| CTRI Number |
CTRI/2015/08/006104 [Registered on: 18/08/2015] Trial Registered Retrospectively |
| Last Modified On: |
14/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Regional Anaesthesia for Inguinal Hernia Repair |
|
Scientific Title of Study
|
A comparative study of unilateral paravertebral block versus conventional spinal anaesthesia for inguinal hernia repair |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 8/2011 |
Protocol Number |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Yudhyavir brahmchari |
| Designation |
Post Graduate Student (MD, Anaesthesia) |
| Affiliation |
Lady Hardinge Medical college, New Delhi |
| Address |
Dept. of Anaesthesia,
Lady Hardinge Medical College, New Delhi- 110001
Central
DELHI
110001
India |
| Phone |
9811140057 |
| Fax |
|
| Email |
yudhyavir@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sunil kumar sinha |
| Designation |
Director Professor |
| Affiliation |
Lady Hardinge Medical college, New Delhi |
| Address |
Dept Of Anaesthesia
Lady Hardinge Medical college
New Delhi
Central
DELHI
110001
India |
| Phone |
9868493597 |
| Fax |
|
| Email |
sunilsinha248@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Yudhyavir brahmchari |
| Designation |
Post Graduate Student (MD, Anaesthesia) |
| Affiliation |
Lady Hardinge Medical college, New Delhi |
| Address |
Dept of anaesthesia
Lady Hardinge Medical college
New Delhi
Central
DELHI
110001
India |
| Phone |
9811140057 |
| Fax |
|
| Email |
yudhyavir@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lady Hardinge Medical college |
|
|
Primary Sponsor
|
| Name |
Lady Hardinge Medical Collee |
| Address |
Lady Hardinge Medical College
New Delhi |
| 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 |
| yudhyavir brahmchari |
Lady Hardinge Medical college |
Dept of Anaesthesia
Lady Hardinge Medical College
New Delhi
Central
DELHI |
9811140057
yudhyavir@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICAL COMMITTE, LADY HARDINGE MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
ASA grade I / II, (1) ICD-10 Condition: K639||Disease of intestine, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Spinal anaesthesia (SA) group. |
Patients in this group will be administered Spinal anaesthesia using midline approach with a 25G needle at L3-L4 or L2-L3 intervertebral space in the sitting position. The subarachanoid injection will contain 12.5 mg of 0.5% hyperbaric bupivacaine. After removing the spinal needle, the patients will be placed in a horizontal position for surgery. Sensory block will be assessed by pinprick and surgery will be allowed to commence when the sensory block was higher than T10 . Peak level of the sensory block will be also noted. Patients with inadequate surgical anaesthesia will be converted to GA and excluded from the study. |
| Intervention |
Unilateral Paravertebral block (PVB) Group. |
The PVB will be performed using a 22G Tuohy needle unilaterally with patient sitting at five level from T10 to L2 vertebrae. A point 2.5cm - 3 cm lateral to the superior aspect of the spinous process of T10 to L2 vertebrae will be marked as the point corresponding to the transverse process. Local injection of xylocaine 1% will be used at the site of needle insertion. After waiting for 3-5 min, the tuohy needle will be inserted perpendicularly to the skin, to depth of about 3-5 cm until the transverse process will be contacted.The needle will be then withdrawn a bit and walked off the transverse process and inserted 0.5 to 1 cm deeper to the inferior ridge of the transverse process. After negative aspiration for blood, 5 ml of bupivacaine(0.5%)+ 1:400,000 epinephrine will be injected at each segment. The onset of unilateral pinprick discrimination will be assessed every 5 min and thereafter, up to 30 min. The block will be considered as successful, if one following criteria is met-
(1) Onset of pinprick discrimination started within 15 min.
(2) Sensory block(T10-L2)achieved within maximum time of 30 min.
Absence of the onset of pinprick discrimination within 15 min will be considered as the block failure,the patient will be converted to GA and the case will be excluded from the study. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
Healthy patients ASA grade I & II
Male
Unilateral inguinal Hernia ( Indirect or direct with fully reducible) |
|
| ExclusionCriteria |
| Details |
Patients having known cardivascular, respiartory, renal, hepatic or metabolic disease, active gastriintestinal reflux, mental dysfunction, morbid obesity, history of substance abuse, chronic analgesic use and history of analgesic use and history of allergy to local anaesthetics and infections at the block site |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The duration of post-operative analgesia was higher in paravertebral (PVB) group as compared to the spinal anaesthesia (SA). Also shorter time taken to reach the discharge criteria for home readiness in PVB group as compared to SA group. |
Both assessed postoperatively at 2, 4, 6, 12 and 24 hrs |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The incidence of side effects such as PONV, headache and urinary cathertisation were higher in SA group as to PVB. Significant decrease in blood pressure seen in SA as compared to the PVB block . No significant changes seen in heart rate and oxygen saturation. |
Incidence of side effect observe post operatively for 24 hrs.
Hemodyanmic parameter - Baselie value, Immediately before block, Immediately after block, and then every three minutes for 1st 15 min and thereafter, at 10 min till the end of surgery |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/10/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The aim of study was to evaluate and compare the duration of postoperative analgesia, determine the time to reach the discharge criteria, asses the incidence of side effects such as nausea, vomiting, urinary retention and observe the hemodynamic parameter during intra-operative period. In our study we found prolonged postoperative analgesia, shorter time to reach the discharge criteria, lesser incidence of side effects and better hemodynamic stability in paravertebral group as compared to spinal anaesthesia. |