| CTRI Number |
CTRI/2024/11/076103 [Registered on: 01/11/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of two drugs for pain relief in hernia surgeries |
|
Scientific Title of Study
|
Comparison of efficacy of Nalbuphine-Levobupivacaine combination with Levobupivacaine alone in ultrasound guided Transversus Abdominis Plane block in open inguinal hernia repair surgeries : A randomised control trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Himanshi Singh |
| Designation |
PG resident |
| Affiliation |
Ananta institute of medical sciences and research centre, Nathdwara, Rajsamand |
| Address |
Room no 2040, Department of Anaesthesia, OT complex, second floor, Ananta institute of medical sciences and research centre, NH 08, village Kaliwas, Nathdwara, Rajsamand
Rajsamand RAJASTHAN 313202 India |
| Phone |
9660550323 |
| Fax |
|
| Email |
drhimanshi31@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sakshi |
| Designation |
Assistant professor |
| Affiliation |
Ananta institute of medical sciences and research centre, Nathdwara, Rajsamand |
| Address |
Room no 2040, Ananta institute of medical sciences and research centre, NH 08, village Kaliwas, Nathdwara, Rajsamand
Rajsamand RAJASTHAN 313202 India |
| Phone |
9571241824 |
| Fax |
|
| Email |
drsakshiarora88@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sakshi |
| Designation |
Assistant professor |
| Affiliation |
Ananta institute of medical sciences and research centre, Nathdwara, Rajsamand |
| Address |
Room no 2040, Department of Anaesthesia, OT complex, second floor, Ananta institute of medical sciences and research centre, NH 08, village Kaliwas, Nathdwara, Rajsamand
RAJASTHAN 313202 India |
| Phone |
9571241824 |
| Fax |
|
| Email |
drsakshiarora88@gmail.com |
|
|
Source of Monetary or Material Support
|
| Ananta institute of medical sciences and research centre, Nathdwara, Rajsamand, Rajasthan, India
PIN code 313202 |
|
|
Primary Sponsor
|
| Name |
Himanshi Singh |
| Address |
Room no 2040, Ananta institute of medical sciences and research centre, NH 08, village Kaliwas, Nathdwara, Rajsamand |
| Type of Sponsor |
Other [Self] |
|
|
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 Sakshi |
Ananta institute of medical sciences and research centre |
Room no 2040, Department of Anaesthesia, OT complex, second floor, Ananta institute of medical sciences and research centre, NH 08, Village Kaliwas, Nathdwara, Rajsamand Rajsamand RAJASTHAN |
9571241824
drsakshiarora88@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ananta IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Levobupivacaine |
20ml Levobupivacaine 0.25% +1 ml Normal Saline given in TAP block. |
| Comparator Agent |
Levobupivacaine with Nalbuphine |
20ml Levobupivacaine 0.25% + 10mg (1ml) Nalbuphine given in TAP block |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Informed consent, all patients undergoing unilateral open inguinal hernioplasty, ASA class 1 and 2 |
|
| ExclusionCriteria |
| Details |
ASA grade III and IV, Allergy to the study drug, Communication difficulties being unable to comprehend visual analogue scale, Bleeding diathesis, Patients with deranged liver and kidney functions, BMI less than 18 and more than 35, Surgery duration of more than 2 hours |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the time of first rescue analgesic (duration of analgesia)
|
0 mintues, 30 min, 60 min, 90 min, 120 min, 4 hours, 8 hours, 12 hours, 16 hours, 20 hours, 24 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To observe the visual analogue score (resting and ambulatory) for 24 hours, total number of analgesics required in 24 hours, to assess the haemodynamic parameters postoperatively, to observe the side effects |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
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)
|
04/11/2024 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan Response - Informed Consent Form Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drhimanshi31@gmail.com].
- For how long will this data be available start date provided 14-10-2026 and end date provided 14-01-2027?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
Pain after open Hernia Repair surgeries can be moderate to severe and may be associated with prolonged hospital stay, increase in sympathetic activity leading to increase in heart rate, blood pressure, respiratory rate and even delirium. Transversus Abdominis Plane (TAP) Block is a recent modality used for postoperative analgesia with minimal side effects in Inguinal Hernia Repair surgeries. A local anaesthetic solution is deposited between the plane of Internal Oblique (IO) and Transversus Abdominis (TA) muscles. The efficacy of Nalbuphine has been explored as an adjuvant to other drugs in central neuraxial blocks by epidural, caudal and intrathecal routes. But there is limited data of use of Nalbuphine in combination with Levobupivacaine in TAP block. So this study is planned to evaluate the analgesic efficacy of Nalbuphine with Levobupivacaine and Levobupivacaine alone in TAP block in hernia surgeries. The aim of the present study is to compare the analgesic efficacy of Nalbuphine with Levobupivacaine versus Levobupivacaine alone in TAP block in Inguinal Repair Hernia surgeries. The objective is to assess the time of first rescue analgesic (duration of analgesia), to observe the visual analogue score (VAS) (resting and ambulatory) for 24 hours, total number of analgesics required in 24 hours, to assess the haemodynamic parameters postoperatively and to observe the side effects.
|