| CTRI Number |
CTRI/2022/04/041666 [Registered on: 05/04/2022] Trial Registered Prospectively |
| Last Modified On: |
04/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to compare the duration of pain free period after surgery when Butorphanol and Tramadol given with Levobupivacaine in brachial plexus block |
|
Scientific Title of Study
|
Efficacy of Butorphanol and Tramadol as adjuvant to Levobupivacaine for postoperative analgesia in brachial plexus block- A randomized double blind study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ravi Chaudhari |
| Designation |
PG Student |
| Affiliation |
Pt JNM Medical College Raipur |
| Address |
Department of Anaesthesiology Pt JNM Medical College Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
8308422897 |
| Fax |
|
| Email |
ravichaudharicc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jaya Lalwani |
| Designation |
Professor |
| Affiliation |
Pt JNM Medical College Raipur |
| Address |
Department of Anaesthesiology Pt JNM Medical College Raipur
Raipur
CHHATTISGARH
492001
India |
| Phone |
9300224989 |
| Fax |
|
| Email |
jayalalwani2020@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jaya Lalwani |
| Designation |
Professor |
| Affiliation |
Pt JNM Medical College Raipur |
| Address |
Department of Anaesthesiology Pt JNM Medical College Raipur
CHHATTISGARH
492001
India |
| Phone |
9300224989 |
| Fax |
|
| Email |
jayalalwani2020@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Bhimrao Ambedkar memorial hospital Raipur |
|
|
Primary Sponsor
|
| Name |
Dr Jaya Lalwani |
| Address |
Department of Anaesthesiology Pt JNM Medical College Raipur |
| 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 Ravi Chaudhari |
Dr Bhimrao Ambedkar Memorial Hospital RaipurPt |
Department of Anaesthesiology Pt. JNM Medical College, Jail Road, Raipur
Raipur
CHHATTISGARH |
8308422897
ravichaudharicc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Pt. JNM Medical College Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S529||Unspecified fracture of forearm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inj Butorphanaol |
Butorphanol 2mg with 20 ml of 0.5% Levobupivacaine in brachial plexus block |
| Intervention |
Inj Tramadol |
Tramadol 100 mgwith 20 ml of 0.5% Levobupivacaine in brachial plexus block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. ASA grade I to III
2. Patients undergoing elective below elbow upper limb surgery under ultra sound guided supraclavicular brachial plexus block |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Local infection at injection site
3. Failure of block
4. Any bleeding disorder and patient on anticoagulants
5. Allergy to study drugs
6. Severe respiratory, renal and liver disorder
7. Glucose intolerance and diabetic patient
8. Neurological deficit involving brachial plexus
9. Morbidly obese
10. Pregnant women
11. Drug abuse |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Duration of postoperative analgesia
|
First 24 hours of postoperative period
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
⮚ Assessment of pain using VAS
⮚ Onset of sensory and motor blockade
⮚ Duration of sensory and motor blockade
⮚ Adverse effects– CNS toxicity [convulsion, coma], CVS toxicity [tachycardia, arrhythmias], respiratory depression, nausea, vomiting, allergic reactions, pneumothorax, Horners syndrome and recurrent laryngeal nerve block.
|
First 24 hours of postoperative period
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
11/04/2022 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective observational study to see the duration of postoperative analgesia when Butorphanol and Tramadol given with Levobupivacaine for brachial plexus block in patients undergoing below elbow upper limb surgery aged 18 to 65 years with ASA grade I to III. It will be conducted at single centre in India. The primary outcome will be duration of postoperative analgesia and secondary outcomes will be assessment of pain using VAS, onset and duration of sensory and motor blockade and monitoring associated symptoms like allergic reactions, nausea, vomiting, pneumothorax, Horner’s syndrome. |