| CTRI Number |
CTRI/2023/07/055370 [Registered on: 19/07/2023] Trial Registered Prospectively |
| Last Modified On: |
17/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessment Of The Effects On Pain Free Period And Requirement Of Pain-Killer After Endoscopic Removal Of Kidney Using Either Ultrasound Guided Nerve Block In A Muscle Of Back ( Erector Spinae) Or An Epidural Block (A Space Of Spinal Region) |
|
Scientific Title of Study
|
Comparison Of Ultrasound Guided Continuous Erector Spinae Plane Block And Epidural Block For Postoperative Analgesia In Laparoscopic Nephrectomy : A Prospective Randomized 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 Amita Singh |
| Designation |
Junior Resident M.D. Anaesthesiology |
| Affiliation |
King Georges Medical University |
| Address |
Department Of Anaesthesiology, King Georges Medical University
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9897265092 |
| Fax |
|
| Email |
amita.lsg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinod Kumar Srivastava |
| Designation |
Assistant Professor, M.D. Anaesthesiology |
| Affiliation |
King Georges Medical University |
| Address |
Department Of Anaesthesiology, King Georges Medical University
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9415795565 |
| Fax |
|
| Email |
vinod123.doctor@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amita Singh |
| Designation |
Junior Resident M.D. Anaesthesiology |
| Affiliation |
King Georges Medical University |
| Address |
Department Of Anaesthesiology, King Georges Medical University
Lucknow
UTTAR PRADESH
226003
India |
| Phone |
9897265092 |
| Fax |
|
| Email |
amita.lsg@gmail.com |
|
|
Source of Monetary or Material Support
|
| King Georges Medical University, Lucknow, Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr Amita Singh |
| Address |
Department Of Anaesthesiology, KGMU, Lucknow |
| 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 Vinod Kumar Srivastava |
King Georges Medical University |
Department Of Anaesthesiology, King Georges Medical University, Lucknow
UTTAR PRADESH
Lucknow
UTTAR PRADESH |
9415795565
vinod123.doctor@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, King Georges Medical University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N258||Other disorders resulting from impaired renal tubular function, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Epidural Block Using Landmark Technique Is The Conventional Method For Perioperative Analgesia In Laparoscopic Nephrectomy |
Frequency: For 24 Hours Post Operatively
Device Duration: For 24 Hours Post Operatively
Route: Epidural Block Dose 0.25% Levobupivacaine 10 Ml With Fentanyl 2 Mcg/Ml Followed By Continuous Infusion Of 0.25% Levobupivacaine And Fentanyl 2 Mcg/Ml At A Rate Of 6 Ml/Hr For 24 Hours Postoperatively |
| Comparator Agent |
Ultrasound Guided Continuous Erector Spinae Plane Block For Perioperative Analgesia In Laparoscopic Nephrectomy |
Frequency: For 24 Hours Post Operatively
Device Duration: For 24 Hours Post Operatively
Route: Intramuscular Dose 0.25% Levobupivacaine 20 Ml With Fentanyl 2 Mcg/Ml Bolus Followed By Continuous Infusion Of 0.25% Levobupivacaine And Fentanyl 2 Mcg/Ml At A Rate Of 6 Ml/Hr For 24 Hours Postoperatively |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA Physical Status I and II.
Aged Between 18 To 65 Years.
Patient Scheduled To Undergo Elective Laparoscopic Nephrectomy Under General Anaesthesia. |
|
| ExclusionCriteria |
| Details |
Negative Consent/Refusal.
Local Infection.
Coagulopathies.
Cardiovascular Disease, Respiratory Disease And Gastrointestinal Disorders.
Psychiatric And Cognitive Disorders.
Allergic To Study Drug Used.
Spinal Dysraphism/Deformity.
Chronic Opioid/Analgesic User. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Time Of Use Of First Dose Of Rescue Analgesia (Injection Tramadol 100 Mg Iv) Measured From Time Of Giving Block/Epidural. |
Time Of Use Of First Dose Of Rescue Analgesia Within 24 Hours Period |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Cumulative dose of analgesics consumed in first 24 hours
after surgery.
2. Post-operative VAS in first 24 hours at
3. Perioperative hemodynamic (heart rate, mean blood
pressure, respiratory rate, SpO2) changes at
4. Total intraoperative fentanyl consumption if heart rate
or blood pressure or both increase 20% of baseline
5. Procedure related complications.
6. Bowel recovery & ambulation |
0,30 mins,1,2,4,6,12,24 hrs) Within 24 Hours Post operatively |
|
|
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)
|
25/07/2023 |
| 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
|
To Determine Which Of The Following Two Blocks: Ultrasound Guided Continous Erector Spinae Block And Epidural Block Is Superior For Postoperative Analgesia In Laparoscopic Nephrectomy. Nepherectomy Is A Surgical Procedure Done To Remove Either A Diseased Or Healthy Kidney Via Open Or Laparoscopic Approaches. Acute Pain After Nephrectomy Remains A Major Problem. Chronic Pain Develops in 20 To 26 % Of Patients Undergoing Nephrectomy Leading To Higher Opiod Consumption With Many Adverse Effects.The Paravertebral Block And Epidural Block Are Common Blocks Used In Different Thoracic And Abdominal Surgeries With Some Complications.Studies Have Found That ESPB Affects Both The Ventral And Dorsal Rami, Leading To Blockage Of Both VIsceral And Somatic Pain. Because ESPB Is An Easy And Safe Method To Use, We Believe That It Is An Essential Part Of Anaesthesia Management For Nephrectomy. Thus We Have Planned A Comparative Study Of Continous ESPB Using A Catheter And Continous Epidural Block For Postoperative Analgesia In Laparoscopic Nephrectomy. |