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

Primary Purpose

Postoperative Pain, Cerebral Palsy

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Popliteal block
Sevoflurane
Ultrasound
Plaster cover
bupivacaine
Laryngeal mask airway
Sponsored by
Diskapi Teaching and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring nerve block

Eligibility Criteria

3 Years - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

popliteal block

Plaster cover

Arm Description

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

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

Outcomes

Primary Outcome Measures

Postoperative pain assessment via Wong Baker faces scale
The number of fluctuations of skin conductance per second (NFSC).

Secondary Outcome Measures

Full Information

First Posted
July 15, 2015
Last Updated
June 10, 2016
Sponsor
Diskapi Teaching and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02507700
Brief Title
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

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Teaching and Research Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Cerebral Palsy
Keywords
nerve block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
popliteal block
Arm Type
Active Comparator
Arm Description
Popliteal block will be performed with a single dose of 0.3 ml·kg(-1) of 0.25% bupivacaine.
Arm Title
Plaster cover
Arm Type
Sham Comparator
Arm Description
Only plaster cover will be applied without nerve block for sham procedure.
Intervention Type
Procedure
Intervention Name(s)
Popliteal block
Intervention Description
In group P, popliteal block will be performed with ultrasound guidence.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
Sevoflurane will be used to all patient's for anesthesia induction and maintenance
Intervention Type
Device
Intervention Name(s)
Ultrasound
Intervention Description
For recognize the nerve (sciatic nerve), ultrasound will be used in group P.
Intervention Type
Other
Intervention Name(s)
Plaster cover
Intervention Description
Plaster cover will be used to control group for sham procedure
Intervention Type
Drug
Intervention Name(s)
bupivacaine
Intervention Description
Bupivacaine 0.25% will be performed for popliteal block to group P.
Intervention Type
Other
Intervention Name(s)
Laryngeal mask airway
Intervention Description
After anesthesia induction, laryngeal mask airway will be inserted to all patients
Primary Outcome Measure Information:
Title
Postoperative pain assessment via Wong Baker faces scale
Time Frame
The patients will be followed up to 24 hours
Title
The number of fluctuations of skin conductance per second (NFSC).
Time Frame
The patients will be followed up to 24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Taylan Akkaya
Organizational Affiliation
Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Mesut Bakır
Organizational Affiliation
Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Ministry of Health Diskapi Yıldırım Beyazıt Training and Research Hospital
City
Ankara
ZIP/Postal Code
06110
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
17845649
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.
Results Reference
result
PubMed Identifier
3353170
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.
Results Reference
result
PubMed Identifier
28197774
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.
Results Reference
derived

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

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