| CTRI Number |
CTRI/2013/12/004209 [Registered on: 12/12/2013] Trial Registered Retrospectively |
| Last Modified On: |
27/03/2014 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effect of addition of dexmedetomidine with local anesthesia on pain relief after arm and hand surgery |
|
Scientific Title of Study
|
Effect of adding dexmedetomidine with ropivacaine on the characterstics of supraclavicular brachial plexus block in patients undergoing upper limb surgeries |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neerja Bharti |
| Designation |
Additional professor |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Anesthesia PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9915575145 |
| Fax |
|
| Email |
bhartineerja@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dinesh K Sardana |
| Designation |
Senior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Anesthesia
PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
dineshsardana24@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dinesh K Sardana |
| Designation |
Senior Resident |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Department of Anesthesia
PGIMER, Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
dineshsardana24@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesia and Intensive care, PGIMER |
|
|
Primary Sponsor
|
| Name |
Director |
| Address |
Post Graduate Institute of Medical Education and Research (PGIMER),
Chandigarh, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Neerja Bharti |
Operation Theater Nehru Hospital |
Post Graduate Institute of Medical Education and Research
Chandigarh
CHANDIGARH |
9915575145
bhartineerja@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Review Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
scheduled for forearm and hand surgeries , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Dexmedetomidine |
1 µg /kg of dexmedetomidine with local anesthetics in supraclavicular brachial plexus block |
| Comparator Agent |
placebo (Normal Saline) |
Normal saline 1 ml with local anesthetics was given in supraclavicular brachial plexus block |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
60 patients of either sex aged between 20-60 years, ASA physical status I-II, scheduled for forearm and hand surgeries were included |
|
| ExclusionCriteria |
| Details |
Patients receiving adrenoreceptor agonist or antagonist, neurological deficit in the upper limb, history of cardiac disease, respiratory disease, renal and hepatic failure, pregnant women and allergy to local anesthetics were excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Postoperative pain and Duration of analgesia(time interval from administration of block to 1st rescue analgesia required) |
Postoperative pain was assessed every 30 min for 2 hr, every 1 hr for 6 hr, every 2 hr till 12 hr,
and then at 24 hr postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| onset and duration of sensory and motor blockade |
assessed every 5 min till 30 min and then every 30 min till resolution of block |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
08/11/2011 |
| 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="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This prospective randomized double blind study was conducted to assess the effects of dexmedetomidine as an adjunct to local anesthetics in supraclavicular brachial plexus block on postoperative analgesia and block characteristics.
Sixty adult patients of ASA grade 1 and 2 undergoing upper limb surgery were randomly allocated into two groups. Control group received equal volume of 0.75% ropivacaine and 2% lidocaine with adrenaline (1 in 2,00000) while dexmedetomidine group received I mcg/kg dexmedetomidine along with similar local anesthetics (total volume being 0.5 ml/kg in both groups) in supraclavicular brachial plexus block.Patients were observed for hemodynamic stability, onset and duration of block, postoperative pain, duration of analgesia, sedation and any adverse effects.
We observed that addition of dexmedetomidine to local anesthetics in supraclavicular brachial plexus block significantly increases the duration of postoperative analgesia and reduces the requirement of rescue analgesia. The onset of block was faster and the duration was prolonged in dexmedetomidine group as compared to control group. Patients in dexmedetomidine group were sedated but easily arousable. No adverse effects like hypotension, bradycardia, hypoxia or respiratory depression were reported.
|