CTRI Number |
CTRI/2020/05/025082 [Registered on: 08/05/2020] Trial Registered Prospectively |
Last Modified On: |
06/05/2020 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Comparison of the effect of two different types of drugs when mixed to the local anaesthetics for upper limb block |
Scientific Title of Study
|
A comparative study of the effect of Dexmedetomidine and Nalbuphine as an adjuvant to Levobupivacaine in ultrasound guided supraclavicular brachial plexus block: A prospective 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 |
Jyoti Mala |
Designation |
Senior Resident |
Affiliation |
INDIRA GANDHI INSTITUTE OF MEDICAL COLLEGE |
Address |
Department of Anaesthesiology and Critical care, First floor, IGIMS, Sheikhpura, Patna Department of Anaesthesiology and Critical care, First floor, IGIMS, Sheikhpura, Patna Patna BIHAR 800014 India |
Phone |
9955882635 |
Fax |
|
Email |
drmalajyoti17@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Jyoti Mala |
Designation |
Senior Resident |
Affiliation |
INDIRA GANDHI INSTITUTE OF MEDICAL COLLEGE |
Address |
Department of Anaesthesiology and Critical care, First floor, IGIMS, Sheikhpura, Patna Department of Anaesthesiology and Critical care, First floor, IGIMS, Sheikhpura, Patna Patna BIHAR 800014 India |
Phone |
9955882635 |
Fax |
|
Email |
drmalajyoti17@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Jyoti Mala |
Designation |
Senior Resident |
Affiliation |
INDIRA GANDHI INSTITUTE OF MEDICAL COLLEGE |
Address |
Department of Anaesthesiology and Critical care, First floor, IGIMS, Sheikhpura, Patna Department of Anaesthesiology and Critical care, First floor, IGIMS, Sheikhpura, Patna Patna BIHAR 800014 India |
Phone |
9955882635 |
Fax |
|
Email |
drmalajyoti17@gmail.com |
|
Source of Monetary or Material Support
|
Jyoti Mala, Department of Anaesthesiology and Critical care, First floor, IGIMS, Sheikhpura, Patna PIN- 800014 |
|
Primary Sponsor
|
Name |
Jyoti Mala |
Address |
C/O - Dr. Jyoti Mala, Senior Resident, Department of Anaesthesiology and Critical care, First floor, IGIMS, Sheikhpura, Patna, PIN- 800014 |
Type of Sponsor |
Government 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 Arvind Kumar |
Indira Gandhi Institute of Medical Sciences |
Department of Orthopediocs and Surgery, Ward, Bed no 1-70, IGIMS, Patna Patna BIHAR |
9534870908
arvind007kumar@yahoo.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Indira Gandhi Institute of Medical Sciences Ethical Committee |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: M00-M99||Diseases of the musculoskeletal system and connective tissue, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Effect of Dexmedetomidine as an adjuvant to Levobupivacaine in ultrasound guided supraclavicular brachial plexus block |
One group will receive 20 ml of 0.5% levobupivacaine with 1 μg/kg dexmedetomidine diluted to the volume of 10 ml NS, making total volume of 30ml.
Ultrasound guided supraclavicular plexus block will be performed by placing the patient in the supine position with their head turned in the direction opposite the interventional side. Subsequently, the probe of the ultrasound equipment wrapped in sterile cover will placed on supraclavicular fossa to locate the subclavian artery and brachial plexus cluster. After local anesthetic infiltration, a 50 mm 22 G insulated short beveled stimulation needle will be inserted towards the brachial plexus cluster from lateral to medial in the long axis of the ultrasound beam after locating the subclavian artery and brachial plexus cluster. Once the needle tip reached the brachial plexus cluster on the ultrasound image,30 ml of drug will be injected as appropriate for the group of study.
|
Intervention |
Effect of Nalbuphine as an adjuvant to Levobupivacaine in ultrasound guided supraclavicular brachial plexus block |
Another group will receive 20 ml of 0.5% levobupivacaine with 1ml(10mg)of Nalbuphine diluted to the volume of 10 ml NS making total volume of 30ml. Ultrasound guided supraclavicular plexus block will be performed as mentioned above and 30 ml of drug will be injected as appropriate for the group of study. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
50.00 Year(s) |
Gender |
Both |
Details |
1. Patients posted for upper limb surgery of either side
2. Patients of ASA physical status 1 & 2
3. Patients between 18-50 years of age of either sex
4. Patients able to comprehend and willing to participate
|
|
ExclusionCriteria |
Details |
1. Patient’s refusal to participate
2. Patients of ASA physical status3 & 4
3. Any allergy to local anaesthetics
4. Coagulation disorders
5. Infection at the site of intervention
6. History of any underlying cardiac, renal or hepatic dysfunction
•Pregnant patient
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
On-site computer system |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
1. Onset of motor block
2. Onset of sensory block
3. Duration of analgesia
|
3 months
|
|
Secondary Outcome
|
Outcome |
TimePoints |
1. Hemodynamic stability
2. Side effects
|
3 months |
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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 |
Date of First Enrollment (India)
|
11/05/2020 |
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="3" 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)?
|
Brief Summary
|
Supraclavicular brachial plexus blockade is the common approach to provide surgical anesthesia of upper limb, was first described by Kulenkampff in 1911.(1) It is an efficient regional anesthetic technique for upper limb surgeries. Which is a reliable, alternative to general anesthesia for certain group of patients as it is devoid of undesired effects of general anesthesia and stress of laryngoscopy. The postoperative period is also free from pain, nausea, vomiting, and respiratory depression. Adjuvants are added to local anaesthetics to improve various block characteristics in terms of onset of action ,duration of analgesia with lesser adverse effect. Various study has been done using different types of adjuvants in different combination of local anaesthetics for various nerve blocks. In our study we will use levobupivacaine LA because it is relatively safe in terms of less cardiac and neurotoxic adverse effects. Dexmedetomidine is a highly selective an alpha 2 agonist which, when used as an adjuvant , prolongs the duration of action without causing respiratory depression. Nalbuphine is recently introduced opioid agonist-antagonist. Unlike other opioids it has got ceiling effect. Furthermore,use of ultrasound (US) has significantly improved the quality of nerve blocks by direct visualization of nerves and related anatomical structures, needle trajectory and spread of local anesthetics (LAs) during injection [2-7]. In addition, US guidance increases success rate, minimizes LAs volume needed for effective nerve block, and avoids potential complications such as intraneural or intravascular injection [2,4,5]. In this study, we plan to compare the efficacy of dexmedetomidine and nalbuphine as an adjuvant to levobupivacaine in ultrasound guided supraclavicular brachial plexus block. |