| CTRI Number |
CTRI/2024/06/068995 [Registered on: 18/06/2024] Trial Registered Prospectively |
| Last Modified On: |
15/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Process of Care Changes
Other (Specify) [Assessing the quality of recovery in patients undergoing Cholecystectomy] |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of a local block/injection on the quality of recovery after operation, using a questioner in laparoscopic Cholecystectomy surgeries |
|
Scientific Title of Study
|
Effect of Erector spinae plane block on the Postoperative quality of recovery, using QoR-40 scale after laparoscopic Cholecystectomy- A randomized controlled clinical study |
| 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 Shobha Ujwal |
| Designation |
Senior Professor |
| Affiliation |
DR. SN MEDICAL COLLEGE |
| Address |
Department of Anesthesiology,
DR. SN Medical college,
Sector D, Shastri Nagar, Jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
9461028789 |
| Fax |
|
| Email |
drshobhaujwal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR CHETAN CHAUHAN |
| Designation |
PG Student |
| Affiliation |
Dr.SN Medical college |
| Address |
Department of Anesthesiology,
DR. SN Medical college,
Sector D, Shastri Nagar, Jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
8794760267 |
| Fax |
|
| Email |
chetanchauhan28@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chetan Chauhan |
| Designation |
Post Graduation Student |
| Affiliation |
DR. SN MEDICAL COLLEGE |
| Address |
Department of Anesthesiology,
DR. SN Medical college,
Sector D, Shastri Nagar, Jodhpur
Jodhpur
RAJASTHAN
342003
India |
| Phone |
8794760267 |
| Fax |
|
| Email |
chetanchauhan28@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology,
DR. SN Medical college,
Sector D, Shastri Nagar, Jodhpur, Rajasthan, India
342003 |
|
|
Primary Sponsor
|
| Name |
DR DN MEDICAL COLLEGE |
| Address |
Department of Anesthesiology
Dr. SN Medical college
Sector D, Shashtri Nagar, Jodhpur, Rajasthan
342003 |
| Type of Sponsor |
Government medical college |
|
|
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 Chetan Chauhan |
Mathura Das Mathur Hospital and Mahatma Gandhi Hospital, Jodhpur |
Department of Anesthesiology,
DR. SN Medical college and attached Hospitals,
Sector D, Shastri Nagar, Jodhpur, Rajasthan, India 342003
Jodhpur
RAJASTHAN |
8794760267
chetanchauhan28@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee DR SN medical College, Jodhpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Between one, receiving ESP Block under USG and other control group, not receiving any ESP Block. |
I am comparing in patients undergoing elective laparoscopic cholecystectomy, in which one group receives erector spinae plane block using inj Levobupivacaine 0.25% 20 ml on both side at T8 level under ultrasound guidance, and another control group does not receive any ESP block. Block will be given right after intubation and counted as zero. Observation will be done intra operative and 24 hours post operatively. |
| Intervention |
ESP Block under USG in Study group |
I am comparing between two groups undergoing elective laparoscopic cholecystectomy, in which one group receives erector spinae plane block using inj Levobupivacaine 0.25% 20 ml on both side under ultrasound guidance, and another control group does not receive any ESP block.
Block will be given right after intubation and counted as zero. Observation will be done intra operative and 24 hours post operatively. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients of ASA grade 1 and 2 posted for elective laparoscopic cholecystectomy of duration less than 90 minutes. |
|
| ExclusionCriteria |
| Details |
patients refusal to participate, known case of allergic to the study drug, having pre-existing wound at the site of injection, a case of chronic pain syndrome, on prolonged opioid therapy, coagulopathy, patient with history of previous abdominal surgeries, and surgery exceeding more than 90 minutes. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to compare quality of recovery between group receiving Erector spinae plane block and control group during first 24 hours after Laparoscopic Cholecystectomy. |
to compare quality of recovery between group receiving Erector spinae plane block and control group during first 24 hours after Laparoscopic Cholecystectomy. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| comparing between two groups The duration of Analgesia Cumulative dose of rescue analgesia & intra operative hemodynamic parameters. |
Duration of analgesia is when the patient requires Painkiller & intra operative parameters are recorded at a defined interval. Outcome assessment will be started at Baseline & 5 min 10min 15min 20min 30min 40min 60min & 90min.
patient will be observed up to 24 hours post operatively for quality of recovery. |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
26/06/2024 |
| 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 Yet Recruiting |
| 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
|
Laparoscopic abdominal surgeries are painful, even if they are minimal invasive, causing delayed recovery, increase opioid analgesic demand, increased hospital stay and cost. Hense giving pre-operative Erector Spinae Plane Block after intubation of patient under general anesthesia, patient can have stable intra operative hemodynamic parameters, good post operative pain relief and increase quality of recovery with less opioid analgesic need, early mobilization and reduced hospital stay and cost. |