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Completed

NCT Number: NCT02507700

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

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.

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Key information

Conditions

Postoperative Pain Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Nervous System Diseases Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

3 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital

Ankara, 06110, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Popliteal block

Procedure

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

Sevoflurane

Drug

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

Ultrasound

Device

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

Plaster cover

Other

Plaster cover will be used to control group for sham procedure

Bupivacaine

Drug

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

Laryngeal mask airway

Other

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

Primary outcomes

  1. Postoperative pain assessment via Wong Baker faces scale

    Time frame: The patients will be followed up to 24 hours

  2. The number of fluctuations of skin conductance per second (NFSC).

    Time frame: The patients will be followed up to 24 hours

Sponsors and collaborators

Lead sponsor

Diskapi Teaching and Research Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 24, 2015
Registry last updated
Jun 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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