| CTRI Number |
CTRI/2012/12/003258 [Registered on: 26/12/2012] Trial Registered Retrospectively |
| Last Modified On: |
24/12/2012 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to compare the effect of clonidine administration by two different routes, intravenous and surgical site infiltration,on pain after gall bladder surgery |
|
Scientific Title of Study
|
Comparison of postoperative analgesic effect of clonidine through intravenous administration versus wound infiltration in patients undergoing open cholecystectomy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neerja Bharti |
| Designation |
Additional professor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Department of Anesthesia, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9915575145 |
| Fax |
|
| Email |
bhartineerja@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sujana Dontukurthy |
| Designation |
Ex-senior resident |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Department of Anesthesia, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9915575145 |
| Fax |
|
| Email |
sujanad7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Neerja Bharti |
| Designation |
Additional professor |
| Affiliation |
PGIMER, Chandigarh |
| Address |
Department of Anesthesia, PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9915575145 |
| Fax |
|
| Email |
bhartineerja@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia, Nehru hospital |
|
|
Primary Sponsor
|
| Name |
Director |
| Address |
Post Graduate Institute of Medical Institution and Research, Chandigarh |
| 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 |
| Neerja Bharti |
Department of Anesthesia |
Nehru Hospital,PGIMER
Sector 12
Chandigarh
CHANDIGARH |
9915575145
bhartineerja@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Review Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Post surgical pain, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
1.Intravenous clonidine OR
2.Clonidine subcutaneous inflitration. |
1. 3 mcg/kg intravenous clonidine diluted in 1 ml normal saline after gall bladder removal
2. 3 mcg/kg subcutaneous clonidine with 30 ml of 0.25% bupivacaine during skin closure |
| Comparator Agent |
Normal saline (placebo) |
IV normal saline, 1 ml, after removal of gall bladder |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients posted for elective open cholecystectomy under general anesthesia |
|
| ExclusionCriteria |
| Details |
Patients with ASA physical status 3 or 4, Patients with morbid obesity, patients receiving adrenoceptor agonist, antagonist or narcotics |
|
|
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 |
| Postoperative pain and analgesic requirement |
24 postoperative hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Side effects, like sedation, nausea-vomiting, hypotension and bradycardia
Patients satisfaction score |
24 postoperative hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
09/09/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="15" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This randomized double- blind study was conducted to compare the postoperative analgesic effect of clonidine when administered intravenously or in wound infiltration with bupivacaine. 60 adult patients of ASA grade I-II undergoing elective open cholecystectomy were randomly allocated into three groups. Group 1 (control group) patients received wound infiltration with 30 ml 0.25% bupivacaine at the end of surgery. Group 2 patients received 3 mcg/kg clonidine IV plus wound infiltration with bupivacaine, while group 3 patients received 3 mcg/kg clonidine in would infiltration with bupivacaine. Postoperative analgesia was provided with intravenous diclofenac 8 hourly and morphine on demand. The postoperative pain, number of patients requiring rescue analgesia and total morphine consumption during 24 postoperative hours was recorded. Patients were observed for any adverse effects like excessive sedation, nausea-vomiting, hypotension and bradycardia.
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