| CTRI Number |
CTRI/2017/02/007827 [Registered on: 10/02/2017] Trial Registered Retrospectively |
| Last Modified On: |
18/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of combination of two types of anaesthetic blocks for leg operations |
|
Scientific Title of Study
|
A study on evaluating the efficacy of psoas compartment block and sacral plexus block for lower limb surgeries. |
| Trial Acronym |
PCSPB |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vinod K |
| Designation |
Associate professor of Anesthesiology |
| Affiliation |
Shri sathya sai medical college and research institute,Chennai |
| Address |
Shri sathya sai medical college and research institute,Ammapettai,Kancheepuram district.
4/32,Second main road,M.G.R.Nagar, Velachery,Chennai
Chennai
TAMIL NADU
603108
India |
| Phone |
91-9841557566 |
| Fax |
|
| Email |
vinodkrishnagopal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod K |
| Designation |
Associate professor of Anesthesiology |
| Affiliation |
Shri sathya sai medical college and research institute,Chennai |
| Address |
Shri sathya sai medical college and research institute,Ammapettai,Kancheepuram district.
4/32,Second main road,M.G.R.Nagar, Velachery,Chennai
Chennai
TAMIL NADU
603108
India |
| Phone |
91-9841557566 |
| Fax |
|
| Email |
vinodkrishnagopal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinod K |
| Designation |
Associate professor of Anesthesiology |
| Affiliation |
Shri sathya sai medical college and research institute,Chennai |
| Address |
Shri sathya sai medical college and research institute,Ammapettai,Kancheepuram district.
4/32,Second main road,M.G.R.Nagar, Velachery,Chennai
Chennai
TAMIL NADU
603108
India |
| Phone |
91-9841557566 |
| Fax |
|
| Email |
vinodkrishnagopal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Shri Sathya Sai medical college and research institute,Ammapettai,Kancheepuram district,Pin-603108 |
|
|
Primary Sponsor
|
| Name |
Shri Sathya Sai medical college Research Institute |
| Address |
Ammapettai, Kancheepuram Dt.
Pin-603108 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Raghuraman M S |
42/101, D.L.F.Garden city,Thazhambur village,Navalur post,Chennai-603108 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vinod K |
Shri sathya sai medical college and research institute,Ammapettai. |
Department of Anesthesiology, Shri sathya sai medical college and research institute,Ammapettai,Kancheepuram district
Kancheepuram
TAMIL NADU |
91-9841557566
vinodkrishnagopal@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
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, Patients of less than 60 years of age undergoing lower limb operations, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
psoas compartment block,
sacral plexus block |
combination of psoas and sacral plexus block using 25 ml of 0.25 % bupivacaine hydrochloride |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
All ASA 1,2,3 patients undergoing unilateral lower limb operations were included |
|
| ExclusionCriteria |
| Details |
1)Extremes of age and BMI
2)Patients with coagulopathy
3)Patients with neuropathy
4)Severe cardiovascular and renal dysfunction
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Combination of psoas compartment and sacral plexus blocks was adequate in terms of motor and sensory block. |
Assessed at every five minutes from the time of blocks upto 40 minutes. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The patient and surgeon comfort, time of first analgesic dose and incidence of urinary retention were assessed. |
The patient and surgeon comfort were assessed using a two point scale at the end of the procedure 1)satisfactory 2)unsatisfactory.
Time of first analgesic dose was assessed in minutes from the time of end of second block to the time of first experience of pain by the patient in the post operative period.
Incidence of urinary retention was assessed whether the patient passed urine spontaneously or required catheterisation. |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
26/02/2016 |
| Date of Study Completion (India) |
31/07/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study was done on 101 adult patients, to evaluate the efficacy of the combination of psoas compartment and sciatic plexus block for lower limb operations after obtaining I.E.C approval. One case was excluded. We observed that the combination of these two blocks was effective and safe. |