| CTRI Number |
CTRI/2018/05/013712 [Registered on: 07/05/2018] Trial Registered Retrospectively |
| Last Modified On: |
07/05/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Comparison Of Postoperative Analgesia Between Surgical Wound Site Infiltration and Ultrasound Guided Ilioinguinal Iliohypogastric Nerve Block Following Inguinal Hernia Repair |
|
Scientific Title of Study
|
Comparison Of Postoperative Analgesic Efficacy Between Surgical Wound Site Infiltration and Ultrasound Guided Ilioinguinal Iliohypogastric Nerve Block Following Inguinal Hernia Repair Under Spinal Anaesthesia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Karthika Rajan |
| Designation |
Senior Resident |
| Affiliation |
Seth GS Medical College and KEM Hospital |
| Address |
Department of Pediatric Anesthesia
Seth GS Medical College and KEM Hospital
Parel, Mumbai
Department of Pediatric Anesthesia
Seth GS Medical College and KEM Hospital
Parel, Mumbai
Mumbai
MAHARASHTRA
400012
India |
| Phone |
8078252358 |
| Fax |
|
| Email |
karthikarajan100@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Paul O Raphael |
| Designation |
Professor |
| Affiliation |
Amala Institute of Medical Sciences |
| Address |
Department Of Anaesthesiology
Amala Institute of Medical Sciences
Thrissur
Department Of Anaesthesiology
Amala Institute of Medical Sciences
Thrissur
Thrissur
KERALA
680555
India |
| Phone |
8281804916 |
| Fax |
|
| Email |
poloralph1965@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Paul O Raphael |
| Designation |
Professor |
| Affiliation |
Amala Institute of Medical Sciences |
| Address |
Department Of Anaesthesiology
Amala Institute of Medical Sciences
Thrissur
Department Of Anaesthesiology
Amala Institute of Medical Sciences
Thrissur
Thrissur
KERALA
680555
India |
| Phone |
8281804916 |
| Fax |
|
| Email |
poloralph1965@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology
Amala Institute of Medical Sciences
Amala Nagar
Thrissur
Kerala -680555 |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Amala Institute of Medical Sciences
Amala Nagar
Thrissur
Kerala-680555 |
| Type of Sponsor |
Private 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 Karthika Rajan |
Amala Institute of Medical Sciences |
Department of Anaesthesiology
Amala Institute of Medical Sciences
Amala Nagar
Thrissur
KERALA |
8078252358
karthikarajan100@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 |
Inguinal Hernia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ilioinguinal iliohypogastric nerve block |
using 10 ml of 0.25% Bupivacaine |
| Comparator Agent |
surgical wound site infiltration |
using 10 ml of 0.25% Bupivacaine |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and ASA 2 patients undergoing inguinal hernia repair under spinal anaesthesia |
|
| ExclusionCriteria |
| Details |
pregnant and lactating women
history of drug allergy to bupivacaine, chronic pain
bilateral inguinal hernia repair
refusal to consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. comparison of postoperative analgesia using visual analogue pain scale
2.comparison of time to first request of morphine in hours
3. comparison of total 24 hours consumption of morphine
|
0,0.5,1,2,4,6,12,24 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. comparison of vital signs
2. comparison nausea, vomiting, sedation using the four point categorical scale in the postoperative period |
0,0.5,1,2,4,6,12,24 hours |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/02/2015 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Background: Ultrasound guided ilioinguinal iliohypogastric nerve block has been reported to provide effective analgesia after lower abdominal surgeries but there are only very few data comparing it with surgical wound site infiltration with local anaesthesia in patients undergoing inguinal hernia repair under spinal anaesthesia Objectives: to compare the efficacy of Ultrasound guided ilioinguinal nerve block with surgical wound site infiltration for postoperative analgesia in inguinal hernia repair under spinal anaesthesia Method: prospective cohort study comprising of 50 patients undergoing inguinal hernia repair under spinal anaesthesia and has received ultrasound guided nerve block or surgical wound site infiltration with 10 ml of 0.25% bupivacaine.Quality of analgesia was compared in terms of Visual analogue scores (VAS) at 0,0.5,1,2,4,6,12,24 hours post operatively, morphine (rescue analgesic) consumption in first 24 hrs and time to first dose of morphine. other study parameters were nausea, vomiting,sedation score measured using 4 point categorical scale and consumption of ondansetron ( rescue antiemetic). Results: VAS scores were significantly lower in the nerve block group (p value <0.05).The morphine consumption was also significantly lower (p value<0.013) and the time to first dose of morphine was significantly longer (p value<0.0001) in the nerve block group.There was no significant difference in case of sedation nausea and vomiting and as a result the mean rescue antiemetic doses were comparable in both the groups. Conclusion: ultrasound guided ilioinguinal iliohypogastric nerve block provided better postoperative pain control than surgical wound site infiltration for inguinal hernia repair and therefore can be recommended as a part of multimodal analgesic regimen for the same
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