| CTRI Number |
CTRI/2025/03/081568 [Registered on: 03/03/2025] Trial Registered Prospectively |
| Last Modified On: |
03/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparision of effect of two additives used along with local anesthetic agent in spinal anaesthesia in patients undergoing lower limb orthopedic surgeries |
|
Scientific Title of Study
|
Comparision of Dexmedetomidine and Clonidine as an adjuvant to intrathecal hyperbarik bupivacaine in patients undergoing lower limb orthopedic surgery: A prospective double blind randomised controlled trial. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
PARVATI |
| Designation |
Post Graduate student |
| Affiliation |
SDM College of Medical Sciences and Hospital |
| Address |
Department of Anaesthesiology SDM College of Medical Sciences and Hospital
Dharwad
Dharwad KARNATAKA 580009 India |
| Phone |
9538189331 |
| Fax |
|
| Email |
parvatisitagi@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr RAVI BHAT |
| Designation |
PROFESSOR |
| Affiliation |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL, DHARWAD |
| Address |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL, DHARWAD, KARNATAKA, INDIA
DEPARTMENT OF ANAESTHESIOLOGY SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL MANJUSHREE NAGAR SATTUR COLONY DHARWAD KARNATAKA Dharwad KARNATAKA 580009 India |
| Phone |
9482181582 |
| Fax |
|
| Email |
kakkodravi@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr RAVI BHAT |
| Designation |
PROFESSOR |
| Affiliation |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL |
| Address |
SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL, DHARWAD DEPARTMENT OF ANAESTHESIOLOGY SDM COLLEGE OF MEDICAL SCIENCES AND HOSPITAL MANJUSHREE NAGAR SATTUR COLONY DHARWAD KARNATAKA Dharwad KARNATAKA 580009 India |
| Phone |
9482181582 |
| Fax |
|
| Email |
kakkodravi@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College Of Medical Sciences And Hospital, Dharwad. |
|
|
Primary Sponsor
|
| Name |
SDM College of Medical Sciences Dharwad |
| Address |
Department of Anaesthesiology SDM College of Medical Sciences and Hospital, DHARWAD, KARNATAKA, INDIA
PINCODE 580009 |
| Type of Sponsor |
Private 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 PARVATI |
SDM college of Medical Sciences and Hospital |
OT number 7 to 8, Main OT complex,SDM Hospital, Sattur, Dharwad.Dharwad, karnataka Dharwad KARNATAKA |
9538189331
parvatisitagi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC-SDM college of Medical of Medical Sciences and Hospital |
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 |
| Comparator Agent |
Bupivacaine with Clonidine |
All members of the group will receive 0.5% Bupivacaine 2.8ml + Clonidine 30mcg intrathecally. VAS score will be assessed upto 24 hours post-operatively |
| Intervention |
Bupivacaine with Clonidine or Bupivacaine with Dexmedetomidine |
GROUP BC + BD : Patients will be administered alternatively with 0.5% Bupivacaine 2.8 ml +Clonidine 30mcg and 0.5% Bupivacaine + Dexmedetomidine 10mcg intrathecally. Post operatively Vas score will be assessed upto 24 hours.Time from study drug injection till first dose of rescue analgesic doses in 24 hours will be recorded. |
| Comparator Agent |
Bupivacaine with Dexmedetomidine |
All members of the group will receive 0.5% Bupivacaine 2.8 ml + dexmedetomidine 10mcg intrathecally. VAS score will be assessed upto 24 hours post-operatively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing surgical procedure for orthopedic lower limb injuries
2. Body mass index less than 30 kg per meter square
3. ASA grade 1 and 2 |
|
| ExclusionCriteria |
| Details |
1 Patients with bronchial asthma, neurologic condition and psychiatric disorder
2. Patients who are on beta blocker therapy or clonidine therapy
3 any contraindications to subarachniod block |
|
|
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 |
| Duration of post operative analgesia |
Time point A: time from study drug injected
Time point B : request for first rescue analgesic post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Post operative visual analogies score |
Time point A: time from study drug injected
Time Pont C : Visual Analogue score more than 4/10 post opratively |
| Adverse effects |
Time point A: time from study drug injection
Time point D: 24 hours from time point A |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
15/03/2025 |
| 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="2" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
After obtaining permission from the institutional ethical committee and written informed consent from patients, patients will be recruited in this prospective double blind randomized controlled trial. Patients will undergo routine pre-anaesthetic examination before considering for surgery. Patients who fulfil the above mentioned inclusion criteria will be enrolled in trial after obtaining a written consent.Patients will be kept nil-per-oral as per ASA( American Society of Anaesiologists )guidelines with oral Pantoprazole 40mg on previous day of surgery. Participants will be familiarized with the recording of post-operative pain using a 10 point visual analogue scale anchored at one end by - no pain at all- and at the other end by - worst pain imaginable. On day of surgery , after re-assessing the patient in pre operative room. Intravenous(iv) line secured and baseline vitals noted. Once patient is shifted to operation theater, iv fluids started, all ASA monitors will be attached and initial readings are noted. Following patient positioning, local skin infiltration using 2ml of lidocaine 2%, 25 G spinal needle will be introduced through L3-L4 interspace under strict aseptic precautions. One of the group will be receiving 3.0 ml volume of 0.5% hyperbaric bupivacaine and 30mcg clonidine intrathecally. Meanwhile, other group will receive 3.0 ml volume of 0.5% hyperbaric bupivacaine and dexmedetomidine 10mcg intrathecally. Drugs will be prepared by anesthesiologist who is not involved in the study so that both patient and investigator will be blinded . Intrathecally injection in both groups will be given over approximately 10 seconds. Immediately after completion of injection, patient will be made to lie supine. The completion of injection will be taken as time zero of induction of anaesthesia. Sensory level will be monitored using pin prick method with 24 gauge hypodermic needle every minute till T10 is achieved. Time when sensory level of T10 is achieved will be noted. The highest sensory level achieved and time taken to achieve that would be noted from time zero. Motor blockade will be assessed every minute using Modified Bromage Scale. Time taken to achieve bromage 3 would be noted. Heart rate, systolic blood pressure, diastolic blood pressure, oxygen saturation will be monitored every 2.5 minutes for initial 30 minutes and later every 15 minutes till end of surgery . Hypotension is defined as fall in blood pressure more than 20% from baseline value and will be treated with ephedrine 6mg. Number of hypotension episodes noted. Post-operatively patient will be kept in recovery room for 2 hours and VAS score will be noted every half an hourly till 2 hours and every 4th hourly till next morning. VAS score more than 4 will be treated with injection tramadol 50mg iv. Total amount of analgesic required will be noted. Post operative nausea vomiting noted and treated with dexamethasone 8mg iv. Incidence of pruitus will be noted and treated with Tab Chlorpheniramine 40mg. Shivering will be noted and treated by applying warm blanket.
|