The Effect of Ultrasound-guided Erector Spinae Block and Intraoperative Intercostal Nerve Block on Postoperative Analgesia in Thoracic Surgery

NCT04581616 | Completed

• 1 other identifier: 202008040RINC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the effect of ultrasound-guided erector spinae plane block and interthoracic intercostal nerve block in thoracic surgery. Interthoracic intercostal nerve block is a routine procedure during the surgery by the surgeon in our hospital, and ultrasound-guide erector spinae plane block is a relative new developed regional analgesia technique introduced since 2016 and mainly done by anesthesiologists. Both technique provide analgesic effect to some extent and reduce opiate consumption and side effects. However, no previous literature or research compare the effect of these two technique in thoracic surgery. The primary endpoint of our study is compare morphine consumption and pain score between patients undergo ESP block and patients undergo ICNB after thoracic surgery; the second endpoint is to compare the recovery condition evaluated by QoR-15 questionaire 24 hours after surgery.

Conditions

Ultrasound Therapy; Complications; Anesthesia; Postoperative Pain

Keywords

Erector Spinae Plane Block, ESPB; Intercostal Nerve Block, ICNB; Thoracic surgery; Postoperative pain; Quality of recovery

Outcome Measures

Primary Outcomes (2)

• Pain intensity

  Pain intensities in two category, namely static and dynamic, gauged by a 0-100 mm visual analogue scale, (no pain to severe pain)

  Postoperative 48 hours

• Postoperative analgesic consumption

  Cumulative morphine consumption in postoperative two days

  Postoperative 48 hours

Secondary Outcomes (1)

• Recovery quality: questionnaire

  Postoperative 24 hours

Study Arms (2)

ICNB group

ACTIVE COMPARATOR

After patient was turned to lateral decubitus position, local anesthetics is injected around incision site and ICNB is performed once after surgeon geys into chest cavity.

Procedure: Intrathoracic Intercostal Nerve Block

ESPB group

EXPERIMENTAL

After patient was turned to lateral decubitus position, ESPB is performed via ultrasound guided technique before sound incision.

Procedure: Erector Spinae Plane Block

Interventions

Intrathoracic Intercostal Nerve Block PROCEDURE

Injection of local anesthetic into the subcostal groove, to achieve analgesia for chest region.

Also known as: ICNB

ICNB group

Erector Spinae Plane Block PROCEDURE

Injection of local anesthetic in the plane deep to the erector spinae muscles and superficial to the transverse processes, to achieve analgesia for chest region.

Also known as: ESPB

ESPB group

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient receive thoracic surgery
• BMI between 18.5\~30.0 kg.m-2

You may not qualify if:

• Pregnant woman
• Patient with any one of following chronic organ dysfunction: Heart failure (NYHA score =III、IV); Renal failure (eGFR\< 60 ml.min-1.1.73m-2)
• Arrhythmia
• Ongoing infection or septic patient
• Chronic use of analgesic with addiction
• Coagulopathy that is not suitable for regional anesthesia performance
• Thoracic surgery that is not suitable for placement of endotracheal blocker tube
• Redo surgery

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• Taipei Veterans General Hospital, Taiwan: collaborator

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 9, 2020
• Study Start: October 16, 2020
• Primary Completion: October 16, 2022
• Study Completion: October 16, 2022
• Last Updated: May 6, 2023

Record last verified: 2020-10

Locations

TW (1)