| CTRI Number |
CTRI/2024/02/062847 [Registered on: 19/02/2024] Trial Registered Prospectively |
| Last Modified On: |
16/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to comparatively evaluate the analgesic efficacy of ultrasound guided erector spinae plane block versus wound site infiltration in patients undergoing open nephrectomy. |
|
Scientific Title of Study
|
Ultrasound guided erector spinae plane block versus wound site infiltration for postoperative analgesia in patients undergoing open nephrectomy |
| 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 Udeyana Singh |
| Designation |
Associate Professor Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India Ludhiana PUNJAB 141001 India
Ludhiana
PUNJAB 141001 India Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India Ludhiana PUNJAB 141001 India
Ludhiana
PUNJAB 141001 India Ludhiana PUNJAB 141001 India |
| Phone |
8968580004 |
| Fax |
|
| Email |
udeyana@yahoo.co.in |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Inayat Jearth |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India Ludhiana PUNJAB 141001 India
Ludhiana
PUNJAB 141001 India Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India Ludhiana PUNJAB 141001 India
Ludhiana
PUNJAB 141001 India Ludhiana PUNJAB 141001 India |
| Phone |
9815855260 |
| Fax |
|
| Email |
inayat.jearth80@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Inayat Jearth |
| Designation |
PG Resident Anaesthesia |
| Affiliation |
Dayanand Medical College and Hospital |
| Address |
Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India Ludhiana PUNJAB 141001 India
Ludhiana
PUNJAB 141001 India Department of Anaesthesia Dayanand Medical College and Hospital Civil Lines Ludhiana 141001 Punjab India Ludhiana PUNJAB 141001 India
Ludhiana
PUNJAB 141001 India Ludhiana PUNJAB 141001 India |
| Phone |
9815855260 |
| Fax |
|
| Email |
inayat.jearth80@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Medical college and hospital,Tagore Nagar,Civil lines,Ludhiana.141001 Punjab India |
|
|
Primary Sponsor
|
| Name |
Dayanand Medical college and Hospital |
| Address |
Tagore Nagar, Civil lines, Ludhiana. 141001 Punjab India |
| 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 Udeyana Singh |
Dayanand Medical College and Hospital ludhiana |
Department of Anaesthesia , first floor Ludhiana PUNJAB |
8968580004
udeyana@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical committee,Dayanand medical college and hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N19||Unspecified kidney failure, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Ultrasound guided erector apinae plane block |
Patients in group A will recieve 30ml of 0.2% ropivacaine after induction of general anaesthesia. |
| Comparator Agent |
Wound site infiltration |
Patients in group B will receive subcutaneous infiltration of 30ml of 0.2% ropivacaine along the line of incision at the end of surgery. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Adult patients of 18-75 years of age, American Society of Anaesthesiologists (ASA) I-III undergoing open nephrectomy with flank incision |
|
| ExclusionCriteria |
| Details |
1. Patients allergic to local anaesthetics being used
2. Infection at the site of infiltration of local anaesthetic
3. Patients with uncontrolled bleeding diathesis evidenced by history and laboratory investigations
4. Patients with Psychiatric disorder
5. Patients unable to comprehend VAS score
6. Patients with chronic opioid abuse
7. Refusal to participate in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the analgesic efficacy of ESPB and wound site infiltration in open nephrectomy patients in post operative period. |
Comparative consumption of the total amount of rescue opioid analgesic in a 24 hour period among both the groups will be noted and bidirectional Visual Analogue Scale(VAS) will be recorded at rest and on movement preoperatively i.e prior to block administration before induction of general anesthesia and then postoperatively every hourly for the first 4 hours, 2 hourly for next 2 hours and 4 hourly till 24 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Duration of analgesia and Quality of revovery questionnare |
Quality of recovery questionnare at 24 hours postoperatively |
|
|
Target Sample Size
|
Total Sample Size="44" Sample Size from India="44"
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 2 |
|
Date of First Enrollment (India)
|
29/02/2024 |
| 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="6" Days="29" |
|
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
|
Acute pain management in open nephrectomy is a challenging issue, due to large subcostal flank incision that is generally employed to have a wide operative field but, it requires considerable amount of muscle cutting giving rise to somatic pain transmitted through intercostal nerves at T9-T11. In addition, visceral pain is also a component of postoperative pain which is transmitted through sympathetic fibers T8-T12 spinal segments. There are limited studies on erector spinae plane block being used for pain relief in patients undergoing open nephrectomy, hence we propose to study the analgesic efficacy of erector spinae plane block vs wound site infiltration in open nephrectomy surgeries. A randomized observational study will be conducted in ASA I-III patients, aged 18-75 years, of either sex, undergoing open nephrectomy with flank incision under general anesthesia with endotracheal intubation.These patients will be randomly allocated into 2 groups, one group will receive ultrasound guided erector spinae plane block with 30 ml of 0.2% ropivacaine after the induction of general anesthesia and second group will receive local infiltration of 30 ml of 0.2% ropivacaine (LIA) along the line of skin incision at the end of surgery. Duration of pain relief and Visual Analogue scale (VAS) scores for pain will be recorded as primary outcome measures, with quality of recovery score (QoR-15) and cumulative amount of rescue analgesia needed, as secondary outcome variables. |