| CTRI Number |
CTRI/2023/06/054154 [Registered on: 20/06/2023] Trial Registered Prospectively |
| Last Modified On: |
19/06/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A clinical trial to compare two methods of giving Lumbosacral Plexus Block, one using both ultrasound and peripheral nerve stimulator, and the other using peripheral nerve stimulator alone, for pain relief to patients after lower limb surgery |
|
Scientific Title of Study
|
Evaluation of ultrasound assisted peripheral nerve stimulator guided versus peripheral nerve stimulator guided lumbosacral plexus block for postoperative analgesia in patients undergoing lower limb surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Veena Chatrath |
| Designation |
Professor and Head, Department of Anaesthesia, Government Medical College, Amritsar |
| Affiliation |
Government Medical College, Amritsar |
| Address |
Department of Anaesthesia,
Government Medical College,
Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9814112355 |
| Fax |
|
| Email |
drveenachatrath@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Veena Chatrath |
| Designation |
Professor and Head, Department of Anaesthesia, Government Medical College, Amritsar |
| Affiliation |
Government Medical College, Amritsar |
| Address |
Department of Anaesthesia,
Government Medical College,
Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9814112355 |
| Fax |
|
| Email |
drveenachatrath@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veena Chatrath |
| Designation |
Professor and Head, Department of Anaesthesia, Government Medical College, Amritsar |
| Affiliation |
Government Medical College, Amritsar |
| Address |
Department of Anaesthesia,
Government Medical College,
Amritsar
Amritsar
PUNJAB
143001
India |
| Phone |
9814112355 |
| Fax |
|
| Email |
drveenachatrath@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia,
Government Medical College,
Circular Road,
Amritsar
Punjab
143001
India |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesia |
| Address |
Government Medical College,
Amritsar |
| Type of Sponsor |
Government medical college |
|
|
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 Alisha Gupta |
Government Medical College, Amritsar |
Department of Anaesthesia
Amritsar
PUNJAB |
8283900864
gupta.alisha2498@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Government Medical College, Amritsar |
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 |
Peripheral nerve stimulator guided lumbosacral plexus block |
We will give peripheral nerve stimulator guided lumbosacral plexus block for postoperative analgesia to 30 patients (Group P) after lower limb surgery under spinal anaesthesia. Various parameters will be noted and compared with the other group. Total duration of intervention is from the start of procedure till 24 hours postoperative period. |
| Intervention |
Ultrasound assisted peripheral nerve stimulator guided lumbosacral plexus block |
We will give ultrasound assisted peripheral nerve stimulator guided lumbosacral plexus block for postoperative analgesia to 30 patients (Group U) after lower limb surgery under spinal anaesthesia. Various parameters will be noted and compared with the other group. Total duration of intervention is from the start of procedure till 24 hours postoperative period. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to ASA grade I and II
Patients undergoing elective unilateral lower limb surgery
Patients with normal neurological status
Co-operative patients |
|
| ExclusionCriteria |
| Details |
Refusal by patient for the procedure or to enlist in study
Patients belonging to ASA grade III or IV
Patients with coagulation disorders or on anticoagulation therapy
Patients with history of allergy to local anaesthetic drugs
Local infection at the site of block
Patients with known neuropathies
Morbidly obese patients
Pregnant females
Patients undergoing bilateral lower limb surgery |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Procedural Time (Time required to complete the block)
Duration of sensory block
Total dose of rescue analgesia in 24 hours
Number of pricks taken in each block |
Time from start of procedure till 24 hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Haemodynamic changes
Side effects & complications including number of inadvertent vessels punctured
Patient satisfaction score
Surgeon satisfaction score |
Time from start of procedure till 24 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
01/07/2023 |
| 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 |
|
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
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a prospective, randomized, parallel group trial comparing the efficacy of ultrasound assisted peripheral nerve stimulator guided versus peripheral nerve stimulator guided lumbosacral plexus block (LPSB) for postoperative analgesia in terms of patient satisfaction, time taken for the procedure, ease of administration, number of pricks, duration of analgesia, postoperative analgesic requirement and haemodynamic parameters associated with the procedure in patients undergoing elective unilateral lower limb surgery. The study will be conducted in Government Medical College, Amritsar on 60 ASA grade I-II patients of either sex in the age group of 20 to 60 years scheduled for lower limb orthopaedic surgery under spinal anaesthesia, randomly divided into two groups of 30 patients each- Group ’U’ will receive LSPB using ultrasound assisted peripheral nerve stimulator guided technique and Group ’P’ will receive LSPB using peripheral nerve stimulator guided technique. The data thus obtained will be analyzed and compared statistically. |