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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04581616
• Other study ID #: 202008040RINC
• Status: Completed
• Phase: N/A
• Start date: October 16, 2020
• Est. completion date: October 16, 2022

Study information

• Verified date: October 2020
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 16, 2022
• Est. primary completion date: October 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Pain, Postoperative
• Postoperative Pain
• Ultrasound Therapy; Complications

Intervention

Procedure:
• Intrathoracic Intercostal Nerve Block
Injection of local anesthetic into the subcostal groove, to achieve analgesia for chest region.
• Erector Spinae Plane Block
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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Postoperative analgesic consumption	Cumulative morphine consumption in postoperative two days	Postoperative 48 hours
Secondary	Recovery quality: questionnaire	Postoperative recovery quality assessed by Quality of recovery-15 (QoR-15) questionnaire, with a score range of 0-150, (poor recovery to excellent recovery)	Postoperative 24 hours