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

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

Tracking Information
First Submitted Date  ICMJE March 27, 2015
First Posted Date  ICMJE April 9, 2015
Last Update Posted Date March 22, 2017
Actual Study Start Date  ICMJE March 2012
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2017)
Visual Analogue Scale [ Time Frame: up to 24 hours ]
Postoperative pain degree was evaluated by Visual Analogue Scale
Original Primary Outcome Measures  ICMJE
 (submitted: April 8, 2015)
Visual Analogue Scale [ Time Frame: up to 24 hours ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2017)
tramadol consumption [ Time Frame: up to 24 hours ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Study of Ultrasound-guided Paravertebral Block Versus Intravenous Tramadol in Percutaneous Nephrolithotomy
Official Title  ICMJE Comparative Study of Ultrasound-guided Paravertebral Block Versus Intravenous Tramadol for Postoperative Pain Control in Percutaneous Nephrolithotomy
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Postoperative Pain
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Procedure: Ultrasound-guided Paravertebral Block
    • Drug: Group Tramadol
    • Drug: Bupivacaine
    • Device: Ultrasound
  • Placebo Comparator: Group tramadol
    Patients in group T were given a loading dose of tramadol of 1 mgkg-1
    Intervention: Drug: Group Tramadol
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 21, 2017)
53
Original Estimated Enrollment  ICMJE
 (submitted: April 8, 2015)
60
Actual Study Completion Date  ICMJE April 2016
Actual Primary Completion Date March 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02412930
Other Study ID Numbers  ICMJE 5/8-2012
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zehra, Cukurova University
Study Sponsor  ICMJE Cukurova University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Zehra Hatipoğlu, Assist Prof Cukurova University
PRS Account Cukurova University
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP