| CTRI Number |
CTRI/2024/04/065589 [Registered on: 12/04/2024] Trial Registered Prospectively |
| Last Modified On: |
10/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare specific nerve injection with local site injection in kidney stone surgeries for post operation pain relief. |
|
Scientific Title of Study
|
COMPARISON OF UNILATERAL ERECTOR SPINAE PLANE
BLOCK AND LOCAL INFILTRATION OF THE
INCISION SITE FOR POSTOPERATIVE ANALGESIA IN
PERCUTANEOUS NEPHROLITHOTOMY – A RANDOMISED
COMPARATIVE 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 Neha Gupta |
| Designation |
Assistant professor |
| Affiliation |
Dr. B. R. Ambedkar Medical College and Hospital |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, DR. B R AMBEDKAR
MEDICAL COLLEGE AND HOSPITAL, K G HALLI
Bangalore KARNATAKA 560045 India |
| Phone |
8928351213 |
| Fax |
|
| Email |
drng2105@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Neha Gupta |
| Designation |
Assistant professor |
| Affiliation |
Dr. B. R. Ambedkar Medical College and Hospital |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, DR. B R AMBEDKAR
MEDICAL COLLEGE AND HOSPITAL, K G HALLI
Bangalore KARNATAKA 560045 India |
| Phone |
8928351213 |
| Fax |
|
| Email |
drng2105@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Bhavyashree V |
| Designation |
Post graduate |
| Affiliation |
Dr. B. R. Ambedkar Medical College and Hospital |
| Address |
DEPARTMENT OF ANAESTHESIOLOGY, DR. B R AMBEDKAR
MEDICAL COLLEGE AND HOSPITAL, K G HALLI
Bangalore KARNATAKA 560045 India |
| Phone |
08867777336 |
| Fax |
|
| Email |
venugopal1364@gmail.com |
|
|
Source of Monetary or Material Support
|
| DR. B R AMBEDKAR MEDICAL COLLEGE AND HOSPITAL, BENGALURU |
|
|
Primary Sponsor
|
| Name |
Dr Neha gupta |
| Address |
DEPATMENT OF ANESTHESIOLOGY, DR. B R AMBEDKAR
MEDICAL COLLEGE AND HOSPITAL, BENGALURU |
| 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 Neha gupta |
Dr. B. R. Ambedkar Medical College and Hospital |
1st FLOOR, OT COMPLEX,
DEPARTMENT OF ANESTHESIA,
DR B R AMBEDKAR
MEDICAL COLLEGE, K
G HALLI, BENGALURU
- 560045
Bangalore KARNATAKA |
8928351213
drng2105@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution Ethics Committee Dr. B. R. Ambedkar Medical College and Hospital |
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 |
USG guided Erector Spinae Plane Block with 20 mL of 0.25% Bupivacaine + Inj. Dexamethasone 8mg
Given once
Preoperatively
From the time of block to 24 hours after surgery |
| Comparator Agent |
Local anesthetic infiltration
|
Local anesthetic infiltration of incision site with 20 mL of 0.25% bupivacaine + Inj. Dexamethasone 8mg
Given once
Preoperatively
From the time of block to 24 hours after surgery |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients posted for Percutaneous Nephrolithotomy Surgeries.
2. Age ≥ 18 years.
3. American Society of Anaesthesiologists (ASA) class I and II patients. |
|
| ExclusionCriteria |
| Details |
1.Patients with history of known allergy to local anesthetic agent
2. Patients who have contraindications to peripheral nerve blocks
3. Infection at the site of injection
4. Body mass index more than 35 kg/m2
5. Drug abuse, sepsis, bacteremia physiological or other emotional problems. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess the duration of postoperative analgesia of USG guided ESPB compared
with surgical site local infiltration in patients undergoing PCNL |
24 hours after surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To compare the total need of rescue analgesia in first 24 hours.
2. Incidence of postoperative nausea and vomiting |
24 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="34" Sample Size from India="34"
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)
|
01/05/2024 |
| 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="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
|
Percutaneous nephrolithotomy (PCNL) is a minimally invasive surgical technique and a gold standard technique for the removal of large (>20 mm) renal and upper ureteric calculi. However, it may be associated with substantial postoperative pain due to stretching of the renal capsule the parenchymal tract and from the incision of the skin, subcutaneous tissue, muscle layer, and the presence of nephrostomy tube. Several modalities of analgesia have been tried to decrease post operative pain. The analgesic modalities that have been tried include: several systemic analgesics [opioids, non-steroidal anti-inflammatory drugs (NSAIDs)], paracetamol, and regional techniques (subcutaneous infiltration, peritubal infiltration, intercostal nerve block (ICNB), paravertebral block (PVB), epidural analgesia] that have been tried for providing postoperative analgesia. While NSAIDs can have potential systemic side effects in these patients with possible kidney injury, other regional techniques like epidural and paravertebral blocks can be pretty invasive. Patients posted for PCNL surgery often have suboptimal renal function and non-steroidal anti-inflammatory drugs (NSAID) are potentially nephrotoxic. Therefore novel regional anesthetic techniques that would provide optimal pain control without significant adverse effects need to be explored. Erector Spinae Plane Block (ESPB) is a novel analgesic technique which was first described in 2016 for thoracic neuropathic pain. It has subsequently found efficacious for acute pain control after surgeries like Mastectomies, Percutaneous Nephrolithotomy, Lumbar spine surgeries, Laparoscopic Cholecystectomy. ESPB involves injection of the local anaesthetic into the plane between the erector spinae muscle sheath and the transverse process of the vertebra. When injected, the injectate spreads cranio-caudally resulting in the blockage of multiple vertebral levels. ESPB affects both the ventral and dorsal rami, leading to blockage of both visceral and somatic pain. Local anesthetic infiltration of incision site is another novel modality of pain relief in PCNL surgery (skin, subcutaneous tissue, renal capsule, and parenchymal tract) is done with local anesthetic drugs. This can produce significant reduction of pain as assessed by visual analog scale (VAS) score with less demand for rescue analgesia. This study was designed to compare the efficacy of USG guided ESPB with local infiltration at the incision site in providing postoperative analgesia following PCNL. |