| CTRI Number |
CTRI/2025/04/084254 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
05/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Study of Incidence of Hemidiaphragmatic paralysis in two approaches of ultrasound guided Brachial plexus block: Supraclavicular and Costoclavicular |
|
Scientific Title of Study
|
Incidence of Hemidiaphragmatic Paralysis in Brachial Plexus Block with Supraclavicular approach versus Costoclavicular approach in patients undergoing upper limb surgery- A Prospective Randomized Comparative Study |
| 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 Prateek Singh Bais |
| Designation |
Associate Professor |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow |
| Address |
Department Of Anaesthesiology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Lucknow
Lucknow UTTAR PRADESH 226014 India |
| Phone |
8601339323 |
| Fax |
|
| Email |
prateek.bais.lko@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Prashansa Attri |
| Designation |
PG student |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow |
| Address |
Department Of Anaesthesiology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow
Lucknow UTTAR PRADESH 226014 India |
| Phone |
7017819263 |
| Fax |
|
| Email |
dr.prashansa03@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Prateek Singh Bais |
| Designation |
Associate Professor |
| Affiliation |
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow |
| Address |
Department Of Anaesthesiology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow
Lucknow UTTAR PRADESH 226014 India |
| Phone |
8601339323 |
| Fax |
|
| Email |
prateek.bais.lko@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India 226014 |
|
|
Primary Sponsor
|
| Name |
Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow Uttar Pradesh India |
| Address |
Department Of Anaesthesiology Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow Uttar Pradesh India 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 Prateek Singh Bais |
Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India 226014 |
Department Of Anaesthesiology, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, India 226014 Lucknow UTTAR PRADESH |
8601339323
prateek.bais.lko@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 |
| Intervention |
Incidence of Hemidiaphragmatic Paralysis in Brachial Plexus Block with costoclavicular approach using 25 ml of 0.75% ropivacaine + 2% lignocaine in 1:1 ratio
|
Costoclavicular block using 25 ml of 0.75% ropivacaine + 2% lignocaine in 1:1 ratio After 20 mins, sensory and motor effect of the block will be checked. At 25 mins, patient will be assessed for baseline parameters of diaphragmatic function: Diaphragmatic excursion, Diaphragm thickening fraction under ultrasound guidance, Breath holding test, Cough test and Spirometry will be performed. |
| Comparator Agent |
Incidence of Hemidiaphragmatic Paralysis in Brachial Plexus Block with supraclavicular approach using 25 ml of 0.75% ropivacaine + 2% lignocaine in 1:1 ratio |
Supraclavicular block using 25 ml of 0.75% ropivacaine + 2% lignocaine in 1:1 ratio
After 20 mins, sensory and motor effect of the block will be checked.
At 25 mins, patient will be assessed for baseline parameters of diaphragmatic function: Diaphragmatic excursion, Diaphragm thickening fraction under ultrasound guidance, Breath holding test, Cough test and Spirometry will be performed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients willing to give written and informed consent
Age group: 18- 65 years
Both genders
American Society of Anaesthesiologists (ASA) physical status I or II patients
Scheduled for upper limb surgeries (including elbow, forearm, hand, and wrist surgery)
|
|
| ExclusionCriteria |
| Details |
Patient refusal
BMI more than 30kg/m2
Hypersensitivity to local anaesthetics
Pre-existing neuropathy on surgical limb
Significant pulmonary disease
Coagulopathy, sepsis, infection on block site
Conversion to general anaesthesia
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Incidence of hemidiaphragmatic paralysis in brachial plexus block with supraclavicular vs costoclavicular approach |
25 minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess pulmonary function before & after the block using spirometer, breath holding test & cough test
2. To assess scan time & needle time in minutes in two approaches
3. To assess post operative pain using numerical rating scale
4. Time to first rescue analgesia
5. Any adverse events/ complications will be noted |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="70" Sample Size from India="70"
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)
|
16/04/2025 |
| 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="5" Days="30" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Upper limb orthopaedic surgeries have shown to fasten and improve clinical outcome of trauma patients. Brachial plexus block is an established mode of anaesthesia and analgesia in upper limb orthopaedic procedures. Hemidiaphragmatic Paralysis (HDP) is a frequent complication of brachial plexus block performed with supraclavicular approach as a result of unintentional blockade of phrenic nerve. It is well tolerated in healthy patients, but can become a critical issue in patients with compromised pulmonary function. Costoclavicular brachial plexus block is an emerging, recently introduced infraclavicular approach, exhibiting an accelerated and reliable blockade. The compact organization of plexus at this level is advantageous as lesser volumes of local anaesthetic is required compared to other approaches of infraclavicular block. In our proposed study we aim to compare incidence of hemidiaphragmatic paralysis in brachial plexus block with supraclavicular approach vs costoclavicular approach. Primary objective is to compare the incidence of hemidiaphragmatic paralysis by assessing diaphragmatic function with diaphragm excursion and diaphragm thickness fraction (DTF) using ultrasound and Secondary objectives are: to assess pulmonary function before and after the block using spirometer, breath holding test and cough test, scan time and needle time in minutes, post operative pain using numerical rating scale (NRS), time to first rescue analgesia and any complication/adverse events will be noted. Following approval from the Institutional Ethics Committee and registering the trial in CTRI and after obtaining written and informed consent from the patients, a prospective randomized comparative study will be conducted will be conducted in Apex Trauma Centre, SGPGIMS. over a period of 18 months. Patients will undergo pre anaesthetic check up and will be prepared as per standard anesthesia practices. Patients will be randomly divided into two groups Group 1: Brachial plexus block using Costoclavicular approach Group 2: Brachial plexus block using Supraclavicular approach Patient will be shifted in the operating room, all routine ASA standard monitors, IV line and supplemental oxygen will be attached. Baseline parameters of diaphragmatic function: Diaphragmatic excursion, Diaphragm thickening fraction under ultrasound guidance, Breath holding test, Cough test and Spirometry will be performed. Blocks will be performed under ultrasound guidance using 25 ml of local anesthetic containing 0.75% ropivacaine and 2% lignocaine in (1:1), scan time and needle time will be noted simultaneously. After 20 mins, sensory and motor effect of the block will be checked. At 25 mins, patient will be reassessed for the same baseline parameters and any obvious discomfort, adverse events, complications such as pneumothorax, vascular puncture, local anaesthetic systemic toxicity, hematoma, and Horner’s syndrome will be recorded, if present it will be treated accordingly and the patient will be excluded from the trial. If absent, the patient will be handed over to the surgical team for intervention. IV sedation using dexmedetomidine (loading dose 1mcg/kg over 10 mins, maintenance dose of 0.5mcg/kg/hr) will be started and continued intraoperatively. After completion of surgery, patient will be shifted to Post Operative ICU for observation. NRS scores for pain and time of requirement of first rescue analgesia will be recorded. Any complications in intraoperative and postoperative period will be noted and intervention will be done accordingly.
|