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

NCT ID: NCT02507700

Last Updated: 2016-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Study Completion Date

2016-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Postoperative Pain Cerebral Palsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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popliteal block

Popliteal block will be performed with a single dose of 0.3 ml·kg(-1) of 0.25% bupivacaine.

Group Type ACTIVE_COMPARATOR

Popliteal block

Intervention Type PROCEDURE

In group P, popliteal block will be performed with ultrasound guidence.

Sevoflurane

Intervention Type DRUG

Sevoflurane will be used to all patient's for anesthesia induction and maintenance

Ultrasound

Intervention Type DEVICE

For recognize the nerve (sciatic nerve), ultrasound will be used in group P.

bupivacaine

Intervention Type DRUG

Bupivacaine 0.25% will be performed for popliteal block to group P.

Laryngeal mask airway

Intervention Type OTHER

After anesthesia induction, laryngeal mask airway will be inserted to all patients

Plaster cover

Only plaster cover will be applied without nerve block for sham procedure.

Group Type SHAM_COMPARATOR

Sevoflurane

Intervention Type DRUG

Sevoflurane will be used to all patient's for anesthesia induction and maintenance

Plaster cover

Intervention Type OTHER

Plaster cover will be used to control group for sham procedure

Laryngeal mask airway

Intervention Type OTHER

After anesthesia induction, laryngeal mask airway will be inserted to all patients

Interventions

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Popliteal block

In group P, popliteal block will be performed with ultrasound guidence.

Intervention Type PROCEDURE

Sevoflurane

Sevoflurane will be used to all patient's for anesthesia induction and maintenance

Intervention Type DRUG

Ultrasound

For recognize the nerve (sciatic nerve), ultrasound will be used in group P.

Intervention Type DEVICE

Plaster cover

Plaster cover will be used to control group for sham procedure

Intervention Type OTHER

bupivacaine

Bupivacaine 0.25% will be performed for popliteal block to group P.

Intervention Type DRUG

Laryngeal mask airway

After anesthesia induction, laryngeal mask airway will be inserted to all patients

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diskapi Teaching and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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derya özkan

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Taylan Akkaya

Role: STUDY_CHAIR

Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital

Mesut Bakır

Role: STUDY_CHAIR

Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital

Locations

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Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Ledowski T, Bromilow J, Wu J, Paech MJ, Storm H, Schug SA. The assessment of postoperative pain by monitoring skin conductance: results of a prospective study. Anaesthesia. 2007 Oct;62(10):989-93. doi: 10.1111/j.1365-2044.2007.05191.x.

Reference Type RESULT
PMID: 17845649 (View on PubMed)

Johnston BM, Gunn TR, Gluckman PD. Surface cooling rapidly induces coordinated activity in the upper and lower airway muscles of the fetal lamb in utero. Pediatr Res. 1988 Mar;23(3):257-61. doi: 10.1203/00006450-198803000-00005.

Reference Type RESULT
PMID: 3353170 (View on PubMed)

Ozkan D, Gonen E, Akkaya T, Bakir M. Popliteal block for lower limb surgery in children with cerebral palsy: effect on sevoflurane consumption and postoperative pain (a randomized, double-blinded, controlled trial). J Anesth. 2017 Jun;31(3):358-364. doi: 10.1007/s00540-017-2318-2. Epub 2017 Feb 14.

Reference Type DERIVED
PMID: 28197774 (View on PubMed)

Other Identifiers

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DiskapiTRH 2015

Identifier Type: -

Identifier Source: org_study_id

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