| CTRI Number |
CTRI/2024/07/070200 [Registered on: 08/07/2024] Trial Registered Prospectively |
| Last Modified On: |
08/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the duration of pain relief with clonidine and morphine added to local anaesthetic drug Bupivacaine in spinal anaesthesia for patients undergoing vaginal hysterectomy. |
|
Scientific Title of Study
|
Randomized, double blinded clinical trial to evaluate efficacy of intrathecal clonidine and intrathecal morphine as adjuvants to hyperbaric bupivacaine in spinal anaesthesia for patients undergoing vaginal hysterectomy. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rajesh Ravi |
| Designation |
Junior Resident |
| Affiliation |
Christian Medical College |
| Address |
Department of Anaesthesiology, Christian Medical College, Vellore,
Tamilnadu, India
Vellore
Vellore TAMIL NADU 632004 India |
| Phone |
9486027872 |
| Fax |
|
| Email |
dr.rrajesh92@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anita Shirley |
| Designation |
Professor |
| Affiliation |
Christian Medical College |
| Address |
Department of Anaesthesiology, Christian Medical College, Vellore,
Tamilnadu, India
Vellore
Vellore TAMIL NADU 632004 India |
| Phone |
7358377164 |
| Fax |
|
| Email |
anjeyanth@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Anita Shirley |
| Designation |
Professor |
| Affiliation |
Christian Medical College |
| Address |
Department of Anaesthesiology, Christian Medical College, Vellore,
Vellore TAMIL NADU 632004 India |
| Phone |
7358377164 |
| Fax |
|
| Email |
anjeyanth@gmail.com |
|
|
Source of Monetary or Material Support
|
| Fluid research grant , Christian medical college , Vellore -632004. |
|
|
Primary Sponsor
|
| Name |
Rajesh Ravi |
| Address |
Department of Anaesthesiology, Christian Medical College, Vellore,
Tamilnadu, India
Vellore
TAMIL NADU
632004
India |
| Type of Sponsor |
Other [Self] |
|
|
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 Rajesh Ravi |
Christian Medical College |
Operating room,
Department of
Anaesthesiology. Vellore TAMIL NADU |
9486027872
dr.rrajesh92@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Insstitutional Review Board and Ethics Committee of CMC Vellore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Clonidine |
Dose - 0.1 micrograms per kilogram of body weight
Route - Intrathecal
Frequency - once before the start of surgery and will be observed for 24 hours |
| Comparator Agent |
Morphine |
Dose - 1 to 2 micrograms per kilogram of body weight
Route - Intrathecal
Frequency - once before the start of surgery and will be observed for 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
undergoing Vaginal hysterectomy under spinal anesthesia |
|
| ExclusionCriteria |
| Details |
Patients who have contraindications for regional anaesthesia will be excluded from the study |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the duration of postoperative analgesic effect of intrathecal clonidine and morphine when used as adjuvants to hyperbaric bupivacaine in spinal anaesthesia |
24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare postoperative pain scores in both groups.
2. To compare side effects like sedation, bradycardia, hypotension, urinary retention, nausea, vomiting, Itching, dry mouth and post operative shivering.
3. Time to regression of motor or sensory block
4. Time to first oral intake
5. Patient satisfaction scores
|
24 hours |
|
|
Target Sample Size
|
Total Sample Size="140" Sample Size from India="140"
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)
|
19/07/2024 |
| 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="0" Months="8" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Healthy female patients, 18 years of age and older, who are undergoing vaginal hysterectomy under spinal anesthesia will be included in the study after IRB approval and CTRI registration. Patients will be informed about the anesthesia plan and will provide written informed consent a day before the surgery. Patients with contraindications for regional anesthesia will be excluded from the study. The participants will be randomly assigned to two groups. The control group will receive a subarachnoid block with heavy Bupivacaine 0.5% and intrathecal morphine 2 mcg/kg, according to the standard of care in our institution. Patients in the study group will receive a subarachnoid block with heavy Bupivacaine 0.5% and intrathecal clonidine 1 mcg/kg. Both groups will receive the same intraoperative monitoring of vital signs, IV fluids, and anti-emetic medications. The duration of analgesic effect will be measured from the time of spinal administration to the first analgesic request in the postoperative period. The time to regression of motor and sensory blocks will be assessed. Postoperative pain scores, side effects, time to first oral intake, and patient satisfaction scores will be recorded for both groups. |