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CTRI Number  CTRI/2025/12/099630 [Registered on: 22/12/2025] Trial Registered Prospectively
Last Modified On: 20/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   “Ropivacaine Instillation Through Subgaleal Drain: An Effective Approach to Post-Craniotomy Pain Relief” 
Scientific Title of Study   A Study of efficacy of Ropivacaine Instillation Through Subgaleal Drain for Post Craniotomy Pain Management A Randomized Controlled 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  Dr AKHIL A G 
Designation  junior resident 
Affiliation  Shri B M patil medical college hospital and research centre 
Address  Department of anesthesiology 3rd floor shri B M Patil medical college hospital and research centre vijayapura, Karnataka India Bijapur KARNATAKA 586103 India

Bijapur
KARNATAKA
586103
India 
Phone  9743973202  
Fax    
Email  akhil47silver@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr SRIDEVI M MULIMANI 
Designation  Professor dept of anesthesiology 
Affiliation  Shri B M patil medical college hospital and research centre 
Address  Department of anesthesiology, 3rd floor shri B M Patil medical college hospital and research centre vijayapura Karnataka India Bijapur KARNATAKA 586103 India

Bijapur
KARNATAKA
586103
India 
Phone  9449534216  
Fax    
Email  sridevi.mulimani@bldedu.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr SRIDEVI M MULIMANI 
Designation  Professor dept of anesthesiology 
Affiliation  Shri B M patil medical college hospital and research centre 
Address  Department of anesthesiology, 3rd floor shri B M Patil medical college hospital and research centre vijayapura Karnataka India Bijapur KARNATAKA 586103 India

Bijapur
KARNATAKA
586103
India 
Phone  9449534216  
Fax    
Email  sridevi.mulimani@bldedu.ac.in  
 
Source of Monetary or Material Support  
Self 
 
Primary Sponsor  
Name  Dr AKHIL A G 
Address  Department of anesthesiology, 3rd floor shri B M Patil medical college hospital and research centre vijayapura Karnataka India Bijapur KARNATAKA 586103 India Bijapur KARNATAKA 586103 India  
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
Nil   Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Akhil AG  Department of anesthesiology , shri B M Patil medical college   Department of anesthesiology 3rd floor shri B M Patil medical college hospital and research centre vijayapura, Karnataka India Bijapur
Bijapur
KARNATAKA 		 9743973202

akhil47silver@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BLDE ethical committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Group P Inj pct given as post op analgesia  The group P will receive 15ml/kg of IV Inj Paracetamol 6th hourly. Following drug administration, Postoperative pain will be measured using the Visual Analog Scale (VAS) at 1, 4, 8, 10, 12, and 24 hours post-surgery. If a patients VAS score exceeds 4 at any time, rescue analgesia will be provided using either intravenous Diclofenac (75 mg) or intravenous Paracetamol (1 g). Additionally, sedation levels will be evaluated using the Richmond Agitation-Sedation Scale (RASS) and recovery status assessed using the Modified Aldrete Score (MAS). Post operative nausea and vomiting or any other adverse events or complications will be documented and addressed accordingly. Blood in the drain will also be documented 
Intervention  instillation of inj ropivacaine through subgaleal drain for post craniotomy pain management  All patients included in the study will undergo a standard preoperative assessment and will be kept nil per oral (NPO) for at least 8 hours prior to surgery. In the operating room, routine monitors will be attached including ECG, non-invasive blood pressure, pulse oximetry, and capnography. Following preoxygenation, patients will be induced with IV In j Fentanyl 2 µg/kg, IV Inj Propofol 2 mg/kg, and IV Inj Atracurium 0.5 mg/kg to facilitate endotracheal intubation. Using cuffed endotracheal tube airway will be secured. Anaesthesia will be maintained with Isoflurane at MAC value 0.8 -1.2 in a mixture of 50% Nitrous oxide with oxygen, along with intermittent doses of IV Inj Atracurium 0.1mg/kg as needed. All procedures will adhere to standard neurosurgical positioning protocols and strict aseptic techniques. A total of 46 patients will be enrolled and randomly assigned into two equal groups(23) (Group R and Group P) using a computer-generated randomization sequence. After completion of skin closure, the group R will receive 15 mL of 0.25% Ropivacaine, administered aseptically via the subgaleal drain. The group P will receive 15ml/kg of IV Inj Paracetamol 6th hourly. Following drug administration, skin dressing will be completed. Isoflurane and nitrous oxide will be discontinued, and patients will be ventilated with 100% oxygen. Once spontaneous breathing resumes, reversal of neuromuscular blockade will be achieved with intravenous Neostigmine (0.05 mg/kg) and Glycopyrrolate (0.01 mg/kg). Upon full awakening, the endotracheal tube will be removed, oral suction will be performed, and patients will be transferred to the neurosurgical intensive care unit (ICU) for monitoring. Postoperative pain will be measured using the Visual Analog Scale (VAS) at 1, 4, 8, 10, 12, and 24 hours post-surgery. If a patients VAS score exceeds 4 at any time, rescue analgesia will be provided using either intravenous Diclofenac (75 mg) or intravenous Paracetamol (1 g). Additionally, sedation levels will be evaluated using the Richmond Agitation-Sedation Scale (RASS) and recovery status assessed using the Modified Aldrete Score (MAS). Post operative nausea and vomiting or any other adverse events or complications will be documented and addressed accordingly. Blood in the drain will also be documented 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Adults aged 18 to 70 years
Patients undergoing supratentorial craniotomy
ASA physical status I to III 
 
ExclusionCriteria 
Details  Gcs less than 12
Allergic to local anesthetic
Previous history of brain surgery 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess postoperative pain scores using the Visual Analog Scale (VAS) at
predefined time intervals (1,4,8,10,12, 24 hours)
o To evaluate the time to first rescue analgesia postoperatively 		 time intervals 1,4,8,10,12, 24 hour 
 
Secondary Outcome  
Outcome  TimePoints 
To assess total number of analgesics consumption within the first 24 hours
postoperatively
o To assess Richmond Agitation Sedation Score (RASS) and Modified Aldrete score
(MAS) at the intervals of (1,4,8,10,12,24 hours 		 Time interval 1,4,8,10,12,24hours 
 
Target Sample Size   Total Sample Size="46"
Sample Size from India="46" 
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)   01/01/2026 
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)   Open to Recruitment 
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  

Post-craniotomy pain is frequently underestimated, yet evidence shows that most patients experience moderate to severe pain in the first 24 hours after surgery. Effective analgesia is essential, but the use of opioids and sedatives is limited because they can interfere with the neurological assessments required after brain surgery. Therefore, a safe, localized method of pain relief is needed.


This randomized controlled trial aims to evaluate the analgesic efficacy of instilling 15 mL of 0.25% Ropivacaine through the subgaleal drain—a space already created during craniotomy. This technique targets the innervated scalp tissues directly, offering localized analgesia with minimal systemic effects.


A total of 46 adult patients, undergoing elective supratentorial craniotomy, will be randomly assigned into two groups:


  • Group R: Subgaleal instillation of Ropivacaine
  • Group P: Standard IV Paracetamol 15 mg/kg every 6 hours



Postoperative monitoring will include VAS pain scores, time to first rescue analgesia, total analgesic use, sedation scores (RASS), recovery scores (Modified Aldrete), and adverse events such as nausea/vomiting. Rescue analgesia will be provided when VAS > 4.


The study aims to determine whether ropivacaine instillation provides better pain relief, prolongs time to rescue analgesia, reduces overall analgesic consumption, and enhances postoperative recovery, without affecting neurological evaluation.


 
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