| CTRI Number |
CTRI/2014/08/004822 [Registered on: 05/08/2014] Trial Registered Retrospectively |
| Last Modified On: |
04/08/2014 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of 3 techniques of regional anaesthesia for upper arm and forearm surgery |
|
Scientific Title of Study
|
Comparison of Ultrasound-Guided Supraclavicular, Infraclavicular and Interscalene Brachial Plexus Blocks for Upper Limb Surgery: A Randomised, Observer-Blinded Study. |
| 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 |
PGIMER |
| Address |
Department of Anaesthesia and Intensive Care
Chandigarh
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
bhartineerja@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Neerja Bharti |
| Designation |
Additional professor |
| Affiliation |
PGIMER |
| Address |
Department of Anaesthesia and Intensive Care
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
bhartineerja@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Neerja Bharti |
| Designation |
Additional professor |
| Affiliation |
PGIMER |
| Address |
Department of Anaesthesia and Intensive Care
CHANDIGARH
160012
India |
| Phone |
|
| Fax |
|
| Email |
bhartineerja@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia,Post Graduate Institute of Medical Education and Research, Chandigarh, INDIA |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of Medical Education and Research |
| Address |
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, PGIMER
Chandigarh
CHANDIGARH |
9914209527
bhartineerja@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Review Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
posted for elective surgery of arm or forearm, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound guided infraclavicular block |
the ultrasound probe was applied in para sagittal plane below the clavicle to obtain a short-axis view of the axillary artery. The puncture site was located at the junction of the clavicle and the coracoid process. The needle was advanced in- plane until the tip was located just posterior to the axillary artery. After confirmation of the appropriate needle position by neurostimulation, the same amount of local anaesthetic was injected circumferentially around the artery |
| Comparator Agent |
Ultrasound guided Interscalene block |
The transducer held in a coronal-oblique position, the brachial plexus was imaged at the supraclavicular level and then followed cephalad until C5, C6 and C7 nerve roots were evident in the space between anterior and middle scalene muscles. At this level, stimuplex needle was inserted in-plane and advanced toward the visible nerve fascicles of C6-C7 nerve roots. After nerve-stimulator confirmation, local anaesthetic was injected caudate to the C6 nerve root under ultrasound visualization |
| Intervention |
Ultrasound guided supraclavicular block |
The ultrasound probe was placed in coronal planein the supraclavicular fossa to obtain a short-axis view of the subclavian artery.The stimuplex needle was advanced in-plane from lateral-to-medial direction until the tip was located near the subclavian artery. Appropriate needle position was confirmed by neurostimulation and the local anaesthetic (0.5 mL/kg) was injected in incremental doses around the artery to obtain a circumferential spread. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Sixty patients of ASA physical status of I-III, undergoing upper arm and forearm surgery |
|
| ExclusionCriteria |
| Details |
Patients with clinically significant coagulopathy, morbid obesity (body mass index>40), infection at the injection site, allergy to local anaesthetics, mental incapacity or language barrier precluding assessment were excluded |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| the block onset time |
The sensory and motor blockade were assessed every 5 min intervals till complete or maximum sensory and motor blockade was achieved
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| the duration of analgesia and safety |
Postoperative period |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
19/07/2012 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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 trial was conducted to compare the ease of performance and effectiveness of ultrasound guided supraclavicular, infraclavicular and interscalene techniques of bracheal plexus block for upper arm and forearm surgery. Sixty adult patients of ASA grade I-III undergoing upper limb surgery were randomly allocated into 3 groups to receive ultrasound-guided supraclavicular, infraclavicular and interscalene blocks.The imaging times and block performance times were comparable among groups.
Though, the onset time was longer in interscalene group as compared to other groups, no difference was observed in the success rate, duration of analgesia and adverse effects. We concluded that ultrasound guided interscalene block can be performed as rapidly as supraclavicular and infraclavicular blocks and results in
similar success rate for upper limb surgery.
|