Ultrasound-guided Block for Thoracic Surgery Pain

February 26, 2018 updated by: Samsung Medical Center

Ultrasound-guided Serratus Anterior Plane Block for Thoracic Surgery Pain?

The investigators aimed to assess Ultrasounde- guided serratus anterior plane block can be effective in acute postoperative pain following thoracic surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Analgesic options for thoracotomy are various with each having their own merits and demerits.Thoracic epidural is said to be the gold standard for management of thoracotomy pain. However, it is invasive procedure and many side effects. Other options include paravertebral block, interpleural block, intrathecal opioids. Especially, paravertebral block is thought good alternative to epidural anethesia. Most of these invasive neuraxial techniques demand normal coagulation parameters to be present.

The serratus anterior plane block(SAPB) was done under ultrasound guidance in the mid-axillary line at the level of the fourth rib and the catheter was placed superficial to the serratus plane. The patient expressed relief in pain within 10 minutes of being given the bolus of local anaesthetic.Pain following thoracotomy is chiefly due to rib retraction, and damage to the serratus/intercostal muscles and intercostal nerves. A SAPB addresses both these aspects. SAPB has been mentioned in previous studies for management of rib fractures and breast surgeries. The investigators try to evaluate whether the SAPB is easy to perform and provides effective analgesia in patients undergoing thoracotomy with minimal side effects.

Study Type

Interventional

Enrollment (Actual)

89

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

•undergoing thoracic surgery (lobectomy or segmentectomy)

Exclusion Criteria:

• allergy to any drugs chronic pain disease with medication psychologic disorder anti-depressant drug chronic kidney disease ( Cr over 2.0 mg/dl) coagulopathy

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: IV-PCA group
no block performing, only use intravenous patient controled analgesia(IV-PCA)
Drug: patient controlled analgesia
two groups have same intravenous patient controlled analgesia
Experimental: SAPB group
serratus anterior plane block(SAPB) and intravenous patient controled analgesia(IV-PCA)
Drug: patient controlled analgesia
two groups have same intravenous patient controlled analgesia
Procedure: serratus anterior plane block
before surgery :ultrasound-guided serratus anterior plane block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
opioid consumption
Time Frame: the first 24hour in postoperative phase
the dose of PCA and residual opioid
the first 24hour in postoperative phase

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain scale
Time Frame: intraoperative(immediately after surgery), postoperative 6 ,12, 24 hour
numeric rating scale
intraoperative(immediately after surgery), postoperative 6 ,12, 24 hour
opioid consumption
Time Frame: the first 6,12 hour in postoperative phase
the dose of PCA and residual opioid
the first 6,12 hour in postoperative phase

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
questionnaire about patient's satisfaction for pain management
Time Frame: postoperative 24 hour
score 1(bad)-5(good)
postoperative 24 hour

Collaborators and Investigators

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

Sponsor

Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

August 3, 2017

Primary Completion (Actual)

November 30, 2017

Study Completion (Actual)

December 30, 2017

Study Registration Dates

First Submitted

July 28, 2017

First Submitted That Met QC Criteria

August 1, 2017

First Posted (Actual)

August 7, 2017

Study Record Updates

Last Update Posted (Actual)

February 28, 2018

Last Update Submitted That Met QC Criteria

February 26, 2018

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC2017-06-123

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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