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CTRI Number  CTRI/2024/11/076271 [Registered on: 05/11/2024] Trial Registered Prospectively
Last Modified On: 10/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A comparison of isobaric versus hypobaric plus isobaric drugs in segmental thoracic spinal anaesthesia for reducing shoulder pain during laparoscopic cholecystectomy 
Scientific Title of Study   A randomized controlled trial comparing isobaric versus hypobaric plus isobaric drug in segmental thoracic spinal for reducing shoulder pain during laparoscopic cholecystectomy 
Trial Acronym  BARIC-LC 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Richa Chandra  
Designation  Professor 
Affiliation  RMCH BAREILLY 
Address  Department of Anaesthesiology, 4, Pilibhit Bypass Rd, Pawan Vihar, Bareilly, Uttar Pradesh 243006

Bareilly
UTTAR PRADESH
243006
India 
Phone  8279783945  
Fax    
Email  rinkichandra@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Anmol Singh 
Designation  Senior Resident (Academic, DM CTVA) 
Affiliation  IPGME&R SSKM Kolkata 
Address  Department of Cardiac, Thoracic and Vascular Anaesthesia, CTVA CTVS building, IPGMER SSKM Hospital, 244, A.J.C. Bose Road, Kolkata 700 020

Kolkata
WEST BENGAL
700020
India 
Phone  7009061716  
Fax    
Email  dranmolsinghchd@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Anmol Singh 
Designation  Senior Resident (Academic DM CTVA) 
Affiliation  IPGME&R SSKM Kolkata 
Address  Department of Cardiac, Thoracic and Vascular Anaesthesia, CTVA CTVS building, IPGMER SSKM Hospital, 244, A.J.C. Bose Road, Kolkata 700 020

Kolkata
WEST BENGAL
700020
India 
Phone  7009061716  
Fax    
Email  dranmolsinghchd@gmail.com  
 
Source of Monetary or Material Support  
RMCH BAREILLY UTTAR PRADESH Bareilly 4, Pilibhit Bypass Rd, Pawan Vihar, Bareilly, Uttar Pradesh 243006 
Self 
 
Primary Sponsor  
Name  RMCH BAREILLY 
Address  RMCH BAREILLY UTTAR PRADESH Bareilly 4, Pilibhit Bypass Rd, Pawan Vihar, Bareilly, Uttar Pradesh 243006 
Type of Sponsor  Research institution and hospital 
 
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 Richa Chandra  RMCH BAREILLY  Office of Dr Professor Richa Chandra, Department of Anaesthesia, RMCH BAREILLY, 4, Pilibhit Bypass Rd, Pawan Vihar, Bareilly, Uttar Pradesh 243006
Bareilly
UTTAR PRADESH 
8279783945

rinkichandra@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, RMCH, Bareilly, UP  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 
Intervention  Thoracic Segmental Spinal injection  Thoracic spinal anesthesia at T9-T10 
Comparator Agent  Thoracic Segmental Spinal injection of Isobaric bupivacaine + Dexmedetomidine .  Thoracic spinal anesthesia at T9-T10 with 2.2 ml of isobaric bupivacaine 0.5% and 5 mcg Dexmedetomidine . 
Comparator Agent  Thoracic spinal anesthesia at T9-T10 with hypobaric bupivacaine 0.1%, followed by isobaric bupivacaine 0.5% and Dexmedetomidine  Thoracic spinal anesthesia at T9-T10 with 2 ml of hypobaric bupivacaine 0.1%, followed by 2 ml of isobaric bupivacaine 0.5% and 5 mcg Dexmedetomidine, administered after 45 seconds. Hypobaric bupivacaine 0.1% will be freshly prepared by mixing 1 ml of 0.5% bupivacaine to 4 ml of sterile distilled water.  
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  20 to 70 years, with ASA physical status I-II, scheduled for elective laparoscopic cholecystectomy 
 
ExclusionCriteria 
Details  ASA III-V, BMI more than 35, contraindications to regional anesthesia e.g., local infection, coagulopathy, allergy to study drugs, and spinal abnormalities e.g. kyphosis, scoliosis. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Primary Outcome: Shoulder pain assessed using a visual analog scale (VAS) during surgery, at the end of surgery, and at 2, 6, 12, and 24 hours postoperatively.
 
T1 : Intraop
T2 : 2hrs Post Op
T6 : 6 Hrs Post Op
T12 : 12 Hrs Post Op
T24 : 24 Hrs Post Op 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary Outcomes:
Total intraoperative and postoperative analgesic use.
Time to first analgesic request.
Incidence of adverse effects (hypotension, bradycardia, nausea, vomiting).
Patient satisfaction score at 24 hours post-surgery. 
T1 : Intraop
Ta : Time to first analgesic request
T24 : 24 Hrs Post Op 
 
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)   16/11/2024 
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="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. 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).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rinkichandra@yahoo.com].

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2027?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary  

Preoperative Preparation

Written informed consent will be obtained from all participants. Preoperative evaluation will include a complete clinical examination, CBC, renal function tests, liver function tests, ECG, and, where indicated, chest X-ray and echocardiography. Anxiety levels will be assessed using a validated scale to ensure comparability among groups.

Anesthesia Procedure

Anesthesia will be provided by a senior consultant proficient in segmental thoracic spinal anesthesia. Patients will be positioned sitting for the spinal block, and standard monitoring (ECG, NIBP, SpO2) will be initiated. Under aseptic precautions, subarachnoid block will be performed using a 27G Quincke Babcock needle. For thoracic spinal anesthesia, the T9-T10 space will be identified using anatomical landmarks (C7 spine, T7 scapular level, L1 corresponding to the 12th rib).

Following the block, patients will be immediately placed in the supine position, and oxygen will be administered at 4-6 L/min via a mask. Vital signs will be recorded every minute for the first 15 minutes, then every 5 minutes until the completion of surgerySensory levels will be assessed with a pinprick test, aiming for coverage from of required dermatome. Motor blockade will be assessed using the Bromage scale. Hypotension (SBP <90 mmHg) will be treated with intravenous mephentermine (6 mg), and bradycardia (HR <50/min) with atropine (0.6 mg). Sedation will be achieved with intravenous midazolam (1 mg) and fentanyl (1-1.5 mcg/kg). Postoperative shoulder pain will be treated with tramadol (50 mg) if needed, and intraoperative nausea and vomiting with ondansetron (4 mg).

Statistical Analysis

Data will be collected using standardized forms. Data will be analyzed using SPSS version 25. Continuous variables (e.g., pain scores, hemodynamic parameters) will be expressed as means ± standard deviation and analyzed using paired t-test or Mann Whitny U-test depending on the distribution of data. Categorical variables (e.g., incidence of shoulder pain) will be compared using Chi-square or Fisher’s exact test. A p-value of < 0.05 will be considered statistically significant. Logistic regression will be performed to control for potential confounding variables.

 
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