Peritubal Infiltration of Bupivacaine in PCNL
Role of Peritubal Infiltration of 0.25% Bupivacaine in Percutaneous Nephrolithotomy (PCNL) in Postoperative Pain Control
2 other identifiers
interventional
68
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4 pain
Started Jul 2014
Shorter than P25 for phase_4 pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 21, 2014
CompletedFirst Posted
Study publicly available on registry
July 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedSeptember 23, 2014
September 1, 2014
5 months
July 21, 2014
September 20, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (2)
Bupivacaine infiltration
EXPERIMENTAL10 ml of 0.25 % Bupivacaine
Normal saline infiltration
PLACEBO COMPARATOR10 ml of normal saline
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- Age 18-60 years of age
- Single PCNL track
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Indus Hospital
Karachi, Sindh, Pakistan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zeeshan Arshad, MBBS
The Indus Hospital
- STUDY DIRECTOR
Zafar Zaidi, MBBS
The Indus Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident, Urology
Study Record Dates
First Submitted
July 21, 2014
First Posted
July 23, 2014
Study Start
July 1, 2014
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
September 23, 2014
Record last verified: 2014-09