| CTRI Number |
CTRI/2024/05/067111 [Registered on: 09/05/2024] Trial Registered Prospectively |
| Last Modified On: |
08/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between 2 different mode and method of injection with local anaesthetic on quality of recovery after surgery. |
|
Scientific Title of Study
|
Effect of erector spinae plane block on quality of recovery in patients undergoing lumbar spine surgery. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Asaad Ahmad |
| Designation |
Post graduate student |
| Affiliation |
Maulana Azad Medical College. |
| Address |
Room no. 413, BL Taneja Block, 4th Floor, Department of Anaesthesiology, Maulana Azad Medical College.
Central
DELHI
110002
India |
| Phone |
8639231207 |
| Fax |
|
| Email |
asaadahmad9328@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sukhyanti Kerai |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College. |
| Address |
Room 413, BL Taneja Block, 4th floor, Department of Anaesthesiology, Maulana Azad Medical College.
Central
DELHI
110002
India |
| Phone |
9968527122 |
| Fax |
|
| Email |
drsukhi25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Asaad Ahmad |
| Designation |
Post graduate student |
| Affiliation |
Maulana Azad Medical College. |
| Address |
Room no.413, BL Taneja Block, 4th floor, Department of Anaesthesiology,Maulana Azad Medical College.
Central
DELHI
110002
India |
| Phone |
8639231207 |
| Fax |
|
| Email |
asaadahmad9328@gmail.com |
|
|
Source of Monetary or Material Support
|
| Lok Nayak Hospital, JLN Marg, near Delhi Gate, New Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Maulana Azad Medical College, 2 Bahadur Shah Zafar Marg, New Delhi-110002 |
| 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 Asaad Ahmad |
Lok Nayak Hospital |
OT-2, 2nd floor, New operation theatre block, Department of Anaesthesiology
Central
DELHI |
8639231207
asaadahmad9328@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 Plane Block |
Under USG guidance, ESP block will be given under all due aseptic precautions, after negative aspiration for blood, total 20ml of 0.25%bupivacaine with dexmedetomedine 0.5mcg/kg will be given slowly with intermittent negative aspiration on each side, single shot , facial plane block, before incision, with total procedure time of 10-15mins. |
| Comparator Agent |
Local anaesthetic infiltration |
Local anaesthetic infiltration with 0.25% 20ml of bupivacaine with dexmedetomidine 0.5mcg/kg at the proposed surgical site, single shot injection, with total duration of 5 mins. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anesthesiologist (ASA) physical status I,II & III
Expected surgical duration 2-4 hours.
|
|
| ExclusionCriteria |
| Details |
Surgical intervention for more than 2 vertebral levels.
Body Mass Index (BMI) 35kg/m2.
Pregnant patients.
Patients with known allergies to local anaesthestic drugs.
Patients with use of psychoactive substance.
Patients with chronic pain unrelated to surgical indication.
Contraindication to nerve block like coagulopathy and local site infections. |
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of Recovery-15 (QoR-15). |
24 hour after surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| QoR-15 score |
48 hours after surgery and at the time of discharge. |
| Numeric rating scale (NRS) scores (at rest and at movement) |
6,24,48 hours of surgery. |
| Mean time to first rescue analgesia |
After surgery. |
| Total analgesic consumption. |
At the end of 24 hours after surgery. |
| PONV impact scale score |
6,24,48 hours after surgery. |
| Mean time to passing of flatus |
After surgery. |
| Mean time ambulate with assistance. |
After surgery. |
| Post Operative Sleep Quality Index (PSQI). |
24,48 hours after surgery. |
|
|
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)
|
20/05/2024 |
| 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="1"
Months="0"
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
|
We are comparing the Quality of recovery with ultrasound guided Erector Spinae Plane Block with standard analgesia protocol and Local anaesthetic infiltration with standard analgesia protocol in patients 18-65 years of age undergoing lumbar spine surgery. The aim of study is to evaluate the effect of erector spinae plane block on quality of post operative recovery characteristics in patients undergoing lumbar spine surgery with a total sample size of 66 patients with 33 sample in each group. |