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

Not Applicable

Completed

• Conditions: Postoperative Pain; Cerebral Palsy
• Interventions: Drug: Sevoflurane; Procedure: Popliteal block; Other: Plaster cover; Device: Ultrasound; Drug: bupivacaine; Other: Laryngeal mask airway

• Registration Number: NCT02507700
• Lead Sponsor: Diskapi Teaching and Research Hospital

Brief Summary

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

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 Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-07-15
• Study First Submitted QC: 2015-07-23
• Study First Posted: 2015-07-24
• Primary Completion: 2016-05
• Status Verified: 2016-06
• Study Completion: 2016-06
• Last Update Submitted: 2016-06-10
• Last Update Posted: 2016-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
popliteal block	Laryngeal mask airway	Popliteal block will be performed with a single dose of 0.3 ml·kg(-1) of 0.25% bupivacaine.
Plaster cover	Sevoflurane	Only plaster cover will be applied without nerve block for sham procedure.
Plaster cover	Plaster cover	Only plaster cover will be applied without nerve block for sham procedure.
Plaster cover	Laryngeal mask airway	Only plaster cover will be applied without nerve block for sham procedure.
popliteal block	Popliteal block	Popliteal block will be performed with a single dose of 0.3 ml·kg(-1) of 0.25% bupivacaine.
popliteal block	Sevoflurane	Popliteal block will be performed with a single dose of 0.3 ml·kg(-1) of 0.25% bupivacaine.
popliteal block	Ultrasound	Popliteal block will be performed with a single dose of 0.3 ml·kg(-1) of 0.25% bupivacaine.
popliteal block	bupivacaine	Popliteal block will be performed with a single dose of 0.3 ml·kg(-1) of 0.25% bupivacaine.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital; 🇹🇷 Ankara, Turkey