| CTRI Number |
CTRI/2020/12/029997 [Registered on: 23/12/2020] Trial Registered Prospectively |
| Last Modified On: |
19/12/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Role of erector spinae plane block for post operative pain after percutaneous nephrolithotomy. |
|
Scientific Title of Study
|
Efficacy of erector spinae plane block versus peritubal analgesic infiltration for post operative pain following percutaneous nephrolithotomy: A prospective randomized trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dinesh J Prajapati |
| Designation |
Consultant Anesthesiologist |
| Affiliation |
Muljibhai Patel Urological Hospital |
| Address |
Dr Virendra desai road,
Nadiad Near Sardar bridge, Kheda GUJARAT 387001 India |
| Phone |
02682520323 |
| Fax |
|
| Email |
dr_djp2011@hotmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dinesh J Prajapati |
| Designation |
Consultant Anesthesiologist |
| Affiliation |
Muljibhai Patel Urological Hospital |
| Address |
Dr Virendra Desai Road,
Near Sardar bridge Kheda GUJARAT 387001 India |
| Phone |
09879399866 |
| Fax |
|
| Email |
dr_djp2011@hotmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dinesh J Prajapati |
| Designation |
Consultant Anesthesiologist |
| Affiliation |
MULJIBHAI PATEL UROLOGICAL HOSPITAL |
| Address |
Dr Virendra Desai Road Near Saradar Bridge Kheda GUJARAT 387001 India |
| Phone |
09879399866 |
| Fax |
|
| Email |
dr_djp2011@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Muljibhai Patel Urological Hospital, Nadiad
|
|
|
Primary Sponsor
|
| Name |
Muljibhai Patel Urological Hospital Nadiad |
| Address |
Near Dr Virendra Desai Road, Nadiad-387001 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Shailesh Soni |
Muljibhai Patel Urological Hospital |
Department of Anesthesia Kheda GUJARAT |
02682520323
sonishail@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Muljibhai Patel Society for Research in Nephro-Urology Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N200||Calculus of kidney, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Group C |
Received standard anesthesia |
| Intervention |
Group E ( Erector spinae plan block) |
Received inj Rupivacaine 0.375% 20ml under USG guided ESP ( Erector spinae plan) Block |
| Intervention |
Group P ( Peritubal Infiltration) |
Received inj Rupivacaine 0.375% 20ml under fluoroscopy guided peritubal infiltration. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with American Society of Anesthesiologists (ASA) physical status classes I or II,
2.Aged 18–65 years
3.Scheduled for all unilateral PCNL, Mini PCNL and Tubeless PCNL under General anesthesia (GA)
|
|
| ExclusionCriteria |
| Details |
1.Psychological disorders,
2.Morbid obesity ( BMI>35), hepatic or renal dysfunction,
3.Coagulation disorders,
4.Sepsis, history of chronic analgesic use
5.History of allergy to local anesthetic agents
6.Restage PCNL
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the analgesia efficacy by visual analogue scale and need of rescue analgesia |
24 hours after procedure postoperatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the hemodynamic stability, duration of analgesia and total dosage of analgesia consumption |
24 hours after procedure postoperatively |
|
|
Target Sample Size
|
Total Sample Size="75" Sample Size from India="75"
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)
|
01/01/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL
|
|
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 commonly performed to treat the kidney stone. There are several effort has been done to minimise the postoperative pain such as multimodal analgesic regimens.[1-3] Ultrasound-guided erector spinae plane block (ESPB) is a novel interfascial paraspinal plane regional anesthesia technique, which was first used by Forero et al for the treatment of severe chronic thoracic neuropathic pain.[4]. Although the majority of ESPBs described were in the thoracic region and few studies available for the lumbar region for postoperative analgesia.[5] The studies reported that it was an effective technique for postoperative analgesia in patients having ventral hernia repair [6], breast surgery [7], laparoscopic cholecystectomy procedures [8] and PCNL[9, 10]. The peritubal infiltration along the renal capsule, subcutaneous tissue, skin and nephrostomy tube is carried out after PCNL is another effective method for postoperative analgesia.[11] There was no reported study for comparison of ESPB versus peritubal infiltration for postoperative analgesia for PCNL. The aim of this randomized, controlled, single-blinded study was to compare the analgesic efficacy of ultrasound-guided ESPB versus peritubal infiltration versus no intervention. |