| CTRI Number |
CTRI/2019/03/018324 [Registered on: 29/03/2019] Trial Registered Prospectively |
| Last Modified On: |
19/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
A study comparing the action of injection clonidine given through spinal and intravenous routes for reducing the shoulder pain caused by insufflation of the abdomen with carbondioxide during elective laparoscopic operation. |
|
Scientific Title of Study
|
A comparison between intrathecal clonidine and intravenous clonidine for reducing the pneumoperitoneum induced shoulder pain for laparoscopic surgeries under subarachnoid block |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Madhava ReddyR |
| Designation |
PROFESSOR |
| Affiliation |
KIMS hospital, Bangalore |
| Address |
Department of Anesthesiology, KIMS hospital, Bangalore.
Bangalore
KARNATAKA
560004
India |
| Phone |
9379094790 |
| Fax |
|
| Email |
madhavareddy.r@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Madhava ReddyR |
| Designation |
PROFESSOR |
| Affiliation |
KIMS hospital, Bangalore |
| Address |
Department of Anesthesiology, KIMS hospital, Bangalore.
Bangalore
KARNATAKA
560004
India |
| Phone |
9379094790 |
| Fax |
|
| Email |
madhavareddy.r@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Komala B |
| Designation |
Post graduates |
| Affiliation |
KIMS hospital, Bangalore |
| Address |
KIMS resident quarters, KIMS Hospital VV Puram, Bangalore.
KIMS Resident quarters, KIMS hospital, Bangalore
Bangalore
KARNATAKA
560004
India |
| Phone |
07204856186 |
| Fax |
|
| Email |
komalaharini@gmail.com |
|
|
Source of Monetary or Material Support
|
| self Dr.MadhavaReddy.R Professor, department of anesthesiology, KIMS hospital, Banglore. 560004 |
|
|
Primary Sponsor
|
| Name |
DrMadhavaReddyR |
| Address |
Department of anesthesiology, KIMS hospital VV puram Bangalore |
| Type of Sponsor |
Other [self sponsor] |
|
|
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 |
| DrMadhav Reddy R |
KIMS hospital |
Dr.Madhav Reddy.R, Department of Anesthesiology, VV puram Bangalore, 560004
Bangalore
KARNATAKA |
9379094790
madhavareddy.r@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: K358||Other and unspecified acute appendicitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intrathecal clonidine |
Intrathecal clonidine for reducing the pneumoperitoneum induced shoulder pain in laparoscopic surgeries under subarachnoid block. 3ml of 0.5% hyperbaric bupivacaine plus 1μ/kg of clonidine to a volume of 3.5ml intrathecally and 10ml of normal saline intravenously |
| Comparator Agent |
Intravenous clonidine |
Intravenous clonidine for reducing the pneumoperitoneum induced shoulder pain in laparoscopic surgeries under sub arachnoid block. 3ml of 0.5% hyperbaric bupivacaine plus 0.5ml of normal saline intrathecally and 1μ/kg of clonidine diluted in 10ml of normal saline intravenously |
| Intervention |
spinal anaesthesia in laparoscopic surgeries |
Comparing intravenous clonidine and Intrathecal clonidine for reducing the pneumoperitoneum induced shoulder pain in laparoscopic surgeries under sub arachnoid block. Intervention done before the start of surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
ASA physical status 1 and 2 of either sex.
Age between 18 and 50 years.
Scheduled for elective laparoscopic surgery |
|
| ExclusionCriteria |
| Details |
Emergency laparoscopic surgery
Any contra-indications for spinal anaesthesia
Weight > 75kg |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| comparing the effect of clonidine in reducing shoulder pain in laparoscopic surgeries by intrathecal and intravenous route under spinal anaesthesia |
The outcome is assessed during intraoperative period and post operative period in both the groups. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/04/2019 |
| Date of Study Completion (India) |
23/08/2019 |
| 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
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
By using spinal anesthesia we can avoid general anesthesia related complications, and also polypharmacy. Clonidine as an adjuvant to local anesthetic in spinal anesthesia will reduce intra and post-operative pain which is both beneficial ans cost effective for the patients. Hence in this study we are going to compare the use two different routes of clonidine administration for patients undergoing laparoscopic surgery under spinal anaesthesia. |