Postoperative Pain
Conditions
Keywords
thoracotomy, lung cancer, interfascial plane block, nerve block
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.
Interventions
PROCEDUREErector 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)
PROCEDUREThoracic 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)
Sponsors
Seoul National University
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcome assessor not involved in this study will investigate the outcomes.
Intervention model description
A prospective randomized controlled assessor-blinded non-inferiority trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum postoperative pain score at rest on postoperative day 1 | Maximum pain score among the 9 am and 4 pm measurements on postoperative day 1 | pain score measured by the 11-pointed numeric rating scale (0: none/10: worst pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain score at movement | 9am/4pm on postoperative day 1, 9am/4pm on postoperative day 2, 9am/4pm on postoperative day 3 | Change in the pain score at movement measured by the 11-pointed numeric rating scale (0: none/10: worst pain) from postoperative day 1 to postoperative day 3 |
| Change in the total consumption (ml) of patient-controlled analgesia | 9am/4pm on postoperative day 1, 9am/4pm on postoperative day 2, 9am/4pm on postoperative day 3 | total consumption (ml) of epidural or erector spinae plane patient-controlled analgesia |
| Postoperative pain score at rest | 9am/4pm on postoperative day 1, 9am/4pm on postoperative day 2, 9am/4pm on postoperative day 3 | Change in the pain score at rest measured by the 11-pointed numeric rating scale (0: none/10: worst pain) from postoperative day 1 to postoperative day 3 |
| Postoperative pulmonary function test | 3 months after surgery | measured at outpatient clinic |
| Incidence of chronic postoperative pain | 3 months after surgery | measure by the Korean version of the pain DETECT |
| Change in the quality of recovery-15 scale from baseline to postoperative day 3 | Day before surgery and 4pm on postoperative day 3 | measured by the Korean version of the quality of recovery-15 |
Countries
South Korea
Outcome results
None listed