| CTRI Number |
CTRI/2022/05/042633 [Registered on: 18/05/2022] Trial Registered Prospectively |
| Last Modified On: |
17/05/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
We add either Dexamethasone or Ketamine,with Bupivacaine during spinal anaesthesia and we observe the duration of pain free period after surgery with both added drug and will decide which one give more pain free period after surgery. |
|
Scientific Title of Study
|
Comparison of duration of analgesia after adding intrathecal dexamethasone or ketamine as an adjuvant to bupivacaine in spinal anaesthesia for lower limb orthopaedic surgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sonik G Shah |
| Designation |
Assistant Professor Department of Anesthesia |
| Affiliation |
Dr. N. D. Desai Faculty of Medical Science and Research |
| Address |
201 Suhard 2 Residency Navrang Compound Gotri Road Vadodara
Dr N D Desai Medical College Hospital
Dharmasinh Desai University
College Road Nadiad 387001 Gujarat
Kheda
GUJARAT
390021
India |
| Phone |
9979788588 |
| Fax |
|
| Email |
drsonik@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sonik G Shah |
| Designation |
Assistant Professor Department of Anesthesia |
| Affiliation |
Dr. N. D. Desai Faculty of Medical Science and Research |
| Address |
201 Suhard 2 Residency Navrang Compound Gotri Road Vadodara
Dr N D Desai Medical College Hospital
Dharmasinh Desai University
College Road Nadiad 387001 Gujarat
Kheda
GUJARAT
390021
India |
| Phone |
9979788588 |
| Fax |
|
| Email |
drsonik@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonik G Shah |
| Designation |
Assistant Professor Department of Anesthesia |
| Affiliation |
Dr. N. D. Desai Faculty of Medical Science and Research |
| Address |
201 Suhard 2 Residency Navrang Compound Gotri Road Vadodara
Dr N D Desai Medical College Hospital
Dharmasinh Desai University
College Road Nadiad 387001 Gujarat
Kheda
GUJARAT
390021
India |
| Phone |
9979788588 |
| Fax |
|
| Email |
drsonik@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr N D Desai Faculty of Medical Science and Research |
|
|
Primary Sponsor
|
| Name |
Principal investigator Dr Sonik Shah |
| Address |
Department of Anaesthesia Dr N D Desai faculty of Medical Science and Research College Road Nadiad 387001 Gujarat |
| Type of Sponsor |
Other [] |
|
|
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 Sonik Shah |
Dr N D Desai faculty of medical Science and Research |
Department of anaesthesiology, Operation Theatre no.4,
Dr. N D Desai faculty of medical Science and Research Dharmasinh Desai University College Road Nadiad 387001
Kheda
GUJARAT |
9979788588
drsonik@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: S820||Fracture of patella, (2) ICD-10 Condition: S821||Fracture of upper end of tibia, (3) ICD-10 Condition: S822||Fracture of shaft of tibia, (4) ICD-10 Condition: S823||Fracture of lower end of tibia, (5) ICD-10 Condition: S824||Fracture of shaft of fibula, (6) ICD-10 Condition: S825||Fracture of medial malleolus, (7) ICD-10 Condition: S826||Fracture of lateral malleolus, (8) ICD-10 Condition: S829||Unspecified fracture of lower leg, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bupivacaine,Dexamethasone |
At the time of performing Subarachnoid block Spinal anaesthesia will be given with either 0.5 persent bupivacaine heavy plus 4mg Dexamethasone or 0.5 persent bupivacaine heavy plus Ketamine25mg using standard spinal anaesthesia technique.
Duration of study starts from the point of time spinal anaesthesia given and end at the time rescue dose of analgesia will be given. approximate time will be 3 to 8 hours |
| Comparator Agent |
Bupivacaine,Ketamine |
This study is designed to assess and compare the postoperative analgesic efficacy of Dexamethasone with bupivacaine 0.5 persent heavy group A
and Ketamine with bupivacaine 0.5 persent heavy group B in spinal anaesthesia during and after lower limb orthopaedic surgery.
Duration of study starts from the point of time spinal anaesthesia given and end at the time rescue dose of analgesia will be given. approximate time will be 3 to 8 hours |
| Intervention |
Spinal anaesthesia |
Spinal anaesthesia will be given with either 0.5%bupivacaine heavy+ 4mg Dexamethasone or 0.5% bupivacaine heavy+Ketamine25mg |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria :
1 Age 18-60 years
2 Lower limb Orthopedic surgery
3 ASA physical status 1 or 2
4 Scheduled for planned Surgery on tibia
5 Patients who could understand and rate their pain on VAS scale (0-10) able to provide written consent
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria:
1 Patient’s refusal
2 Emergency surgery
3 Pediatric patient
4 History of Anaphylaxis or Allergy to Local anesthetics
5 History of Bleeding Disorders
6 History of Drug abuse
7 Spine deformity
8 Neurological and cardiac disease
9 Infection at site of Spinal Anesthesia
10 Inability to provide informed consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Patient will be asked for pain and motor recovery every hourly in post operative period in recovery room or in ward, Neurological recovery will also be assessed using Modified Bromage Scale 1 hourly, On patient’s request/VAS 4 and Modified Bromage Scale Grade 5, Rescue analgesia of 50 mg Tramadol in 100 ml NS over 20 min to be given. |
Patient will be asked for pain and motor recovery every hourly in post operative period in recovery room or in ward, Neurological recovery will also be assessed using Modified Bromage Scale 1 hourly, On patient’s request/VAS 4 and Modified Bromage Scale Grade 5, Rescue analgesia of 50 mg Tramadol in 100 ml NS over 20 min to be given. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nausea Vomiting Hypotension Sedation |
One hourly |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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)
|
25/05/2022 |
| 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="10"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
done IJLBPR |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
It is a prospective randomised single blinded control study performed in Operation room. Intervention: At the time of performing Subarachnoid block, Spinal anaesthesia will be given with either 0.5% Bupivacaine heavy + 4mg Dexamethasone or 0.5% Bupivacaine heavy + Ketamine 25 mg using standard spinal anaesthesia technique. Aim: Primary- To prolong analgesic effect after spinal anaesthesia after completion of surgery and to reduce requiremnt of post operative analgesia. Secondary-To compare incidence of complications between two gruops. |