Comparative Study of Ultrasound-guided Paravertebral Block Versus Intravenous Tramadol in Percutaneous Nephrolithotomy
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

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.
    

Intervention name(s): Ultrasound-guided Paravertebral Block; Group Tramadol; Bupivacaine; Ultrasound
Intervention type(s): Procedure; Drug; Drug; Device
Intervention description(s): 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.; 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 MeSH terms: Tramadol; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment