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Comparative Study of Ultrasound-guided Paravertebral Block Versus Intravenous Tramadol in Percutaneous Nephrolithotomy

Phase 4
Completed
Conditions
Postoperative Pain
Interventions
Procedure: Ultrasound-guided Paravertebral Block
Device: Ultrasound
Registration Number
NCT02412930
Lead Sponsor
Cukurova University
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
53
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Group tramadolGroup TramadolPatients in group T were given a loading dose of tramadol of 1 mgkg-1
Group Paravertebral BlockUltrasound-guided Paravertebral BlockWith 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.
Group Paravertebral BlockGroup TramadolWith 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.
Group Paravertebral BlockBupivacaineWith 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.
Group Paravertebral BlockUltrasoundWith 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.
Primary Outcome Measures
NameTimeMethod
Visual Analogue Scaleup to 24 hours

Postoperative pain degree was evaluated by Visual Analogue Scale

Secondary Outcome Measures
NameTimeMethod
tramadol consumptionup to 24 hours

Trial Locations

Locations (1)

Cukurova University Faculty of Medicine

🇹🇷

Adana, Turkey

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