| 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
|
|
|
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
|
|
|
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
- 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
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- 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 [rinkichandra@yahoo.com].
- 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.
- 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 surgery. Sensory 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. |