Peritubal Infiltration of Bupivacaine in PCNL

Pain Clinical Trial

Official title:

Role of Peritubal Infiltration of 0.25% Bupivacaine in Percutaneous Nephrolithotomy (PCNL) in Postoperative Pain Control

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02198027
• Other study ID #: TIH-Urology-001
• Secondary ID: IRD_IRB_2014_01_
• Status: Recruiting
• Phase: Phase 4
• First received: July 21, 2014
• Last updated: September 20, 2014
• Start date: July 2014
• Est. completion date: December 2014

Study information

• Verified date: September 2014
• Source: Indus Hospital
• Contact: Zeeshan Arshad, MBBS
• Email: zeeshandaa[@]hotmail.com
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Patients may feel significant pain at the surgery site after they wake up from the surgery. Usually pain is managed in the ward by giving strong pain medication that may slow down your mobilization and recovery process. Some recent work in other countries has shown that if investigator give patients an injection at the end of the operation, patients have less need for pain medication when they wake up. If investigator find that is also true in our population, then we can use this method as routine step after this operation to improve pain management and early mobilization of our patients

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 68
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Age 18-60 years of age

• Single PCNL track

Exclusion Criteria:

• Spinal Disc Prolapse

• Any previous renal surgery

• Complication secondary to PCNL

• Hydrothorax that requires intervention

• Pneumothorax

• Massive hemorrhage that requires more than 1 U transfusion

• Conversion to open procedure.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Bupivacaine
23 G spinal needle will be introduced along the nephrostomy tube for peri-tubal infiltration of 10 ml of 0.25 % Bupivacaine into renal capsule to skin.

Other:
• Normal saline infiltration
23 G spinal needle will be introduced along the nephrostomy tube for peri-tubal infiltration of 10 ml of normal saline into renal capsule to skin

Locations

Country	Name	City	State
Pakistan	The Indus Hospital	Karachi	Sind

Sponsors (1)

Lead Sponsor	Collaborator
Indus Hospital

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean time for first demand of rescue analgesic	Mean time for first demand defined as the difference in time between the first time rescue medications is given to patient in post-operatively and the time the infiltration took place intra-operatively	Release of the patient from the hospital or 24 hours (whichever comes first)	No