Comparison of Post-Operative Analgesia After Percutaneous Nephrolithotomy.

NCT04835116 | Completed Phase 4 DMC

• 1 other identifier: AFIU Rawalpindi
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Postoperative Pain

Keywords

Local anesthesia, Percutaneous nephrolithotomy.

Outcome Measures

Primary Outcomes (1)

• Comparison of Post-Operative Analgesia With Peri Tract Local Anesthesia Infiltration and Oral Analgesia Versus Post-Operative Intravenous Analgesia After Percutaneous Nephrolithotomy.

  Efficacy of peri-tract infiltration of bupivacaine over standard oral analgesia in patients undergoing PCNL. Measurement: Postoperative pain Measurement tool: Visual analog scale

  6 months

Study Arms (2)

Local Anesthesia

OTHER

Group A patients received peri tract local anaesthesia infiltration with 0.25% Bupivacaine.

Drug: Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg.; Drug: paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg.

Intravenous Analgesics

OTHER

Group B patients received postoperative intravenous analgesia.

Drug: Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg.; Drug: paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg.

Interventions

Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg. DRUG

Group A patients were administered per-operative peri tract local anesthesia infiltration with 0.25% bupivacaine augmented by post-operative oral analgesia with a combination of Paracetamol 650 mg and Orphenadrine 50mg 6 hourly.

Also known as: Local Anesthesia

Intravenous Analgesics; Local Anesthesia

paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg. DRUG

Group B patients were only given post-operative intra-venous analgesia by Paracetamol 1gm intravenous 8 hourly augmented with a combination of Tramadol 50mg and Dimenhydrinate 50mg as and when required

Also known as: Intravenous analgesic

Intravenous Analgesics; Local Anesthesia

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Armed Forces Institute of Urology, Rawalpindi: lead

Study Sites (1)

Armed Forces Institute of Urology.

Rawalpindi, Punjab Province, 47040, Pakistan

Location

MeSH Terms

Conditions

Pain; Pain, Postoperative

Interventions

Bupivacaine; Anesthesia, Local

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Musab Umair, MBBS

  Armed Forces Institute of Urology.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: March 28, 2021
• First Posted: April 8, 2021
• Study Start: April 11, 2019
• Primary Completion: October 11, 2019
• Study Completion: October 11, 2019
• Last Updated: April 14, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)