEDICAL COLLEGE AND HOSPITAL SECTOR-32/B
Chandigarh
CHANDIGARH
160031
India |
| Phone |
9646121523 |
| Fax |
|
| Email |
sanjeev_palta@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR RICHA SAROA |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE AND HOSPITAL SECTOR-32/B |
| Address |
HOUSE NUMBER- 1208 SECTOR-32/B
DEPARTMENT OF ANESTHESIA AND INTENSIVE CARE,LEVEL-5,D BLOCK, GOVERNMENT MEDICAL COLLEGE AND HOSPITAL SECTOR-32/B
Chandigarh
CHANDIGARH
160031
India |
| Phone |
9646121513 |
| Fax |
|
| Email |
richajayant@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Director principal, government medical college and hospital sec- 32 chandigarh |
|
|
Primary Sponsor
|
| Name |
Director principal |
| Address |
Government medical college and hospital sec-32 chandigarh |
| Type of Sponsor |
Government medical college |
|
|
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 |
| DR SANJEEV PALTA |
Department of anaesthesia |
D-block,level-5,GOVERNMENT MEDICAL COLLEGE AND HOSPITAL SECTOR - 32/B
Chandigarh
CHANDIGARH |
9646121523
sanjeev_palta@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTTEE Academics branch government medical college and hospital sec 32 chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Cholelithiasis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
To evaluate the relative efficacy of ropivacaine (0.375%) with dexmedetomidine (1mcg/kg) in ultrasound guided transversus abdominis plane (TAP) block for postoperative analgesia after laparoscopic cholecystectomy. |
To evaluate the relative efficacy of ropivacaine (0.375%)(maximum dose 3mg/kg) with dexmedetomidine(1mcg/kg)(total volume used 20ml on each side) in ultrasound guided transversus abdominis plane (TAP) block for postoperative analgesia after laparoscopic cholecystectomy.Patients followed up for 24hrs for pain relief |
| Intervention |
To evaluate the relative efficacy of ropivacaine(0.375%) in USG TAP block for post opeartive pain relief in patients scheduled for laparoscopic cholecystectomy |
To evaluate the relative efficacy of ropivacaine(0.375%)(maximum dose 3mg/kg,volume used 20ml on each side) in ultrasound guided transversus abdominis plane (TAP) block for postoperative analgesia after laparoscopic cholecystectomy.Patients followed up for 24hrs for pain relief. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
• ASA physical status I-II
• Age 18-65 yrs
• Body weight 50-75 kg of either sex
BODY MASS INDEX ( > 18 - < 25 )
|
|
| ExclusionCriteria |
| Details |
• History of relevant drug allergy
• Age < 18yrs or >65yrs
• History of psychiatric illness ,
substance abuse ,or medical therapies
resulting in tolerance to opioids
• Acute cholecystitis or pancreatitis
• Severe cardiovascular , respiratory ,
metabolic, or neurological disease
• Surgery requiring postoperative
intraabdominal drainage
• Pregnancy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the relative efficacy of ropivacaine with or without dexmedetomidine in ultrasound guided transversus abdominis plane (TAP) block for postoperative analgesia after laparoscopic cholecystectomy |
10 min, 30 min, 1 hr, 4hr, 8hr, 12 hr and 24 hrs in the post operative period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To calculate the total dose of rescue analgesic over 24 hours in both the groups, and to
evaluate postoperative nausea and vomiting and to calculate the dose of antiemetic over
24 hours.
To note any side effects pertaining to the drugs being used
|
Over 24 hrs |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/12/2011 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="11"
Days="20" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Ultrasound guided Transversusabdominis plane (TAP) block is a regional analgesic technique that blocks abdominal neural afferents by introducing local anesthetic into the neurofascial plane between the internal oblique and the transversus abdominis muscles thereby reducing the postoperative pain of abdominal surgeries.Various local anesthetic agents including ropivacaine an S- enantiomer of bupivacaine have been used to provide effective and adequate postoperative analgesia in TAP block. Dexmedetomidine, the pharmacologically active d- isomer of medetomidine is a highly specific and selective α2adrenoreceptor agonist having both central as well as peripheral actions.
The present study is aimed at comparative evaluation and relative efficacy of ropivacaine(0.375%) and ropivacaine(0.375%) with dexmedetomidine(1mcg/kg) in ultrasound guided TAP block for post operative analgesia in laparoscopic cholecystectomy.
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