Comparison of Continuous ESP Versus TEA After Thoracotomy

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

COMPLETED

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-22

Study Completion Date

2024-12-31

Brief Summary

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This prospective, randomized, assessor-blinded study is designed to evaluate the postoperative analgesic efficacy of the ultrasound-guided continuous erector spinae plane (ESP) block in patients undergoing thoracotomy. We hypothesize that US-guided ESP block is not inferior to thoracic epidural analgesia in terms of postoperative pain control in these patients.

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Detailed Description

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Adult patients undergoing elective unilateral thoracotomy for lung cancer resection are randomly allocated to receive US-guided ESP block (n=31) or thoracic epidural analgesia (n=31). Both procedures are performed prior to surgery. Each patient was assessed by a blinded investigator on postoperative day (POD) 1,2 and 3. The primary outcome is pain severity evaluated by a numeric rating scale (NRS) at POD1.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A prospective randomized controlled assessor-blinded non-inferiority trial

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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Study Groups

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Erector spinae plane block group (ESP group)

Patients receiving continuous unilateral ESP block.

Interventions:

Procedure: Ultrasound-guided unilateral ESP block via catheter placement for continuous infusion Drug: Ropivacaine 0.75% Injectable Solution Device: 21-gauge 85 mm perineural catheter, 18-gauge 100 mm stimulator needle (Silverstim, Vygon, Ecouen, France)

Group Type EXPERIMENTAL

Erector spinae plane block group

Intervention Type PROCEDURE

Before surgery, an anesthesiologist will perform unilateral ESP block with catheterization under ultrasound guidance in the procedure room.

Drug: Ropivacaine 0.75% Injectable Solution 0.2% ropivacaine is continuously infused to the erector spinae plane at T5 level via 18G 85 mm perineural catheter (Silverstim, Vygon, Ecouen, France) (basal infusion: 10ml/hr, bolus 5ml, lockout time: 20min)

Thoracic epidural analgesia group (TEA group)

Patients receiving thoracic epidural analgesia.

Interventions:

Procedure: Fluoroscopy-guided thoracic epidural analgesia Drug: Ropivacaine 0.75% Injectable Solution Device: 17-gauge Tuohy needle (FlexTip Plus®, Teleflex Medical, USA)

Group Type ACTIVE_COMPARATOR

Thoracic epidural analgesia group

Intervention Type PROCEDURE

Before surgery, an anesthesiologist will perform unilateral ESP block with catheterization under fluoroscopy guidance in the procedure room.

Drug: Ropivacaine 0.75% Injectable Solution 0.2% ropivacaine is continuously infused to the erector spinae plane at T5 level via 17-gauge catheter (FlexTip Plus®, Teleflex Medical, USA) (Silverstim, Vygon, Ecouen, France) (basal infusion: 3ml/hr, bolus 1ml, lockout time: 20min)

Interventions

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Erector spinae plane block group

Before surgery, an anesthesiologist will perform unilateral ESP block with catheterization under ultrasound guidance in the procedure room.

Drug: Ropivacaine 0.75% Injectable Solution 0.2% ropivacaine is continuously infused to the erector spinae plane at T5 level via 18G 85 mm perineural catheter (Silverstim, Vygon, Ecouen, France) (basal infusion: 10ml/hr, bolus 5ml, lockout time: 20min)

Intervention Type PROCEDURE

Thoracic epidural analgesia group

Before surgery, an anesthesiologist will perform unilateral ESP block with catheterization under fluoroscopy guidance in the procedure room.

Drug: Ropivacaine 0.75% Injectable Solution 0.2% ropivacaine is continuously infused to the erector spinae plane at T5 level via 17-gauge catheter (FlexTip Plus®, Teleflex Medical, USA) (Silverstim, Vygon, Ecouen, France) (basal infusion: 3ml/hr, bolus 1ml, lockout time: 20min)

Intervention Type PROCEDURE

Other Intervention Names

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ESP group TEA group

Eligibility Criteria

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Inclusion Criteria

* Patients scheduled to undergo elective thoracotomy for lung cancer
* European Cooperative Oncology Group 0 or 1
* American Society of Anesthesiologists (ASA) physical classification I-III
* Willingness and ability to sign an informed consent document

Exclusion Criteria

* patients with chronic postoperative pain after thoracic surgery
* patients undergoing thoracotomy with chest wall resection
* allergies to anesthetic or analgesic medications
* patients with coagulopathy or who continue to take anticoagulants
* preoperative liver or renal dysfunction
* patients with chronic pain, chronic opioid, analgesic or antidepressant or anticonvulsant use
* Do not understand our study
* Medical or psychological disease that can affect the treatment response

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No