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

NCT02507700 | Completed

• 1 other identifier: DiskapiTRH 2015
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Pain; Cerebral Palsy

Keywords

nerve block

Outcome Measures

Primary Outcomes (2)

• Postoperative pain assessment via Wong Baker faces scale

  The patients will be followed up to 24 hours

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

  The patients will be followed up to 24 hours

Study Arms (2)

popliteal block

ACTIVE COMPARATOR

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

Procedure: Popliteal block; Drug: Sevoflurane; Device: Ultrasound; Drug: bupivacaine; Other: Laryngeal mask airway

Plaster cover

SHAM COMPARATOR

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

Drug: Sevoflurane; Other: Plaster cover; Other: Laryngeal mask airway

Interventions

Popliteal block PROCEDURE

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

popliteal block

Sevoflurane DRUG

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

Plaster cover; popliteal block

Ultrasound DEVICE

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

popliteal block

Plaster cover OTHER

Plaster cover will be used to control group for sham procedure

Plaster cover

bupivacaine DRUG

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

popliteal block

Laryngeal mask airway OTHER

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

Plaster cover; popliteal block

Eligibility Criteria

• Age: 3 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with cerebral palsy
• Scheduled for knee and ankle surgery

You may not qualify if:

• Autonomic neuropathy
• Medication with anticholinergic drugs
• Continuous infusion of vasoactive drugs

Sponsors & Collaborators

• Diskapi Teaching and Research Hospital: lead

Study Sites (1)

Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital

Ankara, 06110, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 17845649 RESULT

• 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.

  PMID: 3353170 RESULT

• 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.

  PMID: 28197774 DERIVED

MeSH Terms

Conditions

Pain, Postoperative; Cerebral Palsy

Interventions

Sevoflurane; Ultrasonography; Bupivacaine; Laryngeal Masks

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Methyl Ethers; Ethers; Organic Chemicals; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Anilides; Amides; Aniline Compounds; Amines; Intubation, Intratracheal; Airway Management; Therapeutics; Intubation; Investigative Techniques; Masks; Protective Devices; Equipment and Supplies; Personal Protective Equipment; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Taylan Akkaya

  Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital

  STUDY CHAIR

• Mesut Bakır

  Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 15, 2015
• First Posted: July 24, 2015
• Study Start: June 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 13, 2016

Record last verified: 2016-06

Locations

TU (1)