Serratus Anterior Plane Block for Pain Treatment After Video-Assisted Thoracoscopic Surgery

July 13, 2017 updated by: Korgün Ökmen, Bursa Yüksek İhtisas Education and Research Hospital

Evaluation of the Effect of Serratus Anterior Plane Block for Pain Treatment After Video-Assisted Thoracoscopic Surgery

Analgesia following video-assisted thoracoscopic surgery (VATS) is important for the prevention of postoperative pulmonary complications.Various regional methods of anesthesia are currently being used to achieve this goal. The aim of the study was to assess the effectiveness of SAPB on postoperative VATS analgesia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who were in the American Society of Anesthesiologists (ASA) I-III class and underwent video-assisted thoracoscopic surgery (VATS).

Exclusion Criteria:

  • Previous history of opioid use preoperatively,
  • Allergy to local anesthetics,
  • The presence of any systemic infection,
  • Uncontrolled arterial hypertension,
  • Uncontrolled diabetes mellitus.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group S

IV patient-controlled analgesia (PCA) tramadol+Serratus Anterior Plane Block(SAPB) Tramadol infusion (PCA): 400 mg tramadol, IV 4 mg/mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.

20 mL of bupivacaine at a concentration of 0.25% to between serratus anterior and intercostal muscle using the in-line technique for SAPB.
Procedure: Serratus Anterior Plane Block
Drug: IV patient-controlled analgesia (PCA) tramadol
Active Comparator: Group T
IV patient-controlled analgesia (PCA) tramadol Tramadol infusion (PCA): 400 mg tramadol, IV 4 mg/mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.
Drug: IV patient-controlled analgesia (PCA) tramadol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale
Time Frame: Postoperative 24 hours
Visual Analogue Scale was used for pain
Postoperative 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
tramadol consumption
Time Frame: Postoperative 24 hour
tramadol consumption
Postoperative 24 hour
Ramsay sedation scale (RSS)
Time Frame: 24 hours
Ramsay sedation scale (RSS)
24 hours

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
side effect profile
Time Frame: 24 hours
side effect profile
24 hours
additional analgesic use
Time Frame: 24 hours
additional analgesic use
24 hours

Collaborators and Investigators

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

Sponsor

Bursa Yüksek İhtisas Education and Research Hospital

Investigators

  • Principal Investigator: Burcu Metin Ökmen, University of Health Sciences, Bursa Yuksek Ihtisas Training and Research Hospital

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)

July 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

July 2, 2017

First Submitted That Met QC Criteria

July 11, 2017

First Posted (Actual)

July 14, 2017

Study Record Updates

Last Update Posted (Actual)

July 17, 2017

Last Update Submitted That Met QC Criteria

July 13, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-KAEK-25 2016/13-06

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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