| CTRI Number |
CTRI/2017/03/008199 [Registered on: 23/03/2017] Trial Registered Retrospectively |
| Last Modified On: |
10/03/2017 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
supraclavicular brachial plexus block with Levobupivacaine and Dexmeditomidine |
|
Scientific Title of Study
|
Effect of Dexmedetomidine on characteristics of ultrasound guided supraclavicular brachial plexus block with Levobupivacaine- a prospective double blind randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhumireddy Suneel reddy |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College , Manipal |
| Address |
Department of Anaesthesiology, Kasturba Medical College,Manipal University, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
|
| Fax |
|
| Email |
suneelreddy547@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Yogesh K Gaude |
| Designation |
Assistant professor |
| Affiliation |
Kasturba Medical College , Manipal |
| Address |
Department of Anaesthesiology, Kasturba Medical College,Manipal University, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
|
| Fax |
|
| Email |
yogeshgaude@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr KGurudas Kini |
| Designation |
Professor |
| Affiliation |
Kasturba Medical College , Manipal |
| Address |
Department of Anaesthesiology, Kasturba Medical College,Manipal University, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
|
| Fax |
|
| Email |
kini.gurudas@gmail.com |
|
|
Source of Monetary or Material Support
|
| PG Thesis fund, Manipal University,Madhavnagar, Manipal, Karnataka , India |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 Bhumireddy Suneel reddy |
Kasturba Hospital, Manipal |
Department of Anaesthesiology, OT Complex Kasturba Medical College,Manipal University, Manipal Udupi KARNATAKA |
07760003883
suneelreddy547@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Hospital, Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
American society of anesthesiologists (ASA) physical status: I-II, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Levobupivacaine in ultrasound guided supraclavicular brachial plexus block |
Group L- Patients receiving (30ml 0.5% Levobupivacaine +1ml normal saline) perineural + 20 ml 0.9% Normal saline IV infusion over 20 minute to be started soon after performance of nerve block.
|
| Comparator Agent |
Levobupivacaine with intravenous Dexmedetomidine in ultrasound guided supraclavicular brachial plexus block |
Group LDi- Patients receiving (30ml of 0.5% Levobupivacaine + 1ml normal saline) perineural + dexmedetomidine 1ug/kg in 20ml 0.9% Normal saline IV infusion over 20 minute to be started soon after performance of nerve block. |
| Comparator Agent |
Levobupivacaine with perineural Dexmedetomidine in ultrasound guided supraclavicular brachial plexus block |
Group LDp- Patients receiving (30ml of 0.5% Levobupivacaine + 1mcg/kg of Dexmedetomidine in 1ml normal saline) perineural+ 20ml 0.9% Normal saline IV infusion over 20 minute to be started soon after performance of nerve block. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: 18 – 60 years
2. American society of anesthesiologists (ASA) physical status: I-II
3. Elbow, forearm and hand surgeries
|
|
| ExclusionCriteria |
| Details |
1. Patient refusal for procedure
2. Any bleeding disorder or patients on anticoagulants
3. Neurological deficits involving brachial plexus
4. Body weight less than 50 Kg
5. Patients with known allergy to local anaesthetics
6. Local infection at injection site
7. History of seizures
8. History of pneumothorax
9. Pregnant women
10. ASA grade III-IV
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.The onset of sensory and motor block
2.Duration of sensory/ motor blockade
|
Time interval between administration of study drug to loss of pin prick sensation in all 4 nerve territories. Time interval between of administration of study drug to a motor score of 2 or lower according to modified Bromage scale in all 4 nerve territories.Time interval between loss of pin prick sensation to reappearance of sensation in all 4 nerve territories.
Time interval between attainment of ≤Grade 2 motor block to complete recovery of motor power in all 4 nerve territories.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Sedation score
Complications / side effects if any
|
sedation score will be assessed after completion of block and every 5 min till end of surgical procedure.
Immediate complications will be noted and side effects will be noted post operatively |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/09/2014 |
| Date of Study Completion (India) |
Date Missing |
| 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
|
NA |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Brachial
plexus block at various levels has been in use for upper extremity surgeries
since its description by Kulenkampff in 1928(1). Supraclavicular
approach to brachial plexus block has remained the most popular because of its
ubiquitous application for upper extremity surgeries, predictability and
complete anesthesia of upper limb(2). After a brief
period of disfavor due to risk of pneumothorax, application of nerve
stimulation and recent introduction of ultrasonography for localization of
brachial plexus has rekindled anesthesiologist’s interest in supraclavicular
block(3).
Although
bupivacaine remains commonly used local anesthetic for performance of nerve
blocks due to its long duration of action and good motor blockade, concerns
about toxicity at higher doses remain. Levobupivacaine, a less cardiotoxic s- isomer
of bupivacaine is proved to be similar to bupivacaine if not for
pharmaco-economic considerations hence proposed as a safer alternative to the
former for performance of nerve blocks(4).
Even
with increasing use of perineural catheters for pain relief, many
anesthesiologists still continue to use single-shot techniques for nerve blocks.
This has led to the practice of using additives to local anesthetics with intent
to improve the quality and duration of block. Among others, selective α2
agonist dexmedetomidine has been studied for its ability to affect the axillary
brachial plexus block characteristics. Intravenous administration of dexmedetomidine
along with spinal anesthesia has been found to prolong the duration of block(5–7). Few studies
have evaluated the effect of intravenous dexmedetomidine on brachial plexus
block(8). Albeit the
availability of studies on the effect of dexmedetomidine on axillary brachial
plexus block performed by nerve stimulator guidance with Levobupivacaine (9), no study has
evaluated the effect of dexmedetomidine on ultrasound guided supraclavicular
brachial plexus block with Levobupivacaine. |