Comparative Study of Ultrasound-guided Paravertebral Block Versus Intravenous Tramadol for Postoperative Pain Control in Percutaneous Nephrolithotomy
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Cukurova University
- Enrollment
- 53
- Locations
- 1
- Primary Endpoint
- Visual Analogue Scale
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 (Device)
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 (Procedure)
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 (Drug)
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 (Drug)
Group tramadol
Patients in group T were given a loading dose of tramadol of 1 mgkg-1
Intervention: Group Tramadol (Drug)
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)
Investigators
Zehra
Assistant professor
Cukurova University