| CTRI Number |
CTRI/2025/04/085876 [Registered on: 29/04/2025] Trial Registered Prospectively |
| Last Modified On: |
28/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Two Anaesthesia Techniques for Pain Relief in upper limb fractures. |
|
Scientific Title of Study
|
Comparative Evaluation of Axillary Approach v/s Retroclavicular (RAPTIR) Approach in Ultrasound Guided Brachial Plexus Block for Distal Upper Limb Surgery: A Prospective Randomized Comparative Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Suruchi |
| Designation |
Associate Professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institue of medical sciences |
| Address |
Department of Anaesthesiology, First floor, A block,Sanjay Gandhi Post Graduate Institue of medical sciences, Raibareilly road, Lucknow
Lucknow UTTAR PRADESH 226014 India |
| Phone |
9786025292 |
| Fax |
|
| Email |
suruchi0904@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anjali Chaudhary |
| Designation |
PG Resident |
| Affiliation |
Sanjay Gandhi Post Graduate Institue of medical sciences |
| Address |
Department of Anaesthesiology, First floor, A block,Sanjay Gandhi Post Graduate Institue of medical sciences, Raibareilly road, Lucknow
Lucknow UTTAR PRADESH 226014 India |
| Phone |
8447234721 |
| Fax |
|
| Email |
anjalichaudhary1210@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Suruchi |
| Designation |
Associate Professor |
| Affiliation |
Sanjay Gandhi Post Graduate Institue of medical sciences |
| Address |
Department of Anaesthesiology, First floor, A block,Sanjay Gandhi Post Graduate Institue of medical sciences, Raibareilly road, Lucknow
Lucknow UTTAR PRADESH 226014 India |
| Phone |
9786025292 |
| Fax |
|
| Email |
suruchi0904@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjay Gandhi Post Graduate Institue of medical sciences,Raibareilly road, lucknow, Uttar Pradesh, 226014 |
|
|
Primary Sponsor
|
| Name |
Sanjay Gandhi Post Graduate Institue of medical sciences, |
| Address |
Raibareilly road, lucknow, Uttar Pradesh, 226014 |
| 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 |
| Dr Suruchi |
Sanjay Gandhi Post Graduate Institue of medical sciences |
Department of Anaesthesiology, First floor, A block Lucknow UTTAR PRADESH |
9786025292
suruchi0904@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Axillary approach to Brachial plexus block |
Drug used: 25 ml of 0.5% bupivacaine
Total duration of placement of block will be noted. |
| Intervention |
RAPTIR- Retroclavicular approach to the infraclavicular Block |
Drug used: 25 ml of 0.5% bupivacaine
Total duration of placement of block will be noted. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Elective or urgent surgery of the hand wrist forearm
American Society of Anaesthesiologists ASA class I to III
|
|
| ExclusionCriteria |
| Details |
Patient refusal
Previous surgery or gross anatomical deformity/Fracture of the clavicle
BMI greater than 30
Systemic or local infection at the needle entry point
Coagulopathy
Severe pulmonary condition
Local anaesthetic allergy
Pre-existing neurologic symptoms in the ipsilateral limb
Pregnancy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary outcome is the performance time expressed in minutes. |
Measured at 15 minutes from the start of the procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Sensory block assessment
Motor block assessment
Onset of block motor block (14 out of 16)
Success of block
Pain during the procedure
Pain in first 24 hours
Time to first analgesic request
Early and late complications
|
1.Sensory block assessed at 5 10 20 and 30 mins.
2.Motor block assesses at 5 10 20 and 30 mins.
3.Pain in first 24 hours
4.Time to first analgesic request
|
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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
|
N/A |
|
Date of First Enrollment (India)
|
02/06/2025 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
· Regional anesthesia
for upper limb surgery provides many advantages over general anesthesia,
especially in orthopedic surgery.The
Brachial plexus block (BPB) is less invasive and as equally effective as
general anaesthesia to anaesthetize the upper limbs. The most important of
them is the control of postoperative pain, which results in decreased
postoperative opioid requirements and the patient’s recovery time. With the introduction of the ultrasound-guided
technique, the success rate has reached 95-100%. Therefore, a different
indicator is required in comparative studies today, and the procedure time is
considered as an important indicator after the success rate. There have been no comparative studies between
the widely practiced Axillary brachial plexus block and the recently introduced
and relatively less practiced
Retroclavicular approach to Infraclavicular brachial plexus block
(RAPTIR).Thus we aim to conduct this study to compare various parameters of
both these approaches with the main emphasis on the time to perform these
blocks.The primary objective is to determine the procedure time which is
summation of imaging time and needling time. The secondary objectives include
analysis of onset time, block success rate, procedure related
pain, NRS (static/dynamic) Score in postoperative period up to 24 hrs, Time to
first rescue analgesia, Complications. Following approval
from the
Institutional Ethics Committee and registering the trial in CTRI and after
obtaining written and informed consent from the patients, a randomised
comparative study will be conducted over a period of 18 months in patients
undergoing distal upper limb surgeries. Patients will be randomly allocated by
use of block randomization method using software_” sealed envelope”. The study
population will be above years, ASA I,II and III, undergoing distal upper limb
surgery. Exclusion criteria includes patient refusal,
previous surgery or
gross anatomical deformity/Fracture of the clavicle, BMI >30 kg/m2,
Systemic or local
infection at the needle entry point,
Coagulopathy, Severe pulmonary condition,
Local anaesthetic
allergy, Pre-existing neurologic symptoms in the ipsilateral limb, Pregnancy. As per randomization, patients will be given
either axillary block or RAPTIR block with 25 ml of 0.5% Bupivacaine. The
primary outcome is the performance time, expressed in minutes. The performance
time corresponds to the sum of imaging time and needling time, which both are
secondary outcomes. Secondary outcome measures: Onset of block – Measured as
Composite score of sensory and motor block (14 out of 16), Success of plexus
block, Pain assessment will be done using a 10-cm Numeric Rating Scale
immediately after the block and in first 24 hours, Time to first analgesic
request, Early and late complications: the incidence of needle-induced
paresthesia, vascular puncture, Horner syndrome, dyspnea, and symptoms of LA
toxicity will be noted. All patients will be followed at 48 hours after surgery
to ask for any delayed complications, such as dyspnea, paresthesia, weaknesses,
pain at the puncture site or haematoma. |