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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02507700
• Other study ID #: DiskapiTRH 2015
• Status: Completed
• Phase: N/A
• First received: July 15, 2015
• Last updated: June 10, 2016
• Start date: June 2015
• Est. completion date: June 2016

Study information

• Verified date: June 2016
• Source: Diskapi Teaching and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years to 15 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy
• Pain, Postoperative
• Postoperative Pain

Intervention

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.

Other:
• Plaster cover
Plaster cover will be used to control group for sham procedure

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

Locations

Country	Name	City	State
Turkey	Ministry of Health Diskapi Yildirim Beyazit Training and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Diskapi Teaching and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain assessment via Wong Baker faces scale		The patients will be followed up to 24 hours	Yes
Primary	The number of fluctuations of skin conductance per second (NFSC).		The patients will be followed up to 24 hours	Yes