| CTRI Number |
CTRI/2023/12/060896 [Registered on: 28/12/2023] Trial Registered Prospectively |
| Last Modified On: |
26/12/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of two concentrations of a drug in management of pain after brain surgery
|
|
Scientific Title of Study
|
A Randomized controlled study to assess the efficacy of ropivacaine instillation through subgaleal drain for postcraniotomy pain
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Priyanka Bhardwaj |
| Designation |
Junior Resident |
| Affiliation |
Uttar pradesh university of medical sciences Saifai, Etawah |
| Address |
Room number-329 Department of Anaesthesiology and Critical Care, UPUMS,Saifai,Etawah.
Etawah
UTTAR PRADESH
206130
India |
| Phone |
8317061982 |
| Fax |
|
| Email |
drdrbhardwaj123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Usha Shukla |
| Designation |
Professor and Head of department |
| Affiliation |
Uttar pradesh medical sciences saifai,etawah |
| Address |
Room number-329 Department of Anaesthesiology and Critical Care, UPUMS,Saifai,Etawah.
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9412201915 |
| Fax |
|
| Email |
ushashukla1970@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Priyanka Bhardwaj |
| Designation |
Junior Resident |
| Affiliation |
Uttar pradesh medical sciences saifai,etawah |
| Address |
Room number-329 Department of Anaesthesiology and Critical Care, UPUMS,Saifai,Etawah.
Etawah
UTTAR PRADESH
206130
India |
| Phone |
8317061982 |
| Fax |
|
| Email |
drdrbhardwaj123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Uttar pradesh university of medical sceinces,Saifai,Etawah. |
|
|
Primary Sponsor
|
| Name |
Uttar pradesh university of medical sceinces saifai etawah |
| Address |
Uttar pradesh university of medical sceinces saifai etawah.
Pincode 206130 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Priyanka Bhardwaj |
Uttar Pradesh University of Medical Sciences |
Room no.329, Department of Anaesthesiology and Critical Care,UPUMS,Saifai,Etawah pincode-206130
Etawah
UTTAR PRADESH |
8317061982
drdrbhardwaj123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES, SAIFAI, ETAWAH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G891||Acute pain, not elsewhere classified, (2) ICD-10 Condition: C713||Malignant neoplasm of parietal lobe, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GROUP A |
0.9% NS(12ml),Once at the time of dural closure,Instillation through subgaleal drain,Total duration of recording data will be 24 hours
|
| Intervention |
GROUP B |
0.1% Ropivacaine(12ml),Once at the time of dural closure,Instillation through subgaleal drain,Total duration of recording data will be 24 hours |
| Intervention |
GROUP C |
0.2% Ropivacaine(12ml),Once at the time of dural closure,Instillation through subgaleal drain,Total duration of recording data will be 24 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. American society of anaesthesiologists (ASA)
Physical Status Grade I and II
2. Elective Craniotomy |
|
| ExclusionCriteria |
| Details |
1. Patient refusal
2. Previous Head trauma
3. History of craniotomy
4. Chronic headache (migraine and cluster headache)
5. Glasgow Coma scale (GCS) <13
6. Active psychiatric disorders
7. Allergy to study drugs
8. Chronic opioid/analgesic abuse
9. Chronic steroid use
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Assess postoperative pain by NRS (Numeric Rating Scale)
|
From 0 minute to 24 hours
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare the duration of analgesia.
2.To compare the rescue analgesic requirement in 24 hours postoperatively.
3.To compare the postoperative hemodynamic parameters such as Systolic blood pressure (SBP), Diastolic blood pressure (DBP), Mean arterial pressure (MAP), Oxygen saturation (SPO2) in percentage.
4.To compare the patient satisfaction score.
|
From 0 minute to 24 hours |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Phase 4 |
|
Date of First Enrollment (India)
|
05/01/2024 |
| 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="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 - 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 [drdrbhardwaj123@gmail.com].
- For how long will this data be available start date provided 01-07-2025 and end date provided 30-06-2030?
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
|
Title of this study is A randomized controlled study to assess the efficacy of ropivacaine instillation through subgaleal drain for postcraniotomy pain. Majority of patients experiences moderate-to-severe pain after craniotomy. Wound instillation of local anaesthetic drugs as a modality for postoperative pain management has proved quite useful in surgeries such as spine surgeries, laparoscopy, mastectomy, hysterectomy and caesarean section. Various local anaesthetic (LA) drugs such as bupivacaine, levobupivacaine and ropivacaine have been studied for this technique. Ropivacaine is long- acting and exhibits differential blockade predominantly on sensory nerve fibres. It has been successfully and safely used in neurosurgical patients for local infiltration at pin sites, incision site and scalp block. Ropivacaine has better safety profile among all these drugs and had been studied its instillation via subgaleal drains in 0.25% concentration. As there is no study comparing the effect of low concentration of ropivacaine instillation through subgaleal drain so we planned to study the efficacy of low concentrations of ropivacaine such as 0.1% and 0.2% through subgaleal drain for postcraniotomy pain. Aim of this study is to assess the efficacy of ropivacaine instillation through subgaleal drain for post craniotomy pain in patients undergoing elective craniotomy. Objective is to assess postoperative pain by NRS (Numeric Rating Scale) and to compare the duration of analgesia. In this study we will instill the 12ml of 0.1 % and 0.2% ropivacaine through subgaleal drain in post craniotomy patients at the time of dural closure. The patient will be divided into three groups consists of group A (NS), group B (0.1% Ropivacaine), group C ( 0.2% ropivacaine) Then we will assess the patients for post craniotomy pain through NRS scale, patient satisfaction score. Outcome measures of this study will assess the post operative pain in patients undergoing elective craniotomy by NRS scale,patient satisfaction score, hemodynamic parameters such as HR, SBP, DBP, MAP,SPO2, RR, Preoperative and postoperative GCS. |