Serratus Anterior Plane Block Versus Intercostal Nerve Block for Postoperative Analgesia

January 29, 2020 updated by: Saeyoung Kim, MD, PhD, Kyungpook National University Hospital

Serratus Anterior Plane Block vs. Intercostal Nerve Block for Postoperative Analgesic Effect After Video-assisted Thoracoscopic Lobectomy: A Randomized Prospective Study

A prospective randomized controlled study was undertaken to compare the postoperative analgesic effect between ultrasound-guided serratus anterior plane block and intercostal nerve block after video-assisted thoracoscopic lobectomy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Post-thoracotomy pain is one of the most notorious postsurgical pains that one can experience. The pain is known to last for an extensive period of time with significantly high intensity.

In field of thoracic surgery, video-assisted thoracoscopic surgery has been played an important role in alleviating the postoperative pain. In field of anesthesiology, various attempts to alleviate post-thoracotomy pain have been tried along advancement of thoracic surgical techniques. It began with postoperative medication of non-steroid anti-inflammatory drugs, opioids and progressed into implementations such as local analgesia, thoracic epidural block, paravertebral block, intercostal nerve block, interpleural block and serratus anterior plane block.

Many analgesic methods have been applied to alleviate postoperative pain in patients who have undergone thoracoscopic surgeries. However, there are no prospective randomized controlled studies between intercostal nerve block and serratus anterior plane block in video-assisted thoracoscopic lobectomy. The main purpose of this study is to compare and analyze the effects between conventional intercostal nerve block and newly introduced serratus anterior plane block in lung cancer patients who have undergone video-assisted thoracoscopic lobectomy.

This prospective study will discover the efficacy and differences between two methods.

Study Type

Interventional

Enrollment (Anticipated)

50

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

  • Korea, Republic of
      • Daegu, Korea, Republic of, 700-412
        • Recruiting
        • Kyungpook National University Hospital

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 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • lung cancer
  • American Society of Anesthesiologists (ASA) I-III class
  • Video-assisted thoracoscopic lobectomy

Exclusion Criteria:

  • previous history of allergy to local anesthetics
  • psychological disorder
  • chronic analgesics or sedatives use
  • coagulopathy
  • The presence of systemic infection or local infection at injection site
  • Pregnancy

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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Serratus Anterior Plane Block
Serratus Anterior Plane Block was performed just before the start of surgery after anesthetic induction through ultrasound-guidance. 20ml of 0.375% ropivacaine was slowly injected between the fascia of serratus anterior and latissimus dorsi near 5th rib.
Procedure: Thoracoscopic lobectomy
Thoracoscopic lobectomy was performed for lung cancer
ACTIVE_COMPARATOR: Intercostal Nerve Block
Intercostal Nerve Block was performed just before closing the surgical incision while looking directly at the affected intercostal space. 10ml of 0.375% ropivacaine was delivered evenly at anterior and posterior intercostal spaces from the port site.
Procedure: Thoracoscopic lobectomy
Thoracoscopic lobectomy was performed for lung cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain: numeric rating scale
Time Frame: at postanesthesia care unit (PACU)
Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable)
at postanesthesia care unit (PACU)
Postoperative pain: numeric rating scale
Time Frame: 3 hours later operation
Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable)
3 hours later operation
Postoperative pain: numeric rating scale
Time Frame: 6 hours later operation
Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable)
6 hours later operation
Postoperative pain: numeric rating scale
Time Frame: 12 hours later operation
Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable)
12 hours later operation
Postoperative pain: numeric rating scale
Time Frame: 24 hours later operation
Postoperative pain will be evaluated using a numeric rating scale (0 being no pain, 10 being worst pain imaginable)
24 hours later operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of analgesics consumption
Time Frame: through study completion, an average of 1 yea
If the participant has additional analgesic requirement postoperatively, ketorolac 30mg will be injected intravenously when numeric rating scale score is measured as 4-5, and fentanyl 50# is injected when numeric rating scale score is over 6.
through study completion, an average of 1 yea
Amount of analgesics consumption
Time Frame: : through study completion, an average of 1 year
If the participant has additional analgesic requirement postoperatively, ketorolac 30mg will be injected intravenously when numeric rating scale score is measured as 4-5, and fentanyl 50# is injected when numeric rating scale score is over 6.
: through study completion, an average of 1 year

Collaborators and Investigators

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

Sponsor

Kyungpook National University 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)

August 16, 2019

Primary Completion (ANTICIPATED)

January 31, 2020

Study Completion (ANTICIPATED)

February 29, 2020

Study Registration Dates

First Submitted

January 29, 2020

First Submitted That Met QC Criteria

January 29, 2020

First Posted (ACTUAL)

January 31, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 31, 2020

Last Update Submitted That Met QC Criteria

January 29, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-07-008-002

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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