| CTRI Number |
CTRI/2019/03/018097 [Registered on: 15/03/2019] Trial Registered Prospectively |
| Last Modified On: |
26/02/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between different nerve blocks for post operative pain relief after Inguinal Hernia Surgeries |
|
Scientific Title of Study
|
Comparing efficacy of Transversus Abdominis Plane and Ilioinguinal Iliohypogastric nerve blocks for post op analgesia in Inguinal Hernia Surgeries under Sub Arachinoid Block |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anup Gohatre |
| Designation |
JR |
| Affiliation |
IMS, BHU |
| Address |
Institute of Medical Sciences,
Banaras Hindu University,
Varanasi
Institute of Medical Sciences,
Banaras Hindu University,
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9403173892 |
| Fax |
5422369003 |
| Email |
anup.gohatre@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S K Mathur |
| Designation |
Professor and HOD |
| Affiliation |
IMS, BHU |
| Address |
Institute of Medical Sciences,
Banaras Hindu University,
Varanasi
Institute of Medical Sciences,
Banaras Hindu University,
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9450955143 |
| Fax |
5422369003 |
| Email |
skmathurbhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anup Gohatre |
| Designation |
JR |
| Affiliation |
IMS, BHU |
| Address |
Institute of Medical Sciences,
Banaras Hindu University,
Varanasi
Institute of Medical Sciences,
Banaras Hindu University,
Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9403173892 |
| Fax |
5422369003 |
| Email |
anup.gohatre@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institute of Medical Sciences,
Banaras Hindu University,
Varanasi |
|
|
Primary Sponsor
|
| Name |
Dr Anup Gohatre |
| Address |
Department of Anaesthesiology,
IMS, BHU,
Varanasi |
| Type of Sponsor |
Other [Investigator] |
|
|
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 Anup Gohatre |
IMS, BHU |
Department of Anaesthesiology,
IMS, BHU,
Varanasi
Varanasi
UTTAR PRADESH |
9403173892
5422369003
anup.gohatre@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee, Faculty of Medicine, Institute of Medical Sciences, Banaras Hindu University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K409||Unilateral inguinal hernia, without obstruction or gangrene, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Ilioinguinal and Iliohypogastric nerve block |
Group II (40 patients) will be given ultrasound guided II-IH block with 20 ml of 0.25% bupivacaine. |
| Intervention |
Transverses Abdominis Plane block (TAP) block |
Group I (40 patients) will be given ultrasound guided TAP block with 20 ml of 0.25% bupivacaine. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients belonging to American Society of Anesthesiologist (ASA) Grade- I & II, Weighing 40 to 80 Kgs, above 18 years of age, of both the sexes and undergoing elective open inguinal hernia repair surgery under spinal anesthesia. |
|
| ExclusionCriteria |
| Details |
Patients not giving consent to the study, Age ≤18 yr BMI ≥40 kg m-2
Skin infection at the puncture site Contraindication to LA agents Chronic hepatic or liver failure
Preoperative opioid or non-steroidal anti-inflammatory drugs treatment for chronic pain Patient Refusal |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time of request of first rescue analgesia
Amount of IV Diclofenac sodium
VAS score, at rest, as well as on movement. |
At 4hrs, 24hrs and 48hrs. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Complications related with SAB, Urinary retention and leg weakness.
Procedure related complications, such as hematoma, bleeding, loss of sensation and infections. |
At 4 hrs, 12 hrs and 24 hrs. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "68"
Final Enrollment numbers achieved (India)="68" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/03/2019 |
| Date of Study Completion (India) |
30/06/2020 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Inguinal hernia repair is commonly performed under spinal anesthesia. Inadequate postoperative analgesia is one of the most common causes of poor patient satisfaction. Abdominal field blocks like Transversus Abdominis Plane (TAP) block and Ilioinguinal-Iliohypogastric nerve (II-IH) blocks, because of technical simplicity, opioid-sparing effects, and prolonged pain relief, are the upcoming promising techniques of management of postoperative pain for lower abdominal surgeries. This randomized prospective study will be carried out on 80 adult patients of ASA physical status I and II, scheduled for elective open inguinal hernia repair surgeries under spinal anesthesia. After the approval by the institutional Ethical Committee, written informed consent will be obtained from all the patients before being included in the study. They will be randomly allocated to following groups of 40 each: Group TAP: Ultrasound-guided TAP block will be given with 20 ml of 0.25% bupivacaine. Group II-IH: Conventional II-IH block will be given with 16 ml of 0.25% bupivacaine. Time of return of sensation after weaning of spinal anesthesia and time of request of first rescue analgesia will be recorded in all the patients. Amount of i.v. analgesics used in PACU, POD1, POD2. VAS score at rest (VASr) before discharge from PACU, and 4 and 12 h after surgery and VAS score at rest (VASr) as well as on movement (VASm) on the first postoperative day (POD1) and POD2 will be, and 3 and 6 months after surgery will be obtained. LA complication, if any, and urinary retention and leg weakness will be recorded |