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CTRI Number  CTRI/2019/01/017051 [Registered on: 11/01/2019] Trial Registered Prospectively
Last Modified On: 12/08/2023
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   Erector Spinae Plane Block(Nerve block) for pain relief after percutaneous nephrolithotomy surgery 
Scientific Title of Study   Ultrasound Guided Erector Spinae Plane Block for Postoperative Analgesia in Patients undergoing Percutaneous Nephrolithotomy – A Double-blinded, Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vimi Rewari 
Designation  Professor 
Affiliation  AIl India Institute of Medical Sciences 
Address  Department of Anaesthesiology,Pain medicine and Critical care, Room No. 5007, Teaching block,AIIMS, Ansari Nagar

South
DELHI
11029
India 
Phone  9818304880  
Fax    
Email  vimirewari@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Vimi Rewari 
Designation  Professor 
Affiliation  AIl India Institute of Medical Sciences 
Address  Department of Anaesthesiology,Pain Medicine and Critical care, Room no. 5007, Teaching Block,AIIMS,Ansari Nagar

South
DELHI
11029
India 
Phone  9818304880  
Fax    
Email  vimirewari@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Yokasekar V 
Designation  Junior Resident 
Affiliation  AIl India Institute of Medical Sciences 
Address  Department of Anaesthesiology,Pain medicine and Critical care,AIIMS,Ansari Nagar

South
DELHI
11029
India 
Phone  7402226997  
Fax    
Email  yokasekarvenkatesan@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology,Pain Medicine and Critical Care ,AIIMS,New Delhi 
 
Primary Sponsor  
Name  Vimi Rewari 
Address  Department of Anaesthesiology,Pain Medicine and Critical Care ,AIIMS,New Delhi 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Department of AnaesthesiologyPain Medicine and Critical Care   AIIMS,Ansari Nagar,New Delhi -110029 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Vimi Rewari  AIIMS, Ansari Nagar, New Delhi -110029  Department of Anaesthesiology,Pain Medicine and Critical Care, Room No 5012,Academic Block
South
DELHI 
9818304880

vimirewari@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee,AIIMS,New Delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: N200||Calculus of kidney,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  General anaesthesia with intravenous opioids for analgesia   These patients will be administered intravenous opioids for perioperative analgesia 
Intervention  General anaesthesia with Unilateral Erector Spinae Plane block with 20 ml of 0.5% Ropivacaine  Erector Spinae Plane block is a interfascial nerve block which provides both visceral and somatic analgesia .This will be administered after general anaesthesia for perioperative analgesia. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.ASA grade I -III patients
2.Patients scheduled to undergo elective percutaneous nephrolithotomy surgery under general anaesthesia
 
 
ExclusionCriteria 
Details  1.Patient refusal to participate
2.BMI ≥ 35 kg/m2
3.Known hypersensitivity to local anaesthetic and opioids
4.Patient having infection at the site of block
5.Patient having spinal deformities and previous history of spine surgery
6.History of coagulopathy and on anticoagulant therapy
7.Patients with history of psychiatric illness and patients who are unable to comprehend instructions
 
 
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 
1. Total postoperative morphine consumption at 24 hours  24 hours postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 

1. Total intraoperative fentanyl requirement
2. Time to activation of IV morphine PCA pump postoperatively
3. Postoperative pain at rest and on coughing as assessed by VAS scale at 1hour, 2hours, 4 hours, 6hours, 12hours and 24hours postoperatively
4. Incidence of opioid-related adverse effects such as nausea and vomiting, respiratory depression and sedation
5. Requirement of rescue analgesics
6. Patient satisfaction score

 
1hour, 2hours, 4 hours, 6hours, 12hours and 24hours postoperatively 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="54" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/02/2019 
Date of Study Completion (India) 26/08/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Not yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Percutaneous nephrolithotomy (PCNL), a minimally invasive surgical procedure used to treat patients with large kidney stones (1), is usually associated with significant pain in the perioperative period. PCNL is performed in the prone position and although neuraxial anaesthesia has been successfully employed for the procedure, most patients and physicians prefer general anaesthesia for the same (2).

Intravenous analgesics such as opioids are routinely employed for the management of intraoperative and postoperative pain in these patients. These are often associated with significant adverse effects such as nausea and vomiting, pruritis and respiratory depression which may affect the postoperative course in these patients (3). Nonsteroidal anti-inflammatory (NSAID) drugs are of limited use in these patients as they are likely to have deranged kidney function tests (4).

In order to minimize the adverse effects of intravenous analgesics and to optimize perioperative analgesia, supplemental regional analgesia techniques such as epidural block, paravertebral block and intercostal nerve block have been used for the management of pain (5),(6). Epidural anaesthesia may be associated with complications like paraplegia, cauda equina syndrome, epidural hematoma, infection, intravascular injection, urinary retention etc. Although these complications are rare, they are severe enough to pose high morbidity to the patient (3). Thoracic paravertebral block is also as effective as epidural anaesthesia but is more technically demanding and requires multilevel injections to achieve large dermatomal coverage (7).

The ultrasound-guided erector spinae plane (ESP) block is a recently described technique which involves injection of local anaesthetic in plane deep to erector spinae muscle.Cadaveric investigation indicates that injection of 20-mL solutioninto the fascial plane deep to the erector spinae muscle at the levelof the T5 transverse process can result in injectate spread betweenthe C7 and T8 vertebral levels. Given that the erector spinae muscleextends inferiorly to the lumbar spine, injection into the ESP ata lower vertebral level (e.g, T7 or T8) should result in spread to thelower thoracoabdominal nerves as well. In addition, because the mechanism of action of the ESP block involvespenetration of local anaesthetic into the thoracic paravertebralspace, it anaesthetizes not only the ventral rami of spinal nerves but also the rami communicantes that contain sympathetic nervefibers. The ESP block thus has the potential to provide both somaticand visceral sensory blockade (8), (9).

The main sources of acute pain after PCNL are visceral pain originating from the kidneys and ureters and somatic pain from the incision site. Visceral pain is conducted largely through T10–L2 spinal nerves whereas the cutaneous innervation of the incision site is by the T8–T12 nerves. Thus, ESPB would likely be a good regional anaesthetic technique for PCNL (3), (10).

Also, the literature suggests that it is easier to perform as landmarks for the identification of the site of block are readily identifiable and good dermatomal coverage with a single puncture. Another important advantage lies in that the block site is away from major vascular structures and pleura and therefore is associated with less incidence of complications as compared to PVB (8).

We hypothesized that ESPB would be a good adjunct for providing perioperative analgesia and lead to reduction in total opioid consumption in the perioperative period following PCNL. Although ESPB has been used for many procedures, there is no data till date for its use for the management of pain in patients undergoing percutaneous nephrolithotomy. Hence, we aim to assess the efficacy of ESPB in providing perioperative analgesia in patients undergoing PCNL.

References

 

1.            1.Vicentini FC, Gomes CM, Danilovic A, ChedidNeto EA, Mazzucchi E, et al. Percutaneous nephrolithotomy: Current concepts. Indian J Urol2009;25:4-10.

2.            2. Hu H, Qin B, He D, Lu Y, Zhao Z, Zhang J,et al. Regional versus General Anesthesia forPercutaneous Nephrolithotomy: A Meta-Analysis.PLoS ONE 2015;10(5): e0126587.

3.           3. Miller’s Anesthesia eighth edition, Ronald D. Miller, MD, MS, Neal H. Cohen, MD, MS, MPH, Lars I. Eriksson, MD, PhD, FRCA, Lee A. Fleisher, MD, Jeanine P. Wiener-Kronish, MD, William L. Young, MD.

4.            4. Hörl WH. Nonsteroidal Anti-Inflammatory Drugs and the Kidney.Pharmaceuticals (Basel). 2010; 3(7): 2291–2321.

5.           5.  Li C, Song C, Wang W, Song C, Kong X. Thoracic Paravertebral Block versus Epidural Anesthesia Combined with Moderate Sedation for Percutaneous Nephrolithotomy.Med Princ Pract. 2016 Aug; 25(5): 417–422.

6.     6. Ozkan, D., Akkaya, T., Karakoyunlu, N. et al. Effect of ultrasound-guided intercostal nerve block on postoperative pain after percutaneous nephrolithotomy.Anaesthesist. 2013 Dec;62(12):988-94.

7.       7. El-Boghdadly, K., Madjdpour, C., & Chin, K. J. (2016). Thoracic paravertebral blocks in abdominal surgery – a systematic review of randomized controlled trials.Br J Anaesth. 2016 Sep;117(3):297-308.

8.            8. Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The erector spinae plane block: anovel analgesic technique in thoracic neuropathic pain. RegAnesth Pain Med2016;41:621–7.


 
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