Skip to main content
Clinical Trials/NCT04581616
NCT04581616
Completed
Not Applicable

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

National Taiwan University Hospital1 site in 1 country100 target enrollmentOctober 16, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Anesthesia
Sponsor
National Taiwan University Hospital
Enrollment
100
Locations
1
Primary Endpoint
Postoperative analgesic consumption
Status
Completed
Last Updated
2 years ago

Overview

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.

Detailed Description

Sample size estimation is based on our APS team data, in which the average cumulative morphine consumption in patients underwent VATS surgery with ICNB was calculated. The mean cumulative morphine consumption was 15±8 mg of patients underwent VATS with ICNB. We assume the difference between ICNB and ESPB group reach 5 mg and aim for a power of 95 % and a risk of 0.05 for a type-1 error, at least 42 for each group needing to be recruited. 50 patients for each group, total 100 patients will be collected to avoid dropouts. Patient will be allocated to one of the trial groups using a computer-generated random number table once the consent was approved. First group is ICNB group and the second group is ESPB group. The general anesthesia agents, induction process and routine care are the same for both groups. Once aforementioned routine cares are done, the patient will be turn into lateral decubitus position. Echo-guided ESP block will be performed after patients are turned into lateral decubitus position in ESP group; on the other side, local anesthetics will be injected at incision site and intrathoracic intercostal nerve block will be performed in ICNB group right after the surgeon makes the incision site and get into chest cavity. Pain score (VAS) and cumulative morphine consumption will be recorded in PACU, postoperative 24H, 48H, and before discharge. Recovery condition will be evaluated via QoR-15 questionnaire in postoperative 24H, furthermore, we will follow up the patient's pain and recovery status 3 months after the operation. After collecting above data, the effect of ESP group and ICNB group on acute pain relieve, chronic pain control and recovery enhancement will be evaluated.

Registry
clinicaltrials.gov
Start Date
October 16, 2020
End Date
October 16, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Postoperative analgesic consumption

Time Frame: Postoperative 48 hours

Cumulative morphine consumption in postoperative two days

Pain intensity

Time Frame: Postoperative 48 hours

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

Secondary Outcomes

  • Recovery quality: questionnaire(Postoperative 24 hours)

Study Sites (1)

Loading locations...

Similar Trials