Comparative Study of Ultrasound-guided Paravertebral Block Versus Intravenous Tramadol in Percutaneous Nephrolithotomy
Primary Purpose
Postoperative Pain
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Ultrasound-guided Paravertebral Block
Group Tramadol
Bupivacaine
Ultrasound
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- 53 patients scheduled for percutaneous nephrolithotomy (PNL),
- 18-70 years of age,
- weight between 50-100 kg,
- American Society of Anesthesiologists (ASA) classification I-II were included
Exclusion Criteria:
- The exclusion criteria were refusals by patients,
- coagulation abnormalities,
- patients with spinal deformity,
- cutaneous infection at the injection site and
- a known allergy to drugs.
Sites / Locations
- Cukurova University Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Group Paravertebral Block
Group tramadol
Arm Description
With ultrasound guidance at T10 to L1 levels, using 0.5% bupivacaine total dose of 15 mL in group P. 5 mL bupivacaine 0.5% was injected in each dermatome level.
Patients in group T were given a loading dose of tramadol of 1 mgkg-1
Outcomes
Primary Outcome Measures
Visual Analogue Scale
Postoperative pain degree was evaluated by Visual Analogue Scale
Secondary Outcome Measures
tramadol consumption
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02412930
Brief Title
Comparative Study of Ultrasound-guided Paravertebral Block Versus Intravenous Tramadol in Percutaneous Nephrolithotomy
Official Title
Comparative Study of Ultrasound-guided Paravertebral Block Versus Intravenous Tramadol for Postoperative Pain Control in Percutaneous Nephrolithotomy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
March 2012 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cukurova University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Paravertebral block has been widely used for analgesia. The aim of this study,comparison of the effect of ultrasound-guided paravertebral block versus intravenous tramadol for postoperative pain control in percutaneous nephrolithotomy.
Detailed Description
The study protocol was approved by the Local Ethical Committee. Written informed consent was obtained from all patients, before starting to surgery.
The patients were given no premedication. The demographic data of patients (age, gender, the presence of other diseases) were recorded, preoperatively. All patients were applied standard monitoring in the operating room. After the induction of anesthesia provided intravenously propofol (2-3mg/kg) and rocuronium bromide (0.5 mgkg-1), all patients were intubated with a suitable endotracheal tube. Anesthesia maintenance was provided with 1-2% sevoflurane and a 60% nitrous oxide-40% oxygen gas mixture. 0.9% NaCl (5-10 mLkg-1) was started as fluid resuscitation. Urinary catheter was inserted before placement, and then all patients were placed in the prone position.
Postoperatively, duration of surgery, systolic and diastolic blood pressures, heart rate, peripheral oxygen saturation (SBP, DBP, HR, and SpO2), visual analog scales (VAS), side effects such as vomiting and nausea, complications such as pneumothorax, tramadol consumption and additional analgesic requirements of patients were recorded at 1, 2, 4, 6, 12 and 24 h in the postoperative period. These parameters were evaluated by an anesthesiologist in the first 24 hours postoperatively. If the VAS score was >4, patients in both groups were administered diclofenac.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group Paravertebral Block
Arm Type
Active Comparator
Arm Description
With ultrasound guidance at T10 to L1 levels, using 0.5% bupivacaine total dose of 15 mL in group P. 5 mL bupivacaine 0.5% was injected in each dermatome level.
Arm Title
Group tramadol
Arm Type
Placebo Comparator
Arm Description
Patients in group T were given a loading dose of tramadol of 1 mgkg-1
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided Paravertebral Block
Intervention Description
paravertebral block was performed by ultrasound guidance at T11, T12 and L1 levels, using 0.5% bupivacaine total dose of 15 mL in group P. The injection site was covered with sterile drapes, after cleaning with 10% povidone-iodine solution.
After, patients in both groups were performed patient controlled analgesia (PCA). The PCA was prepared with 400 mg tramadol into 100 mL of saline. The doses of tramadol in the PCA were bolus dose 0.1 mgkg-1 every 20 minutes without a background infusion.
Intervention Type
Drug
Intervention Name(s)
Group Tramadol
Intervention Description
Patients in group T were given intravenously a loading dose of tramadol of 1 mgkg-1, 45 minutes before the end of surgery. After,patients in both groups were performed patient controlled analgesia (PCA). The PCA (CADD Legacy PCA pump, Smiths Medical MD, Inc., St. Paul, MN) was prepared with 400 mg tramadol into 100 mL of saline. The doses of tramadol in the PCA were bolus dose 0.1 mgkg-1 every 20 minutes without a background infusion.
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Type
Device
Intervention Name(s)
Ultrasound
Primary Outcome Measure Information:
Title
Visual Analogue Scale
Description
Postoperative pain degree was evaluated by Visual Analogue Scale
Time Frame
up to 24 hours
Secondary Outcome Measure Information:
Title
tramadol consumption
Time Frame
up to 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
53 patients scheduled for percutaneous nephrolithotomy (PNL),
18-70 years of age,
weight between 50-100 kg,
American Society of Anesthesiologists (ASA) classification I-II were included
Exclusion Criteria:
The exclusion criteria were refusals by patients,
coagulation abnormalities,
patients with spinal deformity,
cutaneous infection at the injection site and
a known allergy to drugs.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zehra Hatipoğlu, Assist Prof
Organizational Affiliation
Cukurova University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cukurova University Faculty of Medicine
City
Adana
ZIP/Postal Code
01230
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
29454333
Citation
Hatipoglu Z, Gulec E, Turktan M, Izol V, Aridogan A, Gunes Y, Ozcengiz D. Comparative study of ultrasound-guided paravertebral block versus intravenous tramadol for postoperative pain control in percutaneous nephrolithotomy. BMC Anesthesiol. 2018 Feb 17;18(1):24. doi: 10.1186/s12871-018-0479-7.
Results Reference
derived
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Comparative Study of Ultrasound-guided Paravertebral Block Versus Intravenous Tramadol in Percutaneous Nephrolithotomy
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