| CTRI Number |
CTRI/2023/06/053528 [Registered on: 05/06/2023] Trial Registered Prospectively |
| Last Modified On: |
04/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
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Type of Study
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Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
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Public Title of Study
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Comparision of two approaches of infraclavicular brachial plexus block for below elbow fractures under USG and PNS guidance |
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Scientific Title of Study
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Comparative evaluation of two approaches of infraclavicular brachial plexus block for below elbow orthopaedic surgeries under dual guidance of USG and PNS- A randomised single blinded clinical study |
| Trial Acronym |
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Secondary IDs if Any
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| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Zalak Patel |
| Designation |
Resident Doctor |
| Affiliation |
GMERS medical college and hospital, Gotri, Vadodara |
| Address |
Department of anaesthesiology, GMERS medical college and hospital, Gotri, Vadodara
Vadodara GUJARAT 390021 India |
| Phone |
7567296079 |
| Fax |
|
| Email |
drzpatel03@gmail.com |
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Details of Contact Person Scientific Query
|
| Name |
Dr Bhavesh Dalwadi |
| Designation |
Associate Professor, Department of anaesthesiology, GMERS Gotri, Vadodara |
| Affiliation |
GMERS medical college and hospital, Gotri, Vadodara |
| Address |
Old TB Campus,Department of anaesthesiology, GMERS medical college and hospital, Gotri, Vadodara
Vadodara GUJARAT 390021 India |
| Phone |
6354210984 |
| Fax |
|
| Email |
bhaveshkdalwadi@gmail.com |
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Details of Contact Person Public Query
|
| Name |
Dr Bhavesh Dalwadi |
| Designation |
Associate Professor, Department of anaesthesiology, GMERS Gotri, Vadodara |
| Affiliation |
GMERS medical college and hospital, Gotri, Vadodara |
| Address |
Old TB Campus,Department of anaesthesiology, GMERS medical college and hospital, Gotri, Vadodara
Vadodara GUJARAT 390021 India |
| Phone |
6354210984 |
| Fax |
|
| Email |
bhaveshkdalwadi@gmail.com |
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Source of Monetary or Material Support
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| GMERS Medical college and hospital, Gotri, Vadodara |
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Primary Sponsor
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| Name |
GMERS Medical college and Hospital |
| Address |
Old TB Campus, Gotri main Road, Gotri, Vadodara |
| Type of Sponsor |
Government medical college |
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Details of Secondary Sponsor
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Countries of Recruitment
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India |
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Sites of Study
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| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Zalak Patel |
GMERS Medical college and hospital |
Orthopaedic operation theatre,Old TB campus,GMERS medical college and hospital, Gotri main Road, Gotri, Vadodara Vadodara GUJARAT |
7567296079
drzpatel03@gmail.com |
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Details of Ethics Committee
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| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IHEC GMERS MEdical college and hospital, Gotri, Vadodara |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
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| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S00-T88||Injury, poisoning and certain other consequences of external causes, (2) ICD-10 Condition: S50-S59||Injuries to the elbow and forearm, (3) ICD-10 Condition: S60-S69||Injuries to the wrist, hand and fingers, (4) ICD-10 Condition: S52||Fracture of forearm, (5) ICD-10 Condition: S62||Fracture at wrist and hand level, (6) ICD-10 Condition: S529||Unspecified fracture of forearm, (7) ICD-10 Condition: S629||Unspecified fracture of wrist andhand, |
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Intervention / Comparator Agent
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| Type |
Name |
Details |
| Intervention |
Classical infraclavicular block |
USG and PNS guided CIB under all aseptic precautions with injection Levobupivcaine 0.5% 15ml and injection lignocaine 2% 15ml
-Procedure time - From the contact of the ultrasound probe with the patient to the removal of needle |
| Comparator Agent |
Retroclavicular block |
USG and PNS guided RCB under all aseptic precautions with injection Levobupivcaine 0.5% 15ml and injection lignocaine 2% 15ml
Procedure time - From the contact of the ultrasound probe with the patient to the removal of needle |
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Inclusion Criteria
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| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Age: 18-60 years
2)BMI: <30 kg/m2
3) American society of anaesthesia grading: I and II
4) Forearm, hand and wrist fractures |
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| ExclusionCriteria |
| Details |
1) Patient refusal
2) Allergy to LA
3) Local site infection
4) Anatomical distortion of clavicle
5) Polytrauma
6) Pre-existing neurological deficit
7) Pre-existing systemic illness like uncontrolled hypertension, ischemic heart disease, severe pulmonary disease, renal or hepatic dysfunction,sepsis
8) Surgeries requiring tourniquet
9) Coagulopathy
10) Patients with hearing disability, dementia, psychiatric illness or mentally challenged, having language barrier, who cannot express scoring system used in the study
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
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Participant Blinded |
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Primary Outcome
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| Outcome |
TimePoints |
| To compare the procedure time between both the groups |
-Procedure time (at baseline) - From the contact of the ultrasound probe with the patient to the removal of needle
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Secondary Outcome
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| Outcome |
TimePoints |
| Needle visibility |
Whole needle with tip-3 Needle course partially seen-2 Only needle impression-1
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| Needle passes |
During the procedure, number of times the needle required redirection or retraction of at least 10 mm for ≥2 times will be recorded as an “additional passâ€. |
| To compare success rates |
Block success: When a minimal composite sensorimotor score of 14 is achieved, the surgeon can proceed with surgery.
Block failure: Patients requiring supplemental analgesia, additional LA, general anaesthesia or having composite sensorimotor score 14 will be considered as a failure of study. |
| To compare onset of sensory & motor block in both groups |
After LA injection, sensory & motor blockade will be evaluated by an observer every 5 min, until 30 min. |
| Complications |
Complications if occur any will be observed intra-operative period |
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Target Sample Size
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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" |
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Phase of Trial
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N/A |
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Date of First Enrollment (India)
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14/06/2023 |
| 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 |
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Estimated Duration of Trial
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Years="1" Months="0" Days="0" |
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Recruitment Status of Trial (Global)
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Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
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Publication Details
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NIL |
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Individual Participant Data (IPD) Sharing Statement
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Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
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Brief Summary
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AIM To compare retroclavicular and classical approaches to infraclavicular brachial plexus block for providing anaesthesia for forearm surgeries under dual guidance of ultrasound and peripheral nerve stimulator. OBJECTIVES Primary objective: To compare the procedure time between both the groups Secondary objectives: Needle visibility Number of needle passes Success rate Onset and duration of sensory and motor block Complications if any METHODLOGY Ethical consideration- The principles of Helsinki declaration will be followed throughout the study. This study will be conducted after getting approval from local Ethical Committee of GMERS Medical College and Hospital, Gotri, Vadodara. It will be registered under clinical trial registry of India. Written and informed consent will be taken from all participants. Data collected will be kept confidential. Study design- Randomised controlled, single blinded study Study setting- Tertiary care teaching hospital (GMERS medical college and hospital, Gotri, Vadodara) Study duration- approximately 1 year Study population- Total 80 patients with below elbow trauma undergoing orthopaedic surgeries of forearm, wrist and hand under regional anaesthesia.
Inclusion criteria: Age: 18-60 years BMI : < 25 kg/m2 American society of Anaesthesia grading : I and II Exclusion criteria: Patient refusal Allergy to LA Local site infection Anatomical distortion of clavicle Polytrauma Pre-existing neurological deficit Pre-existing systemic illness like uncontrolled hypertension or ischemic heart disease, severe pulmonary disease, renal or hepatic dysfunction, sepsis Surgeries requiring tourniquet Coagulopathy Patients with hearing disability, dementia, psychiatric illness or mentally challenged or having a language barrier, who cannot express scoring system used in the study
STUDY PROCEDURE Randomization and allocation : Patients will be randomly assigned to either CIB (C) or RCB (R) group in 1:1 ratio using predetermined computer generated randomisation table. To ensure concealment, sequentially numbered, opaque and sealed envelopes will be used. Only the research assistant will have access to the envelopes. A research assistant, resident or Anaesthesiology department staff member will be responsible for assessing participant eligibility and recruitment. InterventionPatients will be randomized in two groups:
Group C (n=40): Classical approach of ICB Group R (n=40): Retroclavicular approach of ICB After a detailed Pre-Anaesthetic examination and taking patient in a pre-operative room, an 18 or 20 gauge intravenous catheter will be secured in upper limb contralateral to surgical upper limb and intravenous pre-medication (0.03 mg/kg midazolam) will be administered to all patients. Supplemental oxygen (by nasal cannula at 4L/min) and standard ASA monitors will be applied throughout the procedure. All blocks will be performed under aseptic and antiseptic precautions and after local anaesthesia infiltration of skin (2 or 3 ml of inj. Lignocaine 1%). Inj. Levobupivacaine 0.5%- 15 ml (2 mg/kg) and inj. Lignocaine 0.2%- 15ml (5 mg/kg) will be given to all patients.
USG+ PNS guided Classical approach With the patient in the proper position with arm abducted to 90 degrees and the elbow flexed, the skin will be disinfected. After identifying coracoid process, high-frequency linear transducer is positioned just medial to the coracoid process and inferior to the clavicle in the parasagittal plane, scanning medially and laterally to identify the axillary artery. Once the artery has been identified, an attempt will be made to identify the hyperechoic cords of the brachial plexus and their corresponding positions relative to the artery.The needle then will be inserted in-plane from the cephalad end of the probe, with the insertion point just inferior to the clavicle. The needle, aimed toward the posterior aspect of the axillary artery and passes through the pectoralis major and minor muscles. Nerve stimulation with long (80-100mm) PNS needle will be used concurrently (0.5–0.8 mA, 0.1 m sec), the first motor response is often from the lateral cord (either elbow flexion or finger flexion). As the needle is advanced further beneath the artery, a posterior cord motor response may appear (finger and wrist extension). After careful aspiration, 1–2 mL of local anaesthetic will be injected to confirm proper needle placement and spread. The total drug volume should spread cephalad and caudal to cover the lateral and medial cords, respectively.
USG + PNS guided Retroclavicular approach The technique will be performed with the patient supine and the arm adducted. A high-frequency linear ultrasound transducer will be placed inferiorly to the clavicle just medially to the coracoid process in the parasagittal plane such that the axillary vessels and cords of the brachial plexus are viewed in cross-section. In this short axis view, the lateral cord appears in the anterocranial position, posterior cord in the posterocranial position, and median cord in the posterocaudal position. A needle insertion point is chosen in the supraclavicular fossa, between the clavicle and trapezius, so that the needle will pass behind the clavicle and enter the ultrasound image nearly parallel to the transducer (or perpendicular to the beam) and tip of the needle is directed near 5 or 6 o’clock position of axillary artery. A long (80-100mm) needle of PNS will be required given the distance from the supraclavicular fossa to the axillary artery. In this technique, the US probe is initially angled towards the clavicle to identify the needle approaching from behind the clavicle. After confirming with motor response as described in classical approach with PNS, 0.5% Levobupivacaine 15ml and 0.2% lignocaine 15ml will be given after negative aspiration.
OUTCOME MEASURES- Primary outcome: Comparison of performance time (time interval from the contact of the ultrasound probe with the patient to appreciate axillary artery to removal of the block needle) of Classical and Retroclavicular approaches. Secondary outcome: Needle visibility Needle passes To compare success rates ( patients requiring additional analgesia) To compare onset of sensory and motor block in both groups Complications
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