Comparison of Post-Operative Analgesia After Percutaneous Nephrolithotomy.

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04835116
• Other study ID #: AFIU Rawalpindi
• Status: Completed
• Phase: Phase 4
• Start date: April 11, 2019
• Est. completion date: October 11, 2019

Study information

• Verified date: April 2021
• Source: Armed Forces Institute of Urology, Rawalpindi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: October 11, 2019
• Est. primary completion date: October 11, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pain
• Pain, Postoperative
• Postoperative Pain

Intervention

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.
• 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

Locations

Country	Name	City	State
Pakistan	Armed Forces Institute of Urology.	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Armed Forces Institute of Urology, Rawalpindi

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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