| CTRI Number |
CTRI/2024/03/064566 [Registered on: 20/03/2024] Trial Registered Prospectively |
| Last Modified On: |
26/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two local anaesthetic drugs (Levobupivacaine with dexmedetomidine and Ropivacaine with dexmedetomidine) for ultrasound guided supraclavicular nerve block (brachial plexus block): a randomised controlled trial. |
|
Scientific Title of Study
|
Comparison of Levobupivacaine and dexmedetomidine versus Ropivacaine and dexmedetomidine for ultrasound guided supraclavicular brachial plexus block: a randomised control 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 |
Sofia Batool |
| Designation |
Associate Professor |
| Affiliation |
Sikkim Manipal Institute of Medical Sciences |
| Address |
Department of Anaesthesia, Level-6, Central Referral Hospital. Sikkim Manipal Institute of Medical Sciences, 5th Mile, Tadong. Gangtok.
East SIKKIM 737102 India |
| Phone |
9733005809 |
| Fax |
|
| Email |
sofia.b@smims.smu.edu.in |
|
Details of Contact Person Scientific Query
|
| Name |
Sofia Batool |
| Designation |
Associate Professor |
| Affiliation |
Sikkim Manipal Institute of Medical Sciences |
| Address |
Department of Anaesthesia, Level-6, Central Referral Hospital. Sikkim Manipal Institute of Medical Sciences, 5th Mile, Tadong. Gangtok.
SIKKIM 737102 India |
| Phone |
9733005809 |
| Fax |
|
| Email |
sofia.b@smims.smu.edu.in |
|
Details of Contact Person Public Query
|
| Name |
Sofia Batool |
| Designation |
Associate Professor |
| Affiliation |
Sikkim Manipal Institute of Medical Sciences |
| Address |
Department of Anaesthesia, Level-6, Central Referral Hospital. Sikkim Manipal Institute of Medical Sciences, 5th Mile, Tadong. Gangtok.
SIKKIM 737102 India |
| Phone |
9733005809 |
| Fax |
|
| Email |
sofia.b@smims.smu.edu.in |
|
|
Source of Monetary or Material Support
|
| Sikkim Manipal Institute of Medical Sciences, 5th Mile, Tadong, Gangtok. |
|
|
Primary Sponsor
|
| Name |
Dr Sofia Batool |
| Address |
Department of Anaesthesia, Level-6, Central Referral Hospital. Sikkim Manipal Institute of Medical Sciences. 5th Mile, Tadong. Gangtok. 737102. |
| 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 Sofia Batool |
Sikkim Manipal Institute of Medical Sciences |
5th Mile, Tadong. Gangtok. 737102. East SIKKIM |
9733005809
sofia.b@smims.smu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMIMS Institution Ethics Committee |
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 |
Levobupivacaine with Dexmedetomidine |
24 ml solution of 0.5% Levobupivacaine and 50 mcg of Dexmedetomidine will be used to block brachial plexus in supraclavicular region under ultrasound guidance |
| Comparator Agent |
Ropivacaine with Dexmedetomidine |
24 ml solution of 0.5% Ropivacaine and 50 mcg of Dexmedetomidine will be used to block brachial plexus in supraclavicular region under ultrasound guidance |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. American society of Anaesthesiology (ASA) grade I and II
2. Elective upper limb surgery lasting more than 30 minutes |
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Onset and duration of sensory and motor block
2. Numerical Rating Scale (NRS) for post-operative analgesia |
1. For onset and duration of block: every 5 minutes for 30 minutes
2. For Numeric rating scale: every hour following surgery till the request of first analgesic |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Ramsay sedation score
2. Hemodynamic parameters (pulse rate, blood pressure, oxygen saturation of blood) |
Every 5 minutes till the end of surgery |
|
|
Target Sample Size
|
Total Sample Size="34" Sample Size from India="34"
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)
|
01/04/2024 |
| 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="0" Months="4" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Background Supraclavicular brachial plexus block is popular and widely used nerve block technique for anaesthesia and analgesia for upper limb surgeries. Lidocaine and bupivacaine are most often used local anaesthetic agents. Newer drugs are safe and have less systemic side effects. The purpose of the present study is to to find a local anaesthetic agent with maximum efficacy and minimum side effects for upper extremity blocks.
Research Question Is Levobupivacaine with dexmedetomidine better than Ropivacaine with dexmedetomidine for peripheral nerve blocks?
Objectives Primary objectives 1. To compare the onset and duration of sensory and motor block between levobupivacaine with dexmedetomidine and ropivacaine with dexmedetomidine 2. To compare post operative analgesia between levobupivacaine with dexmedetomidine and ropivacaine with dexmedetomidine
Secondary objectives 1. To compare the Ramsay sedation score between the two groups 2. To compare the hemodynamic parameters between two groups
Hypothesis Null hypothesis (H0): There is no difference between the two drugs (levobupivacaine with dexmedetomidine and ropivacaine with dexmedetomidine) for onset of action, duration of action and postoperative analgesia. Alternate hypothesis (H1): Levobupivacaine with dexmedetomidine is better than ropivacaine with dexmedetomidine for onset of action, duration of action and postoperative analgesia.
Methodology Inclusion criteria 1. American society of Anaesthesiology Grade (ASA) - I, II 2. Age between 18 years and 65 years 3. Elective upper limb surgery lasting more than 30 mins
Exclusion criteria 1. Uncontrolled hypertension, diabetes mellitus, arrhythmias, 2. Heart failure, renal failure, liver failure 3. Seizure disorder 4. Bleeding/ coagulation disorder 5. Pre-existing peripheral neuropathy 6. Known hypersensitivity to local anaesthetics. 7. BMI >30 8. Local skin infection 9. Pregnancy and lactating mothers 10. Bradycardia (heart rate <50 /min)
Procedure standardization Patients will be randomized using simple lottery (sealed envelope) technique. Once patients received in preoperative area, patients will be divided into two groups; Group L and Group R based on envelope selected by them. Envelopes would contain drug details and dosage to be prepared by OT technicians. The drugs will be prepared as follows:
Group L: Levobupivacaine 0.5% (24 ml) with dexmedetomidine 50 mcg (1 ml) Group R: Ropivacaine 0.5% (24 ml) with dexmedetomidine 50 mcg (1 ml)
Total volume of the drug will be 25ml for all patients. Patient will be taken to the operation theatre; vitals will be monitored, and supraclavicular block performed under all aseptic precautions under ultrasound guidance by an anaesthesiologist who will be unaware of the drug composition. Once the study drug is delivered, following parameters will be assessed and noted.
1. Time of onset of sensory and motor block 2. Time when complete sensory and motor block is achieved
After achieving complete sensory and motor block patient is proceeded for surgery. Only successful block cases will be taken for study. Throughout intraoperative period vitals are monitored .Degree of sedation will be monitored at all intervals as that of vital parameters. On arrival in the postanaesthetic care unit, pain scoring will be assessed using Numeric Rating Scale (NRS) on movement of operated arm. NRS on movement will be assessed hourly following surgery till the request of first analgesic. Postoperative vitals will be assessed every hour till the regression of block. Any side effects such as nausea, vomiting, and sedation will be noted. Postoperative sedation score will be assessed hourly till the regression of block. Data analysis The data will be tabulated and analysed using Microsoft© Excel© 2013 and IBM© SPSS©-21 software. The categorical data will be analysed using χ2 and Fisher Exact test and continuous data using student t-test and ANOVA. |