| CTRI Number |
CTRI/2024/04/066084 [Registered on: 22/04/2024] Trial Registered Prospectively |
| Last Modified On: |
18/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparision of two different doses of buprenorphine as add on to levobupivacaine in arthroscopic lower limb surgeries:A randomized double-blind study |
|
Scientific Title of Study
|
Comparision of two different doses of intrathecal buprenorphine as adjuvants to levobupivacaine in arthroscopic lower limb surgeries:A randomized double-blind study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vivek Sharma |
| Designation |
Academic JR |
| Affiliation |
All IndiaAll India Institute of Medical Sciences,Gorakhpur |
| Address |
Department of Anaesthesiology AIIMS Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9807086720 |
| Fax |
|
| Email |
v.shrm786@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijeta Bajpai |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences,Gorakhpur |
| Address |
Department of Anaesthesiology AIIMS Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9451614415 |
| Fax |
|
| Email |
drvijeta86gsvm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vivek Sharma |
| Designation |
Academic JR |
| Affiliation |
All IndiaAll India Institute of Medical Sciences,Gorakhpur |
| Address |
Department of Anaesthesiology AIIMS Gorakhpur
Gorakhpur
UTTAR PRADESH
273008
India |
| Phone |
9807086720 |
| Fax |
|
| Email |
v.shrm786@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences Gorakhpur India 273008 |
|
|
Primary Sponsor
|
| Name |
Dr Vivek Sharma |
| Address |
Department of Anaesthesiology AIIMS Gorakhpur,contact no. 9807086720 email id-v.shrm786@gmail.com |
| Type of Sponsor |
Other [other(self)] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| not applicable |
not applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| dr Vivek Sharma |
All India Institute of Medical Sciences |
Department of anaesthesiology pain and critical care medicine
Gorakhpur
UTTAR PRADESH |
9807086720
v.shrm786@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethics Committee AIIMS GORAKHPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M968||Other intraoperative and postprocedural complications and disorders of musculoskeletal system, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group L-0.5 % Levobupivacaine with Normal Saline |
Patients will receive 0.5% hyperbaric levobupivacaine 2.8 ml with 0.2 ml 0.9% in subarachnoid space through spinal needle intraoperatively.
|
| Intervention |
Group LB1-Group L-0.5 % Levobupivacaine with 60 mcg inj Buprenorphine |
Patients will receive 0.5% hyperbaric levobupivacaine 2.8 ml with 60 mcg in subarachnoid space through spinal neddle intraoperatively. |
| Intervention |
Group LB2-Group L-0.5 % Levobupivacaine with 75 mcg inj Buprenorphine |
Patients will receive 0.5% hyperbaric levobupivacaine 2.8 ml with 75 mcg in subarachnoid space through spinal needle intraoperatively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Class I/II undergoing arthroscopic lower limb surgeries under subarachnoid block |
|
| ExclusionCriteria |
| Details |
o H/o hypersensitivity reaction to local anaesthetics
o Uncontrolled hypertension, diabetes mellitus and morbid obesity
o Contraindication to spinal anaesthesia.
o History of alcohol or drug abuse and patients on Chronic opioid
o Patient not giving consent
o Patients undergoing emergency surgery
o Pregnant and lactating females
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare duration of analgesia- Time from intrathecal injection till administration of first rescue analgesic for 24 hours |
To compare duration of analgesia- Time from intrathecal injection till administration of first rescue analgesic for 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1-To compare the time taken for onset of sensory block
Time taken from the end of injection to loss of pin prick sensation at T10 dermatome
2-To compare the time taken for onset of motor block -The time taken to achieve a score of 2 on the modified Bromage scale. [9]
3-To compare the duration of sensory block- It will be two-segment regression time from highest level of sensory blockade.
4-To compare the duration of motor block- The duration of the motor block will be defined as the time interval between the onset of motor block (modified Bromage scale 2) to the achievement of modified Bromage scale 6 after the surgery.
Safety outcome- Recording and reporting of adverse events(nausea,vomiting,respiratory depression) will be collected
|
intraoperative and postoperative |
|
|
Target Sample Size
|
Total Sample Size="96"
Sample Size from India="96"
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 4 |
|
Date of First Enrollment (India)
|
30/04/2024 |
| 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="1"
Months="6"
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
|
This study is a randomized,double blind,parallel group,comparing two different doses of intrathecal buprenorphine as adjuvants to levobupivacaine for duration of analgesia in 96 patients admitted at AIIMS Gorakhpur for elective Arthroscopic lower limb surgeries.The primary outcome measures will be to assess duration of analgesia in patients who received two different doses of buprenorphine as adjuvants to levobupivacaine. Secondary outcomes are to compare the time taken for onset of sensory block, motor block and duration of sensory block and motor block. Safety outcome will be recording and reporting of adverse events. |