The Effects of Serratus Anterior Plane Block on Postoperative Quality of Recovery and Analgesia After Video-assisted Thoracoscopic Surgery
1 other identifier
interventional
90
1 country
1
Brief Summary
Postoperative pain still remains a challenging problem in patients undergoing video-assisted thoracoscopic surgery (VATS). However, there is no gold standard for regional analgesia for VATS. Serratus anterior plane block (SPB) under ultrasound guidance has been described recently to achieve complete paresthesia of the hemithorax. Therefore, SPB has the possibility to provide analgesia following thoracic surgery. Pain following surgery is a critical side effect of surgery, which increases the risk of complications and delays a recovery. Therefore, SPB may help not only reduce pain following VATS, but also increase the quality of recovery. This study aims to investigate the effectiveness of ultrasound-guided SPB on the quality of recovery and pain in patients undergoing VATS.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 28, 2014
CompletedFirst Submitted
Initial submission to the registry
December 4, 2014
CompletedFirst Posted
Study publicly available on registry
December 8, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 28, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
July 28, 2016
CompletedFebruary 18, 2019
February 1, 2019
2.5 years
December 4, 2014
February 14, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Quality of Recovery 40 score
24 hours after operation day
Study Arms (2)
ropivacaine group
EXPERIMENTAL45 patients will be randomly allocated into ropivacaine group with 0.4 ml/kg of 0.375% ropivacaine after induction of anesthesia.
saline group
PLACEBO COMPARATOR40 patients are randomly allocated into saline group with 0.4 ml/kg saline after induction of anesthesia.
Interventions
90 patients are randomly allocated into two groups: ropivacaine group (n=45), saline group (n=40). In the ropivacaine group, ultrasound-guided serratus anterior plane block is performed with 0.4 ml/kg of 0.375% ropivacaine after induction of anesthesia. In the saline group, ultrasound-guided serratus anterior plane block is performed with 0.4 ml/kg saline after induction of anesthesia.
Eligibility Criteria
You may qualify if:
- Adult patients (20-65 years of age) scheduled for elective video-assisted thoracoscopic surgery
- ASA class I and II
You may not qualify if:
- Allergy to local anesthetics or contraindication to use of ropivacaine
- Pregnancy
- Neurologic and psychologic disease
- Severe cardiovascular disease
- Liver failure
- Renal failure
- Chronic treatment with analgesics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Severance Hospital
Seoul, 120-752, South Korea
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 4, 2014
First Posted
December 8, 2014
Study Start
January 28, 2014
Primary Completion
July 28, 2016
Study Completion
July 28, 2016
Last Updated
February 18, 2019
Record last verified: 2019-02