Popliteal Block for Postoperative Pain in Knee-ankle Soft Tissue Surgery in Cerebral Palsy

June 10, 2016 updated by: derya özkan, Diskapi Teaching and Research Hospital
Popliteal block is a technique for providing postoperative pain management in children. In this randomized double-blinded study, the investigators evaluated the effects of preoperative popliteal nerve block on postoperative pain and analgesic requirement in children with cerebral palsy (CP) undergoing knee-anckle soft tissue surgery. The Wong Baker faces scale and skin conductance fluctuations will be assessed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Sevoflurane will be used for anesthesia induction and maintance. Laryngeal mask airway will be placed without neuromuscular blocking agent. In group P (popliteal block), a single dose of 0.3ml.kg(-1) of 0.25% bupivacaine will be performed for popiteal nerve block (with ultrasound guidence). In group C ( control), only plaster cover will be applied without nerve block for sham procedure to provide double-blinded study. Intraoperative heart rate, mean arterial pressure, BIS (bispectral index) values, sevoflurane consumption will be recorded ten minutes interval. Wong Baker faces scale and skin conductance fluctuations will be recorded at postoperative 0, 10th min, 20th min , 1st h, 4th h, 12th h qnd 24th h. Total analgesic consumption (paracetamol orally ) will be recorded.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06110
        • Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children with cerebral palsy
  • Scheduled for knee and ankle surgery

Exclusion Criteria:

  • Autonomic neuropathy
  • Medication with anticholinergic drugs
  • Continuous infusion of vasoactive drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: popliteal block
Popliteal block will be performed with a single dose of 0.3 ml·kg(-1) of 0.25% bupivacaine.
Procedure: Popliteal block
In group P, popliteal block will be performed with ultrasound guidence.
Drug: Sevoflurane
Sevoflurane will be used to all patient's for anesthesia induction and maintenance
Device: Ultrasound
For recognize the nerve (sciatic nerve), ultrasound will be used in group P.
Drug: bupivacaine
Bupivacaine 0.25% will be performed for popliteal block to group P.
Other: Laryngeal mask airway
After anesthesia induction, laryngeal mask airway will be inserted to all patients
Sham Comparator: Plaster cover
Only plaster cover will be applied without nerve block for sham procedure.
Drug: Sevoflurane
Sevoflurane will be used to all patient's for anesthesia induction and maintenance
Other: Laryngeal mask airway
After anesthesia induction, laryngeal mask airway will be inserted to all patients
Other: Plaster cover
Plaster cover will be used to control group for sham procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative pain assessment via Wong Baker faces scale
Time Frame: The patients will be followed up to 24 hours
The patients will be followed up to 24 hours
The number of fluctuations of skin conductance per second (NFSC).
Time Frame: The patients will be followed up to 24 hours
The patients will be followed up to 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diskapi Teaching and Research Hospital

Investigators

  • Study Chair: Taylan Akkaya, Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital
  • Study Chair: Mesut Bakır, Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

July 15, 2015

First Submitted That Met QC Criteria

July 23, 2015

First Posted (Estimate)

July 24, 2015

Study Record Updates

Last Update Posted (Estimate)

June 13, 2016

Last Update Submitted That Met QC Criteria

June 10, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DiskapiTRH 2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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