| CTRI Number |
CTRI/2019/02/017854 [Registered on: 27/02/2019] Trial Registered Prospectively |
| Last Modified On: |
25/02/2019 |
| 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 quality of pain relief between ultrasound guided injection of local anaesthetic near thoracic paravertebral space and one sided spinal anaesthesia in patients undergoing open inguinal hernia surgery |
|
Scientific Title of Study
|
Comparison of post operative analgesia between ultrasound guided paravertebral block and unilateral spinal anaesthesia in patients undergoing open inguinal hernia repair |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr FANTIN JOEL CALINGARAYAR |
| Designation |
Post graduate |
| Affiliation |
PGIMER AND DR RML HOSPITAL |
| Address |
DEPEARTMENT OF ANAESTHESIOLOGY
PGIMER AND DR RML HOSPITAL
type 3 presidential estate NEW DELHI 110001
Type 3 presidential estate New Delhi 110001
Central
DELHI
110001
India |
| Phone |
8610964671 |
| Fax |
|
| Email |
fantinjoel@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr NAMITA ARORA |
| Designation |
Associate professor |
| Affiliation |
PGIMER AND RML HOSPITAL |
| Address |
180 mandakini enclave Alaknanda New Delhi 110019
Dept of anaesthesia type 3 presidential estate
New Delhi
110001
Central
DELHI
110001
India |
| Phone |
9868219619 |
| Fax |
|
| Email |
namitaarora16@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr NAMITA ARORA |
| Designation |
Associate professor |
| Affiliation |
PGIMER AND RML HOSPITAL |
| Address |
180 mandakini enclave Alaknanda New Delhi 110019
Dept of anaesthesia type 3 presidential estate
New Delhi
110001
Central
DELHI
110001
India |
| Phone |
9868219619 |
| Fax |
|
| Email |
namitaarora16@yahoo.com |
|
|
Source of Monetary or Material Support
|
| PGIMER AND DR RML HOSPITAL
Department of anaesthesiology
Type 3 presidential estate
New Delhi 110001 |
|
|
Primary Sponsor
|
| Name |
PGIMER AND DR RML HOSPITAL NEW DELHI |
| Address |
Type 3 presidential estate
New Delhi 110001 |
| 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 FANTIN JOEL CALINGARAYAR |
PGIMER AND DR RML HOSPITAL |
DEPARTMENT OF ANAESTHESIOLOGY ROOM NO 304 PGIMER BUILDING Type 3 presidential estate
New Delhi 110001
Central
DELHI |
8610964671
fantinjoel@ymail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Pgimer and Dr RML HOSPITAL NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ULTRASOUND GUIDED PARAVERTEBRAL BLOCK |
At T-10 level 15ml of 0.5% Bupivacaine
At L-1 level 5ml of 0.5% Bupivacaine |
| Comparator Agent |
UNILATERAL SPINAL ANAESTHESIA |
At level of L2-3 or L 3-4 1.6 mL of hyperbaric bupivacaine 0.5% |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
1.Undergoing elective unilateral open inguinal hernia repair
2. ASA PHYSICAL STATUS I and II
|
|
| ExclusionCriteria |
| Details |
1. Morbid obesity (BMI > 35 kg/m2).
2. Coagulopathy.
3. History of substance abuse.
4. Allergy to local anesthesia.
5. Mental dysfunction.
6. Contraindication to spinal anaesthesia. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| I. Time to 1st rescue analgesic |
In 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total rescue analgesic consumption.
|
In first 24 hours |
| To observe post-operative nausea vomiting and urinary retention. |
In 24 hours |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
24/03/2019 |
| 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 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)?
|
|
Brief Summary
|
It is a Randomized Single Blinded Comparative Study taking place in DEPARTMENT OF ANAESTHSIOLOGY, PGIMER AND RML HOSPITAL , NEW DELHI . A total of 50 patients undergoing unilateral inguinal hernia repair is included in the study and divided into two groups 25 in each group.The ultrasound guided paravertebral block is given at T-10 and L -1 levels with 15ml of 0.5% Bupivacaine and 5ml of 0.5% bupivacaine respectively and in other group unilateral spinal anaesthesia is given at the level of L2-3 or L 3-4 with 5ml of 0.5% Bupivacaine is given. Primary outcome is Time to 1st rescue analgesic and the secondary outcomes are Total rescue analgesic consumption in first 24 hrs and to observe post-operative nausea vomiting and urinary retention. The duration of the study is from 1st November 2018 to 31st March 2020. |