Peritubal Infiltration of Bupivacaine in PCNL

• Sponsor: Indus Hospital and Health Network (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02198027
• Collaborator: (none)
• Enrollment: 68
• Location: 1
• Arms: 2
• Duration (Months): 5
• Patients Per Site Per Month: 13.5

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Pain	Drug: Bupivacaine; Other: Normal saline infiltration	Phase 4

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Role of Peritubal Infiltration of 0.25% Bupivacaine in Percutaneous Nephrolithotomy (PCNL) in Postoperative Pain Control
• Study Start Date: Jul 1, 2014
• Anticipated Primary Completion Date: Dec 1, 2014
• Anticipated Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bupivacaine infiltration 10 ml of 0.25 % Bupivacaine	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.
Placebo Comparator: Normal saline infiltration 10 ml of normal saline	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; Other Names: normal saline

Outcome Measures

Primary Outcome Measures

1. Mean time for first demand of rescue analgesic [Release of the patient from the hospital or 24 hours (whichever comes first)]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Indus Hospital	Karachi	Sind	Pakistan

Sponsors and Collaborators

• Indus Hospital and Health Network

Investigators

• Principal Investigator: Zeeshan Arshad, MBBS, The Indus Hospital
• Study Director: Zafar Zaidi, MBBS, The Indus Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zeeshan Arshad, Resident, Urology, Indus Hospital and Health Network
• ClinicalTrials.gov Identifier: NCT02198027
• Other Study ID Numbers: TIH-Urology-001; IRD_IRB_2014_01_002
• First Posted: Jul 23, 2014
• Last Update Posted: Sep 23, 2014
• Last Verified: Sep 1, 2014

• Keywords provided by Zeeshan Arshad, Resident, Urology, Indus Hospital and Health Network: Percutaneous nephrolithotomy; postoperative analgesia; peritubal block; pain; Visual Analog Pain Scale
• Additional relevant MeSH terms: Bupivacaine

Study Results

No Results Posted as of Sep 23, 2014