NCT02412930

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for phase_4 postoperative-pain

Timeline
Completed

Started Mar 2012

Longer than P75 for phase_4 postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 9, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

March 22, 2017

Status Verified

March 1, 2017

Enrollment Period

4 years

First QC Date

March 27, 2015

Last Update Submit

March 21, 2017

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale

    Postoperative pain degree was evaluated by Visual Analogue Scale

    up to 24 hours

Secondary Outcomes (1)

  • tramadol consumption

    up to 24 hours

Study Arms (2)

Group Paravertebral Block

ACTIVE COMPARATOR

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 BlockDrug: Group TramadolDrug: BupivacaineDevice: Ultrasound

Group tramadol

PLACEBO COMPARATOR

Patients in group T were given a loading dose of tramadol of 1 mgkg-1

Drug: Group Tramadol

Interventions

Ultrasound-guided Paravertebral BlockPROCEDURE

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.

Group Paravertebral Block
Group TramadolDRUG

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.

Group Paravertebral BlockGroup tramadol
BupivacaineDRUG
Group Paravertebral Block
UltrasoundDEVICE
Group Paravertebral Block

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients scheduled for percutaneous nephrolithotomy (PNL),
  • years of age,
  • weight between 50-100 kg,
  • American Society of Anesthesiologists (ASA) classification I-II were included

You may not qualify if:

  • coagulation abnormalities,
  • patients with spinal deformity,
  • cutaneous infection at the injection site and
  • a known allergy to drugs.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University Faculty of Medicine

Adana, 01230, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 29454333DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Interventions

BupivacaineUltrasonography

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Zehra Hatipoğlu, Assist Prof

    Cukurova University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

March 27, 2015

First Posted

April 9, 2015

Study Start

March 1, 2012

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

March 22, 2017

Record last verified: 2017-03

Locations

TU(1)