Clinical trial NCT05008614: Comparison of Continuous ESP Versus TEA After Thoracotomy
Official title: Continuous Erector Spinae Plane Block Versus Thoracic Epidural Analgesia After Thoracotomy: A Randomized Controlled Assessor-blinded Non-inferiority Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Pain
Keywords: thoracotomy
lung cancer
interfascial plane block
nerve block
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Seoul National University
First posted: 2021-08-17
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective randomized controlled assessor-blinded non-inferiority trial
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Maximum postoperative pain score at rest on postoperative day 1
timeFrame: Maximum pain score among the 9 am and 4 pm measurements on postoperative day 1
Secondary outcomes:
measure: Postoperative pain score at rest
timeFrame: 9am/4pm on postoperative day 1, 9am/4pm on postoperative day 2, 9am/4pm on postoperative day 3
measure: Postoperative pain score at movement
timeFrame: 9am/4pm on postoperative day 1, 9am/4pm on postoperative day 2, 9am/4pm on postoperative day 3
measure: Change in the total consumption (ml) of patient-controlled analgesia
timeFrame: 9am/4pm on postoperative day 1, 9am/4pm on postoperative day 2, 9am/4pm on postoperative day 3
measure: Change in the quality of recovery-15 scale from baseline to postoperative day 3
timeFrame: Day before surgery and 4pm on postoperative day 3
measure: Postoperative pulmonary function test
timeFrame: 3 months after surgery
measure: Incidence of chronic postoperative pain
timeFrame: 3 months after surgery
measure: Incidence of chronic postoperative pain
timeFrame: 6 months after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: