Clinical trial NCT02412930: Comparative Study of Ultrasound-guided Paravertebral Block Versus Intravenous Tramadol in Percutaneous Nephrolithotomy
Official title: Comparative Study of Ultrasound-guided Paravertebral Block Versus Intravenous Tramadol for Postoperative Pain Control in Percutaneous Nephrolithotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Lead sponsor: Cukurova University
Sponsor class: OTHER
First posted: 2015-04-09
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Visual Analogue Scale
timeFrame: up to 24 hours
Secondary outcomes:
measure: tramadol consumption
timeFrame: up to 24 hours
Other outcomes:
Locations:
city: Adana
country: Turkey
facility: Cukurova University Faculty of Medicine
Study officials:
affiliation: Cukurova University
name: Zehra Hatipoğlu, Assist Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hatipoglu Z, Gulec E, Turktan M, Izol V, Aridogan A, Gunes Y, Ozcengiz D. Comparative study of ultrasound-guided paravertebral block versus intravenous tramadol for postoperative pain control in percutaneous nephrolithotomy. BMC Anesthesiol. 2018 Feb 17;18(1):24. doi: 10.1186/s12871-018-0479-7.