A clinical trial to compare the effect of drug ropivacaine when given via two routes, erector spinae plane block and peritubal local infiltration for post operative pain management in patients undergoing percutaneous nephrolithotomy surgery.

Phase 4

Not yet recruiting

• Conditions: Calculus of kidney, (2) ICD-10 Condition: N00-N99||Diseases of the genitourinary system,

• Registration Number: CTRI/2023/08/056925
• Lead Sponsor: Mahatma Gandhi Medical College And Hospital

Brief Summary

•      It is a hospital based randomized, comparative study to be conducted in Department of Anaesthesiology, Mahatma Gandhi Medical College & Hospital, Jaipur. After getting clearance from Institutional Ethics Committee and Clinical Trials Registry India (CTRI) registration and written informed consent, patients planned for percutaneous nephrolithotomy (PCNL) surgeries under general anaesthesia will be included in this study.

•      After doing all the required investigation, PAC will be performed a day before the surgery.

•      Patients would be randomly divided into two groups of 34 each with the help of computer-generated random numbers. All patients will be explained about the anaesthesia technique.

•      Group A - (n=34) will receive GA + Peritubal infiltration with 0.25% Ropivacaine 20 ml.

•      Group B - (n=34) will receive GA + ESP Block with 0.25% Ropivacaine 20ml

•      Following parameters will be monitored in all patients:

•      Post-Op VAS Scores at 30min, 60min, 2h, 4h, 8h, 12h, 16, 20h, 24h.

•      Time to first rescue analgesia.

•      Total consumption of analgesics in first 24 hours.

•      Patient satisfaction.

•      Occurrence of complication.

**TECHNIQUE FOR USG-GUIDED ESP BLOCK**

•      In the operation theatre, standard monitors will be attached such as an electrocardiograph, non-invasive blood pressure, pulse oximeter and etCO2.

•      General anaesthesia will be administered with i.v. fentanyl 2mcg/kg, propofol 2 mg/kg, and paralyzed with atracurium 0.5 mg/kg. Patient will be intubated with an appropriate size endotracheal tube after 3 minutes of bag & mask ventilation. After confirming the endotracheal tube position, the patient will be connected to the anaesthesia workstation.

•      Maintenance of anaesthesia will be done using nitrous oxide and oxygen mixture in a ratio of 60:40%, and isoflurane concentration will be adjusted to maintain minimum alveolar concentration (MAC) of 1 - 1.3. Patient will be positioned prone for the surgery with appropriate padding.

•      At the end of the surgery, Group B participants will receive ESP Block at T10 level by the principal investigator in prone position (20 mL of 0.25% Ropivacaine). T10 level will be identified and marked by counting from above using bony landmarks. A linear ultrasound probe (M-Turbo, Fujifilm, Sonosite) will be placed in transverse orientation in the midline and T10 spinous process will be identified. Then the probe is moved laterally (approx. 3cm towards operated side until the transverse process (TP) is visualized. The probe is then rotated 90°, and the USG landmarks including the TP, overlying erector spinae muscles and trapezius (thin hypoechoic layer), are identified.

•      All sterile aseptic precautions will be taken and the ultrasound machine will be placed on the opposite side of the back of the patient that has to be blocked. Under all aseptic precautions, 21G needle will be inserted parallel to the USG beam at an angle of 30-45 degrees in craniocaudal direction, till the tip of the needle comes in contact with TP. Once contacted, needle is withdrawn back few millimeters so as to reach into the fascial plane between erector spinae muscle and transverse process. The position of the needle tip will be checked by hydro-dissection with 2 ml normal saline; thereafter, a total of 0.25% Ropivacaine 20 ml will be injected. The spread of drug will be observed ultrasonographically.

Where as, Group A participants will receive 0.25% Ropivacaine 20mL peritubally (around nephrostomy tube) by the operating surgeon in prone

position.

**STUDY PARAMETERS**

The primary outcome of this study will be recording post-op pain score using VAS score after ESP Block or Peritubal infiltration of local anaesthetic and secondary

objectives will be recording time to firstrescueanalgesia, total consumption of analgesics in first 24 hours post operatively, patient satisfaction score and occurrence of any

complication. Patients will be observed for 24 hours after surgery in the post anaesthesia care unit by principal investigator. The pain score will be evaluated using Visual

Analogue scale (VAS) Score (0=no pain and 10= worst pain imaginable) on arrival in the post anaesthesia care unit at 30min, 60min, 2nd hour, 4th hour and then 4

hourly till 24 hours postoperatively (8th hour, 12th hour, 16th hour, 20th hour and 24th hour). Rescue analgesia will be provided if VAS score is ≥ 4 with i.v. tramadol

(@1mg/kg/dose, max 400mg in 24hours). If the pain is persisting (VAS ≥4) after 30 min of tramadol administration, paracetamol (@15mg/kg/dose, max 1 gram) i.v. will be

given as the second analgesic. The VAS scores will be further assessed according to the time line given in the protocol. The tramadol and paracetamol doses will be re-

administered if VAS ≥4 after 6h of the previous administration. If a VAS score of ≥ 4 is recorded in the intervening period, then i.v. fentanyl bolus of (0.5 mg/kg) will be

given. The patients will also be monitored for complications during block performance and postoperatively (local anaesthetic toxicity, pneumothorax, nausea, vomiting).

Patients having nausea and vomiting will be treated with ondansetron. The number of patients requiring rescue analgesia and total tramadol/paracetamol/fentanyl

consumption during the first 24 hours after surgery will be recorded. Any adverse events including hypotension, bradycardia, dry mouth, dizziness, diplopia, nausea, and

vomiting will be noted. Patient’s satisfaction with the anaesthesia technique will be assessed at 24 hours after surgery using a 5-point Likert’s satisfaction score (0=

completely unsatisfied to 5= most satisfied).

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-09
• Last Update Posted: 2023-06-08

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

1.Age (18-65) years 2.All genders 3.Patients with ASA grade I/II 4.Patients undergoing PCNL surgery under GA.

Exclusion Criteria

1.Infection at local site 2.H/o drug abuse, psychiatric disorder, chronic pain 3.Coagulation abnormalities 4.Pregnant or lactating females 5.Refusal for consent of peripheral nerve block 6.History of drug allergy.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the post operative pain score of two groups (Erector Spinae Plane Block & Peritubal infiltration of LA) using Visual Analogue Scale (VAS)	Post-operative pain score monitoring by VAS score at 30min, 60min, 2h, 4h, 8h, 12h, 16h, 20h & 24hour.

Secondary Outcome Measures

Name	Time	Method
1) To compare time to first rescue analgesia in both groups.	2) To compare total consumption of analgesics in first 24 hours post operatively.

Trial Locations

Locations (1)

Mahatma Gandhi Medical College And Hospital; 🇮🇳 Jaipur, RAJASTHAN, India

Mahatma Gandhi Medical College And Hospital

🇮🇳Jaipur, RAJASTHAN, India

Dr Harsimran Singh

Principal investigator

8076481208

harsimransingh115@gmail.com