Ultrasound-Guided Serratus Anterior Plane Block in Pneumothorax Surgery

NCT ID: NCT04191850

Last Updated: 2019-12-10

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-01

Study Completion Date

2020-01-31

Brief Summary

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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 single port video-assisted thoracoscopic surgery with primary spontaneous pneumothorax.

Detailed Description

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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. Furthermore, single-port thoracoscopic surgery, which reduces the number of surgical incision, is increasingly carried out by many institutions world widely.

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 single port video-assisted thoracoscopic surgeries. 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 primary spontaneous pneumothorax patients who have undergone single port video-assisted thoracoscopic wedge resection. This prospective study will discover the efficacy and differences between two methods.

Conditions

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Analgesia Postoperative Pain Pneumothorax

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Single Port Video-Assisted Thoracoscopic Surgery

Intervention Type PROCEDURE

Single Port Video-Assisted Thoracoscopic wedge resection was performed for primary spontaneous pneumothorax.

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.

Group Type EXPERIMENTAL

Single Port Video-Assisted Thoracoscopic Surgery

Intervention Type PROCEDURE

Single Port Video-Assisted Thoracoscopic wedge resection was performed for primary spontaneous pneumothorax.

Interventions

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Single Port Video-Assisted Thoracoscopic Surgery

Single Port Video-Assisted Thoracoscopic wedge resection was performed for primary spontaneous pneumothorax.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. American Society of Anesthesiologists (ASA) physical status 1 or 2
2. primary spontaneous pneumothorax
3. elective single port video-assisted thoracoscopic wedge resection of the lung.

Exclusion Criteria

1. secondary spontaneous pneumothorax
2. reoperation in ipsilateral thorax
3. a history of drug allergy for analgesics
4. participants who have difficulty understanding the study protocol
5. refusal of participants
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyungpook National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Saeyoung Kim, MD, PhD

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Saeyoung Saeyoung

Role: PRINCIPAL_INVESTIGATOR

Kyungpook National University Hospital

Locations

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Kyungpook national university hospital

Daegu, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Jimin Heo

Role: CONTACT

Phone: +82-53-420-5430

Email: [email protected]

Saeyoung Saeyoung

Role: CONTACT

Phone: +82-53-420-5873

Email: [email protected]

Facility Contacts

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Jimin Heo

Role: primary

Other Identifiers

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2017-12-012-001

Identifier Type: -

Identifier Source: org_study_id