The Effects of Serratus Anterior Plane Block on Postoperative Quality of Recovery and Analgesia After Video-assisted Thoracoscopic Surgery

NCT ID: NCT02311517

Last Updated: 2019-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-28

Study Completion Date

2016-07-28

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Quality of Recovery and Analgesia After Video-assisted Thoracoscopic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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ropivacaine group

45 patients will be randomly allocated into ropivacaine group with 0.4 ml/kg of 0.375% ropivacaine after induction of anesthesia.

Group Type EXPERIMENTAL

Ropivacaine

Intervention Type DRUG

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.

saline group

40 patients are randomly allocated into saline group with 0.4 ml/kg saline after induction of anesthesia.

Group Type PLACEBO_COMPARATOR

Normal Saline

Intervention Type DRUG

Interventions

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Ropivacaine

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.

Intervention Type DRUG

Normal Saline

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Adult patients (20-65 years of age) scheduled for elective video-assisted thoracoscopic surgery
2. ASA class I and II

Exclusion Criteria

1. Allergy to local anesthetics or contraindication to use of ropivacaine
2. Pregnancy
3. Neurologic and psychologic disease
4. Severe cardiovascular disease
5. Liver failure
6. Renal failure
7. Chronic treatment with analgesics
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Severance Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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4-2014-0853

Identifier Type: -

Identifier Source: org_study_id

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