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

Çukurova University

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Group Tramadol; Device: Ultrasound; Drug: Bupivacaine; Procedure: Ultrasound-guided Paravertebral Block

Study type: Interventional

Funder types: Other

Identifiers

NCT02412930

5/8-2012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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53 participants in 2 patient groups, including a placebo group

Group Paravertebral Block

Active Comparator group

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.

Treatment:

Procedure: Ultrasound-guided Paravertebral Block

Device: Ultrasound

Drug: Group Tramadol

Drug: Bupivacaine

Group tramadol

Placebo Comparator group

Description:

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

Treatment:

Drug: Group Tramadol