| CTRI Number |
CTRI/2025/03/083201 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
24/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Study the Efficacy of ropivacaine 0.2percentage vs ropivacaine 0.2percentage with nalbuphine for post operative analgesia in appendicectomy patients by transversus abdominis plane block |
|
Scientific Title of Study
|
To Study the Efficacy of Ropivacaine 0.2 percentage vs Ropivacaine 0.2 percentage with
Nalbuphine for Post operative Analgesia in appendicectomy patients by
Transversus Abdominis Plane Block |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Parshant Bansal |
| Designation |
Junior resident |
| Affiliation |
Shri Bhausaheb Hire Government Medical college |
| Address |
Room no 16,Department of Anesthesia Shri bhausaheb hire government medical college,Dhule,Maharashtra
Dhule
MAHARASHTRA
424311
India |
| Phone |
7009766321 |
| Fax |
|
| Email |
bansalparshant98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSandipbhai Patel |
| Designation |
Associate Professor |
| Affiliation |
Shri Bhausaheb Hire Government Medical college |
| Address |
Room no 16,Department of Anesthesia,Shri Bhausaheb Hire Government Medical college,Dhule
Dhule
MAHARASHTRA
424311
India |
| Phone |
9850878200 |
| Fax |
|
| Email |
sandip2027@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DrSandipbhai Patel |
| Designation |
Associate Professor |
| Affiliation |
Shri Bhausaheb Hire Government Medical college |
| Address |
Room no 16,Department of Anesthesia,Shri Bhausaheb Hire Government Medical college,Dhule
Dhule
MAHARASHTRA
424311
India |
| Phone |
9850878200 |
| Fax |
|
| Email |
sandip2027@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Shri bhausaheb hire government medical college,Dhule 424311 |
|
|
Primary Sponsor
|
| Name |
Parshant bansal |
| Address |
Shri bhausaheb hire government medical college,Dhule 424311 |
| 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 |
| DrParshant bansal |
Shri bhausaheb hire government medical college |
Room no 16,Department of Anaesthesia
Dhule
MAHARASHTRA |
7009766321
bansalparshant98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Shri bhausaheb hire government medical college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K353||Acute appendicitis with localizedperitonitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
ropivacaine0.2% vs ropivacaine 0.2% with nalbuphine |
Patient will divided randomly to receive TAP block either with 0.2% ropivacaine 20ml or TAP block with 0.2% ropivacaine 20ml with Nalbuphine 2.5mg |
| Intervention |
Transversus abdominis plane block |
the patient is placed in the supine position. After standard aseptic precautions, a blunt-tip 22-gauge, 80–100 mm short-bevel needle is inserted perpendicular to the skin at the midpoint between the iliac crest and the costal margin along the mid-axillary line. The needle passes through the subcutaneous tissue and external oblique aponeurosis, followed by two distinct “pops” or fascial clicks, indicating passage through the external oblique fascia and then the internal oblique fascia into the transversus abdominis plane. After confirming negative aspiration for blood, 20mL of 0.2% ropivacaine is injected incrementally into this plane. A characteristic resistance followed by an ease of injection suggests correct deposition in the fascial plane. Care is taken to aspirate intermittently and monitor for signs of local anesthetic systemic toxicity (LAST).
|
|
|
Inclusion Criteria
|
| Age From |
21.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with American society of Anaesthiologist’s physical status class 1&2
2.Patients posted for uncomplicated open Appendicectomy surgeries
3.Patients aged between 21-65 years of both genders who upon being explained the procedure are willing to participate in the study |
|
| ExclusionCriteria |
| Details |
1. complicated appendectomies
2. Appendicular mass/abscess.
3. Skin infection at Puncture site.
4. Allergy to local anaesthetics.
5. Preoperative opioid and non-steroidal drug treatment for chronic pain treatment
6. Patients with blood dyscrasias, use of introoperative opiate analgesics, patients with significant hepatic, renal, cardiovascular, pulmonary, metabolic, psychiatric disorders |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Post operative pain score(visual analog score-VAS) will be assessed
2. to study postoperative Analgesic duration, and analgesic pattern with 0.2%Ropivacaine
3. To study, post operative analgesic duration, and analgesic pattern with 0.2% Ropivacaine with Nalbuphine
|
30min,1 hr,4hr,8hr,12hr,16hr,20hr and 24hr. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To study, side-effects, if any.
2)To study additional post-operative analgesic requirement |
first 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)
|
04/04/2025 |
| 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="0"
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 - NO
|
|
Brief Summary
|
Regional anaesthesia techniques are gaining more acceptance as a part of multi model analgesia. Multimodal analgesia includes use of opioids,non steroidal anti-inflammatory drugs, paracetamol infusion and regional anaesthetic techniques such as epidural block, local infiltration or nerve blocks. Also high doses of opioids cause significant risks such as post-operative nausea and vomiting, Sedation, sleep disturbances, urinary retention and respiratory depression in post-operative patients. By effectively managing post-operative pain with proper analgesia helps to attenuate surgical stress response, decreased perioperative morbidity and improves surgical outcome. Peripheral Nerve blocks such as transversus abdominis plane (TAP) block have been described in the literature as means to alleviate pain due to abdominal wall incision.
|