| CTRI Number |
CTRI/2024/12/077711 [Registered on: 05/12/2024] Trial Registered Prospectively |
| Last Modified On: |
04/12/2024 |
| Post Graduate Thesis |
|
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the effects of two drugs, Adenosine and Magnesium Sulphate for control of pain after Gall bladder surgery |
|
Scientific Title of Study
|
Adenosine vs Magnesium Sulphate as Adjuvants in Erector Spinae Plane block for post operative analgesia in patients undergoing Laproscopic Cholecystectomy : A Randomized Clinical 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 Neha Chajgotra |
| Designation |
Senior Resident Department of Anaesthesiology |
| Affiliation |
Government medical college Kathua |
| Address |
Department of Anaesthesiology and critical care GMC Kathua, Kathua , Jammu and Kashmir
Jammu
JAMMU & KASHMIR
184101
India |
| Phone |
7006903323 |
| Fax |
|
| Email |
Chajgotraneha55@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajesh Angral |
| Designation |
Associate Professor Department of Anaesthesiology |
| Affiliation |
Government medical college Kathua |
| Address |
Department of Anaesthesiology and critical care, GMC Kathua, Kathua , Jammu and kashmir
Jammu
JAMMU & KASHMIR
184101
India |
| Phone |
7006047500 |
| Fax |
|
| Email |
rajeshangral73@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajesh Angral |
| Designation |
Associate Professor Department of Anaesthesiology |
| Affiliation |
Government medical college Kathua |
| Address |
Department of Anaesthesiology and critical care, GMC Kathua, Kathua, Jammu and kashmir
JAMMU & KASHMIR
184101
India |
| Phone |
7006047500 |
| Fax |
|
| Email |
rajeshangral73@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government medical college Kathua , District Kathua, Jammu and Kashmir, India pin 184101 |
|
|
Primary Sponsor
|
| Name |
Dr Neha Chajgotra |
| Address |
HNO 1 sector 2 Sanjay Nagar Jammu , Jammu and Kashmir, India pin 180010 |
| 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 |
| Dr Rajesh Angral |
Hospital , Government Medical College Kathua |
Department of Anaesthesiology and critical care, GMC Kathua ,district Kathua, Jammu and Kashmir , India, pin 184102
Kathua
JAMMU & KASHMIR |
7006047500
rajeshangral73@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Govt. Medical College Kathua |
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 |
Erector Spinae block ESP block |
USG guided ESP block for postoperative analgesia for 24 hours following laparoscopic cholecystectomy . In both the groups, the pre-emptive single shot ultrasound guided ESP block will be performed on both sides in the interfacial plane between the erector Spinae muscle and the transverse process . |
| Comparator Agent |
ESP block |
Adenosine vs magnesium sulphate as adjuvants in ESP block for postoperative analgesia following laparoscopic cholecystectomy .
Adenosine 12 mg added as an adjuvant with local anaesthetic 20 mL of Ropivacaine hydrochloride 0.25% + 1 mL saline 0.9% and another comparative adjuvant magnesium sulphate 500mg added with 20 ml of local anaesthetic Ropivacaine hydrochloride 0.25% + 4 ml of saline. 25 ml of total drug given on each side and administered as paraspinal fascia plane block in which the needle placement is between the erector Spinae muscle and the thoracic transverse processes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients between age group of 18 to 60 years who are undergoing laparoscopic cholecystectomy
ASA class 1 and 2
Patients who are willing to participate and provide a willing written informed consent |
|
| ExclusionCriteria |
| Details |
Patients with any chronic medical illness
Patients allergic to any of these drugs
History of any bleeding disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Severity of pain using visual analog score
Time to 1st rescue analgesia |
VAS Score will be recorded at 1,2,6,12 and 24 hours after the surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Total number of analgesic doses of opioids and NSAIDS in 24 hours following surgery
Side effects like nausea, vomiting and shivering |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/12/2024 |
| 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="6"
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
|
This study is a randomized, parallel group, clinical trial comparing the effectiveness and safety of adenosine and magnesium sulphate as adjuvants in errector Spinae plane block for postoperative analgesia in patients undergoing laparoscopic cholecystectomy, as measured by duration of analgesia and pain score. The primary outcome of the study is to record the time of 1st rescue analgesia I.e the time elapsed between the end of surgery to 1st analgesia dose and severity of pain using VAS. The secondary outcome is total no. of analgesic doses of opioids and NSAIDS in 24 hours following surgery and side effects like nausea, vomiting and shivering. |