| CTRI Number |
CTRI/2018/04/013158 [Registered on: 11/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
31/03/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of dexmedetomidine and dexamethasone as adjuvants to levobupivacaine in axillary brachial plexus block |
|
Scientific Title of Study
|
A comparative study of dexmedetomidine and dexamethasone as adjuvants to levobupivacaine in ultrasound guided axillary brachial plexus block. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Tania Singh |
| Designation |
Resident doctor |
| Affiliation |
Dayanand Medical College and Hospital, Ludhiana |
| Address |
Department of Anesthesia, Dayanand Medical College and Hospital, Tagore Nagar, Civil Lines, Ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
8968677948 |
| Fax |
|
| Email |
tsjasial@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dinesh Sood |
| Designation |
Professor, Department of Anesthesia, DMCH, Ludhiana |
| Affiliation |
Dayanand Medical College and Hospital, Ludhiana |
| Address |
Department of Anesthesia,
Dayanand Medical College and Hospital, Tagore Nagar, Civil Lines, Ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
9814020817 |
| Fax |
|
| Email |
drdineshsood@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Tania Singh |
| Designation |
Resident doctor |
| Affiliation |
Dayanand Medical College and Hospital, Ludhiana |
| Address |
Department of Anesthesia, Dayanand Medical College and Hospital, Tagore Nagar, Civil Lines, Ludhiana
Ludhiana
PUNJAB
141001
India |
| Phone |
8968677948 |
| Fax |
|
| Email |
tsjasial@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Medical College and Hospital, Ludhiana |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesia Dayanand Medical College and Hospital |
| Address |
Dayanand Medical College and Hospital, Tagore Nagar, Civil Lines, Ludhiana, Punjab |
| Type of Sponsor |
Private 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 |
| Tania Singh |
Dayanand Medical College and Hospital, Ludhiana |
Neuro-ortho OT complex and surgery OT complex, first floor
Department of Anesthesia
Ludhiana
PUNJAB |
8968677948
tsjasial@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Committee, Dayanand Medical College and Hospital, Ludhiana |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Scheduled for forearm or hand surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Dexamethasone |
as adjuvant to levobupivacaine in ultrasound guided axillary brachial plexus block |
| Intervention |
Dexmedetomidine |
as adjuvant to levobupivacaine in ultrasound guided axillary brachial plexus block |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologists (ASA) physical status I and II
Scheduled for surgery on forearm or hand |
|
| ExclusionCriteria |
| Details |
Uncooperative patients, psychiatric problems, inability to understand the information provided or inability to give the consent.
Any neurological deficit, peripheral neuropathies, myopathies or chronic pain in the operative limb.
History of anaphylaxis to local anaesthetics or known allergy to any of the study drugs to be used.
Any history of bleeding diathesis or coagulation abnormalities.
Any skin infection or local disease at the needle insertion site. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time to onset of sensory and motor block.
Duration of sensory and motor block.
Duration of analgesia and total analgesic consumption in 24 hours. |
Onset of sensory and motor block as the time from end of local anesthetic administration to achievement of complete sensory and motor block respectively.
Duration of sensory block as time from onset of sensory block to return of cold sensation.
Duration of motor block as time from onset of motor block to return of motor power.
Duration of analgesia as time from onset of complete sensory block to first intake of rescue analgesia. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Pain scores
Adverse effects- Hypotension, Bradycardia, Tachycardia, Hypoxemia, Sedation, Nausea, Vomiting, Pruritis, Skin Rash, Dry mouth, Dyspnea |
Pain assessed by Visual Analogue scale
Hypotension(noninvasive blood pressure less than 20% of baseline)
Bradycardia(heart rate less than 60beats/minute)
Tachycardia(heart rate more than 100beats/minute)
Hypoxemia(oxygen saturation less than 90%)
Sedation assessed by Modified Ramsay sedation scale
Nausea and vomiting assessed by Nausea and vomiting scale. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/03/2015 |
| Date of Study Completion (India) |
21/05/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
1) Abdallah FW, Brull R. Facilitatory effects of perineural dexmedetomidine on neuraxial and peripheral nerve block: a systematic review and meta-analysis. Br J Anaesth.2013;110(6):915-25.
2) Choi S, Rodseth R, McCartney CJL. Effects of dexamethasone as a local anaesthetic adjuvant for brachial plexus block: a systematic review and meta-analysis of randomized trials. Br J Anaesth.2014;112(3):427-39. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A prospective randomized double blind study was conducted on 40 patients scheduled for surgery on forearm or hand. The aim of the study was to compare the efficacy of Dexmedetomidine (100 mcg) and Dexamethasone ( 8 mg) when used as adjuvants to 40 ml of 0.5% levobupivacaine in ultrasound guided axillary brachial plexus block in terms of the time to onset of sensory and motor block, duration of sensory and motor block, duration of analgesia, total analgesic consumption in 24 hours and any adverse effects. We found that the mean time to onset of sensory and motor block was significantly shorter and mean duration of sensory and motor block as well as duration of analgesia was significantly longer in dexmedetomidine group as compared to dexamethasone group. We concluded that dexmedetomidine (100 mcg) is a better choice over dexamethasone (8 mg) for perineural use as an adjuvant to 0.5% levobupivacaine in ultrasound guided axillary brachial plexus block. |