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Clinical Trials/NCT02412930
NCT02412930
Completed
Phase 4

Comparative Study of Ultrasound-guided Paravertebral Block Versus Intravenous Tramadol for Postoperative Pain Control in Percutaneous Nephrolithotomy

Cukurova University1 site in 1 country53 target enrollmentMarch 2012

Overview

Phase
Phase 4
Intervention
Ultrasound
Conditions
Postoperative Pain
Sponsor
Cukurova University
Enrollment
53
Locations
1
Primary Endpoint
Visual Analogue Scale
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2012
End Date
April 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zehra

Assistant professor

Cukurova University

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.

Arms & Interventions

Group Paravertebral Block

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.

Intervention: Ultrasound

Group Paravertebral Block

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.

Intervention: Ultrasound-guided Paravertebral Block

Group Paravertebral Block

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.

Intervention: Group Tramadol

Group Paravertebral Block

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.

Intervention: Bupivacaine

Group tramadol

Patients in group T were given a loading dose of tramadol of 1 mgkg-1

Intervention: Group Tramadol

Outcomes

Primary Outcomes

Visual Analogue Scale

Time Frame: up to 24 hours

Postoperative pain degree was evaluated by Visual Analogue Scale

Secondary Outcomes

  • tramadol consumption(up to 24 hours)

Study Sites (1)

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