- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02198027
Peritubal Infiltration of Bupivacaine in PCNL
September 20, 2014 updated by: Zeeshan Arshad, Indus Hospital and Health Network
Role of Peritubal Infiltration of 0.25% Bupivacaine in Percutaneous Nephrolithotomy (PCNL) in Postoperative Pain Control
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
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
68
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Zeeshan Arshad, MBBS
- Email: zeeshandaa@hotmail.com
Study Locations
-
-
Sind
-
Karachi, Sind, Pakistan
- Recruiting
- The Indus Hospital
-
Principal Investigator:
- Zeeshan Arshad, MBBS
-
Sub-Investigator:
- Zafar Zaidi, MBBS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bupivacaine infiltration
10 ml of 0.25 % 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
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean time for first demand of rescue analgesic
Time Frame: 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
|
Release of the patient from the hospital or 24 hours (whichever comes first)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Zeeshan Arshad, MBBS, The Indus Hospital
- Study Director: Zafar Zaidi, MBBS, The Indus Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Anticipated)
December 1, 2014
Study Completion (Anticipated)
December 1, 2014
Study Registration Dates
First Submitted
July 21, 2014
First Submitted That Met QC Criteria
July 22, 2014
First Posted (Estimate)
July 23, 2014
Study Record Updates
Last Update Posted (Estimate)
September 23, 2014
Last Update Submitted That Met QC Criteria
September 20, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TIH-Urology-001
- IRD_IRB_2014_01_002 (Other Identifier: IRD IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
Clinical Trials on Bupivacaine
-
Hospital Civil de GuadalajaraRecruitingEffect of Subarachnoid Hyperbaric Bupivacaine in Obese Pregnant Patients Undergoing Cesarean SectionAnesthesia | Obstetric Anesthesia ProblemsMexico
-
Hospital Civil de GuadalajaraCompletedAnesthesia, ObstetricalMexico
-
DurectNycomedCompletedPostoperative PainAustria, Germany, Latvia, Poland, Sweden
-
DurectNycomedCompletedPostoperative PainFrance, Germany, Hungary, Latvia, Sweden, United Kingdom
-
Indiana UniversityCompletedPain, Postoperative | Acute Pain | ThoracicUnited States
-
Seoul National University HospitalUnknownAnesthesia, Spinal [E03.155.086.331] | Operating Tables [E07.325.662]Korea, Republic of
-
Vanderbilt University Medical CenterCompletedAnesthesia | Breast Reconstruction | Transverse Abdominis Plane BlockUnited States
-
Coordinación de Investigación en Salud, MexicoInstituto Mexicano del Seguro SocialCompletedObstetric PainMexico
-
Indiana UniversityCompleted
-
University of Texas Southwestern Medical CenterCompleted