| CTRI Number |
CTRI/2016/09/007245 [Registered on: 07/09/2016] Trial Registered Retrospectively |
| Last Modified On: |
06/09/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
wound injection with bupivacaine and dexmedetomidine compared with placebo for post operative pain relief |
|
Scientific Title of Study
|
post operative analgesic effect of infiltration of bupivacaine and dexmedetomidine in surgical wound- A randomised placebo controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Swati |
| Designation |
Assistant Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anesthesiology,
Indira Gandhi Institute Of Medical Sciences,
Sheikhpura, Patna
Bihar
Patna
BIHAR
80014
India |
| Phone |
|
| Fax |
|
| Email |
deepakswat@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati |
| Designation |
Assistant Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anesthesiology,
Indira Gandhi Institute Of Medical Sciences,
Sheikhpura, Patna
Bihar
Patna
BIHAR
80014
India |
| Phone |
|
| Fax |
|
| Email |
deepakswat@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati |
| Designation |
Assistant Professor |
| Affiliation |
Indira Gandhi Institute of Medical Sciences |
| Address |
Department of Anesthesiology,
Indira Gandhi Institute Of Medical Sciences,
Sheikhpura, Patna
Bihar
Patna
BIHAR
80014
India |
| Phone |
|
| Fax |
|
| Email |
deepakswat@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, Indira Gandhi Institute of Medical Sciences, Sheikhpura
Patna
Bihar-800014 |
|
|
Primary Sponsor
|
| Name |
Indira Gandhi Institute of Medical Sciences Sheikhpura Patna |
| Address |
Department of Anesthesiology,
Indira Gandhi Institute Of Medical Sciences,Sheikhpura, Patna |
| 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 Swati |
Indira Gandhi of Medical Sciences, Sheikhpura, Patna-800014 |
OT no. 7 and 8, Department of Anesthesiology,
Indira Gandhi of Medical Sciences, Sheikhpura, Patna-800014
Patna
BIHAR |
8544413241
deepakswat@yahoo.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 |
those undergoing elective open abdominal surgeries, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
30 ml of 0.25% bupivacaine at the time of wound closure |
to be infiltrated into surgical wound |
| Intervention |
dexmedetomidine 1 microgram/kg with 30 ml of 0.25% bupivacaine at the time of closure. |
to be infiltrated in surgical wound |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
• Age 15 to 60 years.
• ASA grade I &II
• Elective open abdominal surgeries, namely open cholecystectomy, nephrectomy, pyeloplasty.
|
|
| ExclusionCriteria |
| Details |
• Cardiopulmonary diseases
• Hepato-renal insufficiency
• Patients receiving adrenoceptor agonists, antagonists, narcotics, or NSAIDS prior to surgery.
• Raynauds disease
• Morbid obesity
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| pain score by visual analogue score |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| sedation level |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
12/10/2015 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A total of ninety patients will be enrolled, those aged between 15 - 60 years; of ASA status 1 and 2 and undergoing elective abdominal surgeries. They will be randomised into three groups; receiving placebo, bupivacaine (25 ml of 0.25%) and dexmedetomidine (1 mcg/kg dexmedetomidine added to 25 ml of 0.25% bupivacaine) at the end of surgery. pain at rest and on cough will be assessed up to 24 hours after surgery. rescue analgesia will be given with i.v. tramadol 1.5 mg/kg. number of patients requiring rescue analgesia and total consumption of tramadol will be recorded. level of sedation will be assessed using 4 point sedation scale. any adverse effects like nausea/vomiting, hypotension, bradycardia, dry mouth, dizziness, diplopia will be recorded. |