Comparison of Post-Operative Analgesia After Percutaneous Nephrolithotomy.

• ClinicalTrials.gov Identifier: NCT04835116
• Recruitment Status: Completed
• First Posted: April 8, 2021
• Last Update Posted: April 14, 2021
• Sponsor: Armed Forces Institute of Urology, Rawalpindi
• Information provided by (Responsible Party): Musab Umair Khalid, Armed Forces Institute of Urology, Rawalpindi

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pain; Postoperative Pain	Drug: Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg.; Drug: paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg.	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Comparison of Post-Operative Analgesia With Peri Tract Local Anesthesia Infiltration and Oral Analgesia Versus Post-Operative Intravenous Analgesia After Percutaneous Nephrolithotomy.
• Actual Study Start Date: April 11, 2019
• Actual Primary Completion Date: October 11, 2019
• Actual Study Completion Date: October 11, 2019

Arms and Interventions

Arm	Intervention/treatment
Local Anesthesia; Group A patients received peri tract local anaesthesia infiltration with 0.25% Bupivacaine.	Drug: Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg.; 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.; Other Name: Local Anesthesia; Drug: paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg.; 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; Other Name: Intravenous analgesic
Intravenous Analgesics; Group B patients received postoperative intravenous analgesia.	Drug: Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg.; 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.; Other Name: Local Anesthesia; Drug: paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg.; 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; Other Name: Intravenous analgesic

Outcome Measures

Primary Outcome Measures :

1. Comparison of Post-Operative Analgesia With Peri Tract Local Anesthesia Infiltration and Oral Analgesia Versus Post-Operative Intravenous Analgesia After Percutaneous Nephrolithotomy. [ Time Frame: 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

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 65 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Pakistan

Armed Forces Institute of Urology.

Rawalpindi, Punjab, Pakistan, 47040

Sponsors and Collaborators

Armed Forces Institute of Urology, Rawalpindi

Investigators

• Principal Investigator: Musab Umair, MBBS; Armed Forces Institute of Urology.

More Information

• Responsible Party: Musab Umair Khalid, Doctor, Armed Forces Institute of Urology, Rawalpindi
• ClinicalTrials.gov Identifier: NCT04835116
• Other Study ID Numbers: AFIU Rawalpindi
• First Posted: April 8, 2021
• Last Update Posted: April 14, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Keywords provided by Musab Umair Khalid, Armed Forces Institute of Urology, Rawalpindi:

Local anesthesia, Percutaneous nephrolithotomy.

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Acetaminophen; Tramadol; Analgesics; Orphenadrine; Dimenhydrinate; Bupivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Analgesics, Non-Narcotic; Antipyretics; Analgesics, Opioid; Narcotics; Antiparkinson Agents; Anti-Dyskinesia Agents; Muscle Relaxants, Central; Neuromuscular Agents; Parasympatholytics; Autonomic Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents