CTRI Number |
CTRI/2020/09/027996 [Registered on: 23/09/2020] Trial Registered Prospectively |
Last Modified On: |
17/02/2022 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Surgical/Anesthesia |
Study Design |
Randomized, Parallel Group, Active Controlled Trial |
Public Title of Study
|
Post operative image guided pain relief with local anaesthesia in patients undergoing open nephrectomy |
Scientific Title of Study
|
Ultrasound guided Erector Spinae Plane Block for post operative analgesia in patients undergoing open nephrectomy |
Trial Acronym |
|
Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
Name |
Dr Deepak Oberoi |
Designation |
Associate Professor |
Affiliation |
Himalayan Institute of Medical Sciences |
Address |
Department of Anaesthesia
Himalayan Institute of Medical Sciences
Swami Rama Himalayan University
Dehradun
Uttaranchal
Dehradun UTTARANCHAL 248140 India |
Phone |
9876251926 |
Fax |
|
Email |
drdeepakoberoi@gmail.com |
|
Details of Contact Person Scientific Query
|
Name |
Dr Soumya Bindra |
Designation |
Postgraduate Resident |
Affiliation |
Himalayan Institute of Medical Sciences |
Address |
Department of Anaesthesia
Himalayan Institute of Medical Sciences
Swami Rama Himalayan University
Dehradun
Uttaranchal
Dehradun UTTARANCHAL 248140 India |
Phone |
9205208488 |
Fax |
|
Email |
soumya.bindra@gmail.com |
|
Details of Contact Person Public Query
Modification(s)
|
Name |
Dr Deepak Oberoi |
Designation |
Associate Professor |
Affiliation |
Himalayan Institute of Medical Sciences |
Address |
Department of Anaesthesia
Himalayan Institute of Medical Sciences
Swami Rama Himalayan University
Dehradun UTTARANCHAL 248140 India |
Phone |
9876251926 |
Fax |
|
Email |
drdeepakoberoi@gmail.com |
|
Source of Monetary or Material Support
|
Department of Anaesthesia
Himalayan Institute of Medical Sciences |
|
Primary Sponsor
|
Name |
Himalayan Institute of Medical Sciences |
Address |
Department of Anaesthesia
Himalayan Institute of Medical Sciences
Swami Rama Himalayan University
Dehradun
Uttaranchal |
Type of Sponsor |
Private 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 Rohan Bhatia |
Himlayan Institute of Medical Sciences |
Department of Anaesthesia
Himalayan Institute of Medical Sciences
Swami Rama Himalayan University
Jolly Grant
Dehradun
Uttaranchal Dehradun UTTARANCHAL |
9971014232
rohanbhatia@srhu.edu.in |
|
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: N288||Other specified disorders of kidney and ureter, |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Only general anaesthesia and PCA morphine in PACU |
Patients will receive only general anaesthesia during surgery. After being transferred to PACU patients will receive intravenous morphine by Patient Controlled Analgesia pump |
Intervention |
Ultrasound guided Erector Spinae Plane Block with general anaesthesia and PCA morphine in PACU |
Patients will be given general anaesthesia and after surgery, before reversal of anaesthesia, ultrasound guided Erector Spinae Plane Block will be given using linear transducer at T9 level with 0.5% Ropivacaine, 30 ml. After reversal of anaesthesia patients will be tranferred to PACU and intravenous morphine will be given by Patient Controlled Analgesia pump. |
|
Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
1. ASA physical status I and II
2. Age between 18 to 60 years.
3. Scheduled for open nephrectomy surgery. |
|
ExclusionCriteria |
Details |
1. Patient refusal for procedure.
2. Allergic to local anaesthetics.
3. Infection at local site.
4. Bleeding disorders.
5. Severe kidney dysfunction.
6. BMI above 30kg/m2.
7. Inabilty to give informed consent.
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
Method of Concealment
|
Alternation |
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
Primary Outcome
|
Outcome |
TimePoints |
To study the total opioid consumption over 24 hours after erector spinae block following open nephrectomy |
To study the total opioid consumption over 24 hours after erector spinae block following open nephrectomy |
|
Secondary Outcome
|
Outcome |
TimePoints |
To study the pain intensity using Numeric Rating Scle |
Pain intensity using a 10 point Numeric Rating Scale at 30 minutes, 2,4,6,8,12,18,24 hours respectively. |
To study the time of first analgesic used over 24 hours |
Time for first requested analgesic from time in PACU till discharge. |
To study any opioid related side effects |
Any side effects from opiods within the first 24 hours. |
To study patient satisfaction using a Likert- scale questionnaire |
Patient satisfaction about the overall pain management and quality of sleep at night on post operative day 0 using a Likert-scale with 0-6 score points |
|
Target Sample Size
|
Total Sample Size="48" Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "48"
Final Enrollment numbers achieved (India)="48" |
Phase of Trial
|
Post Marketing Surveillance |
Date of First Enrollment (India)
|
28/09/2020 |
Date of Study Completion (India) |
01/10/2021 |
Date of First Enrollment (Global) |
Date Missing |
Date of Study Completion (Global) |
01/10/2021 |
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
|
Post operative pain is a major concern after any surgery. Inadequate control of post operative pain is associated with a delay in recovery leading to an increase in incidence of chronic pain. An adequate post operative analgesia allows for early ambulation thereby reducing risks associated with long hospital stay and ultimately leading to enhanced recovery after surgery. While numerous methods exist for post operative pain management, a single modality of approach remains ineffective. Patients undergoing renal surgeries often have impaired renal functions and require judicious use of systemic analgesics. In the post operative period, patients undergoing nephrectomy are often managed with either opioids or epidural analgesia. In such scenarios, multimodal analgesia is a better choice since it is associated with reduced opioid requirement and its adverse effects. The ultrasound guided Erector Spinae Plane Block is a newer regional anaesthesia technique being currently explored as a viable option for analgesia. it is performed by injecting local anaesthetic in the plane between the rector spinae muscle and transverse process. The transverse process is easily identifiable and at a relative distance from any major vascular or neural structures. The local anaesthetic diffuses into paravertebral spaces between adjacent vertebrae and blocks both the dorsal and ventral branches of thoracic spinal nerves thus providing extensive analgesia with a single puncture. Keeping in mind a multimodal approach to postoperative pain and the ease of adminstration of the Erector Spinae Plane Block, this study is being planned with the view that ultrasound guided erector spinae plane black and intravenous patient contolled analgesia have an additive effect on postoperative pain management and would enable enhanced recovery after surgery and decrease post operative analgesic consumption in patients undergoing open nephrectomy. SAMPLE SIZE The
sample size was determined by using the NRS to compare the effectiveness by
assuming a difference of 1 in NRS between the two groups (group1 and group 2 ) as
clinically significant, thus sample size of 24 patients per group were
considered necessary to detect statistical significance with an effect size of
1.0 at alpha 0.05 and power of 90%
The formula for calculated sample size is
given below
n
= (σ12 + σ2 ) . (Z α + Zβ) 2
(M1 - M2) 2
=
(12 + 12).(1.96+1.64)2
(1) 2
= (1+1)*12.96
1
= 24
where
Zα/2 is the critical value of the Normal distribution at α/2 (e.g. for a
confidence level of 95%, α is 0.05 and the critical value is 1.96), Zβ is the
critical value of the Normal distribution at β (e.g. for a power of 90%, β is
0.1 and its critical value is 1.282) and σ 1 and σ 2 are the Standard
deviations of the two groups and M1 and M2 are the means of two groups. |