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

February 14, 2019 updated by: Yonsei University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ropivacaine group
45 patients will be randomly allocated into ropivacaine group with 0.4 ml/kg of 0.375% ropivacaine after induction of anesthesia.
Drug: 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.
Placebo Comparator: saline group
40 patients are randomly allocated into saline group with 0.4 ml/kg saline after induction of anesthesia.
Drug: Normal Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of Recovery 40 score
Time Frame: 24 hours after operation day
24 hours after operation day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 28, 2014

Primary Completion (Actual)

July 28, 2016

Study Completion (Actual)

July 28, 2016

Study Registration Dates

First Submitted

December 4, 2014

First Submitted That Met QC Criteria

December 4, 2014

First Posted (Estimate)

December 8, 2014

Study Record Updates

Last Update Posted (Actual)

February 18, 2019

Last Update Submitted That Met QC Criteria

February 14, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2014-0853

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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