CTRI Number |
CTRI/2019/07/020470 [Registered on: 31/07/2019] Trial Registered Prospectively |
Last Modified On: |
30/07/2019 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
A comparative study of anaesthetic injection into the nerves above and below collar bone for hand surgeries using ultrasound |
Scientific Title of Study
|
A comparison between ultrasound guided supraclavicular and infraclavicular approach to brachial plexus block for upper limb surgery: a randomized 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 |
Anis Fathima |
Designation |
Junior Resident |
Affiliation |
PONDICHERRY INSTITUTE OF MEDICAL SCIENCE |
Address |
Room no 101,Annex PG hostel
Pondicherry Institute Of Medical Sciences
Kalapet
Puducherry
Pondicherry PONDICHERRY 605014 India |
Phone |
9786635828 |
Fax |
|
Email |
mailanisfathima@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Nagalakshmi |
Designation |
Associate Professor |
Affiliation |
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES |
Address |
Associate Professor
Department Of Anaesthesiology
Pondicherry Institute Of medical sciences,
Kalapet,
Puducherry
Pondicherry PONDICHERRY 605014 India |
Phone |
9894510137 |
Fax |
|
Email |
vedha83@gmail.com |
|
Details of Contact Person Public Query
|
Name |
Dr Nagalakshmi |
Designation |
Associate Professor |
Affiliation |
PONDICHERRY INSTITUTE OF MEDICAL SCIENCES |
Address |
Associate Professor
Department Of Anaesthesiology
Pondicherry Institute Of medical sciences,
Kalapet,
Puducherry
Pondicherry PONDICHERRY 605014 India |
Phone |
9894510137 |
Fax |
|
Email |
vedha83@gmail.com |
|
Source of Monetary or Material Support
|
Pondicherry Institute Of medical sciences,
Kalapet,Ganapathichettikulam
Puducherry.
Pin:605014
|
|
Primary Sponsor
|
Name |
Dr Anis Fathima |
Address |
Junior Resident,
Department Of Anaesthesiology,
PIMS,
Puducherry
Pin 605014
India |
Type of Sponsor |
Other [Dr Anis Fathima] |
|
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 Anis Fathima |
Pondicherry Institute of Medical Sciences |
Pondicherry
Institute of Medical
Sciences is a
multispeciality hospital
and well reputed
teaching institute at
kalapet in the Union
territory of Puducherry
Departmentof Anaesthesiology
Kalathumettupathai,
Ganapathichettikulam,
Kalapet,
Puducherry, 605014
India Pondicherry PONDICHERRY |
9786635828
mailanisfathima@gmail.com |
|
Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
PIMS INSTITUTE ETHICS COMMITTEE(IEC), Registered with CDSCO- Reg No ECR/400/Inst/Py/2013, Pondicherry Institute Of Medical Sciences, Kalapet, Puducherry - 605014 |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
(1) ICD-10 Condition: S578||Crushing injury of forearm, (2) ICD-10 Condition: S629||Unspecified fracture of wrist andhand, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
infraclavicular block |
patients who receive infraclavicular block for upper limb surgery |
Comparator Agent |
supraclavicular block |
patients who receive supraclavicular block for upper limb surgery |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1.Patients according to American Society of Anaesthesiologists grade 1 or 2.
2.Age between 18-60 years
3.Surgeries involving upper limb (hand and forearm) lasting more than 1 & 1/2 hours
|
|
ExclusionCriteria |
Details |
4. BMI morethan 30 kg/m2
5. Pregnant women
6. Bleeding disorders, anticoagulant therapy or deranged coagulation profile
7. Pre-excisting motor or sensory deficit in the operative limb
8. Infection in the area of injection
9.Hypersensitivity to local anaesthetic agents
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To compare the onset of sensory and motor blockade of brachial plexus between
Group A- block by infraclavicular approach
Group B- block by supraclavicular approach
|
24 - 48 hrs
|
|
Secondary Outcome
|
Outcome |
TimePoints |
1.To compare the duration of sensory and motor block between two Groups.
2.To compare the occurrence of ulnar nerve sparing between the two groups.
3.To detect and document any intraoperative /postoperative complications if present.
|
24 - 48 hrs |
|
Target Sample Size
|
Total Sample Size="64" Sample Size from India="64"
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 2/ Phase 3 |
Date of First Enrollment (India)
|
07/08/2019 |
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="1" Months="6" Days="0" |
Recruitment Status of Trial (Global)
|
Not Applicable |
Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
|
study will be published once it gets over |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Upperlimb surgeries can
be performed under general or regional anaesthesia. Regional anaesthesia
offers several advantages over general anaesthesia such as a
conscious patient , avoidance of polypharmacy and airway Intervention, better
hemodynamics, good post- operative analgesia, early resumption of activities,
reduced hospital stay and improved functional outcome. Brachial plexus block at
the level of the clavicle can anaesthetize all four distal upper extremity
nerve territories producing an intense blockage. Supraclavicular brachial
plexus block is a popular technique for upper limb surgeries because of its quick
onset and high success rate. This is because at this level, the
brachial plexus elements are tightly grouped and produces a good neurological
block. Corner pocket sparing and thereby a less dense ulnar blockade is a
problem in supraclavicular block. So supraclavicular blockade requires a
two point injection. There is a possibility of horner’s syndrome,
phrenic nerve palsy and pneumothorax which may also be considered as its
disadvantage. The main advantage of infraclavicular block is
the fewer incidences of complications with reduced the risks of inadvertent
lung/pleural puncture and avoidance of injury to the neurovascular structures
in the neck. It is an ideal site for catheter technique for continuous infusion
of local anaesthetics. There is lesser incidence of ulnar nerve sparing with
single point injection. The disadvantage is that plexus is situated deeper at
this level and the angle of approach is more acute. This makes the
visualization of the relevant anatomy and the needle tip, challenging in
inexperienced hands and in obese patients. Although both supraclavicular
and infraclavicular blocks can be performed for upper limb surgeries,
anaesthesiologists often have an inclination to supraclavicular block over
infraclavicular block because of an ease of administration. The advent of
real time ultrasound helps in direct visualisation of nerves and their
surrounding anatomy. It also allows for continuous
observation of the needle tip and the spread of local anaesthetics, reduced
local anaesthetic dose required to achieve a good block, avoidance of injury to
the nearby vascular structures making ultrasound guided brachial plexus block
highly appealing to anaesthesiologists. The rational of this study is to
evaluate the efficacy of ultrasound guided infraclavicular approach of brachial
plexus block compared to ultrasound guided supraclavicular approach of brachial
plexus block in upper limb surgeries.
|