Clinical trial NCT02507700: Popliteal Block for Postoperative Pain in Knee-ankle Soft Tissue Surgery in Cerebral Palsy
Official title: Popliteal Block for Postoperative Pain in Knee-ankle Soft Tissue Surgery in Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Cerebral Palsy
Keywords: nerve block
Lead sponsor: Diskapi Teaching and Research Hospital
Sponsor class: OTHER
First posted: 2015-07-24
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative pain assessment via Wong Baker faces scale
timeFrame: The patients will be followed up to 24 hours
measure: The number of fluctuations of skin conductance per second (NFSC).
timeFrame: The patients will be followed up to 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital
Study officials:
affiliation: Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital
name: Taylan Akkaya
role: STUDY_CHAIR
affiliation: Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital
name: Mesut Bakır
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.