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Trial registered on ANZCTR


Registration number
ACTRN12617000431325
Ethics application status
Approved
Date submitted
13/02/2017
Date registered
24/03/2017
Date last updated
24/03/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The effect of peritubal infiltration with bupivacaine and morphine on postoperative analgesia in patients undergoing percutaneous nephrolithotomy
Scientific title
The effect of peritubal infiltration with bupivacaine and morphine on postoperative analgesia in patients undergoing percutaneous nephrolithotomy
Secondary ID [1] 291177 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
postoperative analgesia 302055 0
Kidney stones 302161 0
Condition category
Condition code
Anaesthesiology 301688 301688 0 0
Pain management
Surgery 301689 301689 0 0
Other surgery
Renal and Urogenital 301690 301690 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients underwent spinoepidural anesthesia. The patients ' demographic data recorded. The patients were divided into two groups. Patients distributde to groups with closed envelope technique.
Group P (n=66): Peritubal infiltration group was given 0.25% bupivacaine [Bustesin(R), Vem, Ankara, Turkey] 20 mL + 5 mg morphine (0.5 ml) [Morphine HCl(R), Galen, Istanbul, Turkey] into the renal capsule, peripheral fat tissue, muscle tissue, subcutaneous tissues and skin after a nephrostomy tube was inserted using a 22G spinal needle advanced towards 6 and 12 O’clock positions as guided by a fluoroscopy along nephrostomy catheter by urologist at the end of the surgery. The anesthetic solution was observed by fluoroscopy, which was evenly distributed throughout the nephrostomy catheter.
Postoperative pain control was achieved with epidural patient-controlled analgesia (PCA)(CADD-Legacy(R) PCA, Smiths Medical, St Paul, USA) for the first 24 hours post surgery. Epidural PCA was prepared including 40 mL 0.5% bupivacaine + 500 mcg fentanyl +
110 mL 0.9% NaCl, to a total of 160 mL epidural solution as postoperative analgesic for all
patients . Without a basal infusion,
bolus dose was set as 5 mL, key duration as 20 min and hourly limit as 15 mL.
In first 24 h pain scores, time of the first analgesic demand, the mean number of analgesic demands and postoperative complications were compared between groups.
Intervention code [1] 297174 0
Treatment: Drugs
Comparator / control treatment
Group C (n=64): control group. None of the patients received a peritubal injection. Postoperative pain control was achieved with epidural patient-controlled analgesia (PCA).
Control group
Active

Outcomes
Primary outcome [1] 301080 0
rate of analgesic consumption in the 24 hours after surgery

Datas of analgesic agent consumption are assessed by review of medical records. Analgesic consumption will be calculated by the total amount of analgesic agents spent on Patient-controlled analgesia (PCA)
Timepoint [1] 301080 0
24 hours after surgery
Primary outcome [2] 301081 0
Pain, assessed by visual analogue scale at rest and during movement.
Timepoint [2] 301081 0
at 0-2-4-8-12-24. hours
Secondary outcome [1] 331684 0
Postoperative complications were assessed according to the Modified Clavien classification (MCC) (Fever (higher than 38 degrees), Emezis, Vomiting, Headache, Itching, Blood transfusion, Infection, Arteriovenous fistula, Acute Coronary Syndrome, i.e)
Adverse events were recorded. If adverse events were recognized,
This complications listed were assessed as recorded by treating clinician in the medical records
Timepoint [1] 331684 0
during intraoperative process and 24 hours post surgery

Eligibility
Key inclusion criteria
-patients who underwent percutaneous nephrolithotomy
- aged between 18 and 65 years,
-whose the American Society of Anesthesiologists (ASA) score was I-III,
-body mass index was <30 kg/m2,
-stone size measured >2 cm,
- duration of surgery was <3 h
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-allergic to local anesthetics or morphine,
- patients having a contraindication to neuro-axial block,
-patients given general anesthesia,
- those with a bleeding disorder,
-those having alcohol or substance abuse,
-patients who underwent surgical interventions from multiple sites
-patients who underwent bilateral PNL

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
25/05/2015
Date of last participant enrolment
Anticipated
Actual
23/05/2016
Date of last data collection
Anticipated
Actual
24/05/2016
Sample size
Target
130
Accrual to date
Final
130
Recruitment outside Australia
Country [1] 8658 0
Turkey
State/province [1] 8658 0
Bursa

Funding & Sponsors
Funding source category [1] 295620 0
Self funded/Unfunded
Name [1] 295620 0
Isra Karaduman
Country [1] 295620 0
Turkey
Primary sponsor type
Individual
Name
Isra Karaduman
Address
Health Sciences University Bursa Yuksek Ihtisas Training Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood /Emniyet Street/16310 Yildirim/Bursa
Country
Turkey
Secondary sponsor category [1] 294461 0
Individual
Name [1] 294461 0
Canan Yilmaz
Address [1] 294461 0
Health Sciences University Bursa Yuksek Ihtisas Training Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood /Emniyet Street/16310 Yildirim/Bursa
Country [1] 294461 0
Turkey

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296938 0
Bursa Yuksek Ihtisas Training and Education Hospital Clinical Researc Ethics Committee
Ethics committee address [1] 296938 0
Ethics committee country [1] 296938 0
Turkey
Date submitted for ethics approval [1] 296938 0
02/03/2015
Approval date [1] 296938 0
20/05/2015
Ethics approval number [1] 296938 0
2011-KAEK-25 2015/10-09

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68854 0
Dr Isra Karaduman
Address 68854 0
Health Sciences University Bursa Yuksek Ihtisas Training Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood /Emniyet Street/16310 Yildirim/Bursa
Country 68854 0
Turkey
Phone 68854 0
+905077561163
Fax 68854 0
Email 68854 0
isra.karaduman@saglik.gov.tr
Contact person for public queries
Name 68855 0
Isra Karaduman
Address 68855 0
Health Sciences University Bursa Yuksek Ihtisas Training Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood /Emniyet Street/16310 Yildirim/Bursa
Country 68855 0
Turkey
Phone 68855 0
+905077561163
Fax 68855 0
Email 68855 0
isra.karaduman@saglik.gov.tr
Contact person for scientific queries
Name 68856 0
Derya Karasu
Address 68856 0
Health Sciences University Bursa Yuksek Ihtisas Training Education Hospital Clinic of Anesthesiology and Reanimation
Mimar Sinan Neighborhood /Emniyet Street/16310 Yildirim/Bursa
Country 68856 0
Turkey
Phone 68856 0
+905057281175
Fax 68856 0
Email 68856 0
drderyatopuz@gmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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