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

• ClinicalTrials.gov Identifier: NCT02412930
• Recruitment Status: Completed
• First Posted: April 9, 2015
• Last Update Posted: March 22, 2017
• Sponsor: Cukurova University
• Information provided by (Responsible Party): Zehra, Cukurova University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Postoperative Pain	Procedure: Ultrasound-guided Paravertebral Block; Drug: Group Tramadol; Drug: Bupivacaine; Device: Ultrasound	Phase 4

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 (Clinical Trial)
• Actual Enrollment: 53 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparative Study of Ultrasound-guided Paravertebral Block Versus Intravenous Tramadol for Postoperative Pain Control in Percutaneous Nephrolithotomy
• Actual Study Start Date: March 2012
• Actual Primary Completion Date: March 2016
• Actual Study Completion Date: April 2016

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 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.	Procedure: Ultrasound-guided Paravertebral Block; 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.; Drug: Group Tramadol; 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.; Drug: Bupivacaine; Device: Ultrasound
Placebo Comparator: Group tramadol; Patients in group T were given a loading dose of tramadol of 1 mgkg-1	Drug: Group Tramadol; 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.

Outcome Measures

Primary Outcome Measures :

1. Visual Analogue Scale [ Time Frame: up to 24 hours ]
   Postoperative pain degree was evaluated by Visual Analogue Scale

Secondary Outcome Measures :

1. tramadol consumption [ Time Frame: up to 24 hours ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Turkey

Cukurova University Faculty of Medicine

Adana, Turkey, 01230

Sponsors and Collaborators

Cukurova University

Investigators

• Principal Investigator: Zehra Hatipoğlu, Assist Prof; Cukurova University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Hatipoglu Z, Gulec E, Turktan M, Izol V, Arıdogan 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.

• Responsible Party: Zehra, Assistant professor, Cukurova University
• ClinicalTrials.gov Identifier: NCT02412930
• Other Study ID Numbers: 5/8-2012
• First Posted: April 9, 2015
• Last Update Posted: March 22, 2017
• Last Verified: March 2017

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Tramadol; Bupivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Analgesics, Opioid; Narcotics; Analgesics