Comparison of Post-Operative Analgesia After Percutaneous Nephrolithotomy.

Phase 4

Completed

• Conditions: Pain; Postoperative Pain
• Interventions: Drug: Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg.; Drug: paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg.

• Registration Number: NCT04835116
• Lead Sponsor: Armed Forces Institute of Urology, Rawalpindi

Brief Summary

The rationale of this study was to compare the efficacy of peri-tract bupivacaine infiltration with intravenous post-operative analgesia following PCNL in reference to the context with the previous studies so that we can adopt the better technique to curtail the post-operative pain.

Detailed Description

The rationale of this study was to compare the efficacy of peri-tract bupivacaine infiltration with intravenous postoperative analgesia following PCNL in reference to the context with the previous studies so that we can adopt the better technique to curtail the post-operative pain.

Study Timeline

• Study Start: 2019-04-11
• Primary Completion: 2019-10-11
• Study Completion: 2019-10-11
• Study First Submitted: 2021-03-28
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-04
• Study First Posted: 2021-04-08
• Last Update Submitted: 2021-04-10
• Last Update Posted: 2021-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• all patients undergoing PCNL
• age from 12-65 years
• normal renal functions
• no history of chronic pain
• ASA I, II & III
• Both genders

Exclusion Criteria

• history of local anaesthesia allergy
• Redo PCNL
• Multiple punctures during PCNL
• Excessive intra-operative bleeding
• Diabetes mellitus
• Coagulopathy
• Mental disorder
• ASA IV & V
• Active urinary tract infection.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Local Anesthesia	Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg.	Group A patients received peri tract local anaesthesia infiltration with 0.25% Bupivacaine.
Local Anesthesia	paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg.	Group A patients received peri tract local anaesthesia infiltration with 0.25% Bupivacaine.
Intravenous Analgesics	Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg.	Group B patients received postoperative intravenous analgesia.
Intravenous Analgesics	paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg.	Group B patients received postoperative intravenous analgesia.

Primary Outcome Measures

Name	Time	Method
Comparison of Post-Operative Analgesia With Peri Tract Local Anesthesia Infiltration and Oral Analgesia Versus Post-Operative Intravenous Analgesia After Percutaneous Nephrolithotomy.	6 months	Efficacy of peri-tract infiltration of bupivacaine over standard oral analgesia in patients undergoing PCNL.; Measurement: Postoperative pain Measurement tool: Visual analog scale

Trial Locations

Locations (1)

Armed Forces Institute of Urology.; 🇵🇰 Rawalpindi, Punjab, Pakistan