Does ESPB Improve Postoperative Quality of Recovery After VATS

Postoperative Pain Clinical Trial

Official title:

Does Ultrasound-guided Erector Spinae Plane Block Improve Postoperative Quality of Recovery After Video-assisted Thoracic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03756987
• Other study ID #: K2018-10-001
• Status: Completed
• Phase: N/A
• Start date: December 28, 2018
• Est. completion date: November 14, 2019

Study information

• Verified date: January 2020
• Source: Fujian Provincial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Video-Assisted Thoracoscopic Surgery (VATS) is a minimally invasive surgery. Despite reduced surgical trauma compared to the traditional thoracotomy approach, pain control after VATS remains challenging. Regional analgesia may be a crucial component of multimodal postoperative pain management. The use of nerve blocks, such as the recently described erector spinae plane block (ESPB) has been shown in case reports to reduce pain and thus has the potential to improve patient recovery. This study aims to test the hypothesis that ultrasound-guided SPB would improve the quality of recovery after VATS by reducing acute postsurgical pain.

Description:

VATS is a minimally invasive surgical technique to remove intrathoracic lesions. VATS has become increasingly popular and gradually becoming the standard of care for lung surgery. Although acute pain after VATS is less than the traditional thoracotomy, patients still experience moderate amount of pain within the first 24 hours. However, the optimal regional analgesic technique for VATS procedures has not been established.

Thoracic epidural analgesia (TEA) and paravertebral block (PVB) have been tried to improve postoperative analgesia after VATS. Although TEA and PVB provides superior analgesia, these technologies accompanied by the rare but serious complications involving epidural hematoma, pneumothorax and total spinal anesthesia.

Erector spinae plane block (ESPB) is a novel and simple ultrasound-guided regional anesthetic technique, providing analgesia for the ipsilateral hemithorax. Ultrasound guidance is believed to improve peripheral and regional nerve block success rates and safety. ESPB is a technically easy to perform. ESPB has only been reported in case series but so far, no adverse events such as hypotension, hematoma or infection has been reported.

Given its safety, ease of performance and efficacy, the study aims to verify the hypothesis that combines ESPB with general anesthesia would accelerate functional recovery after breast cancer surgery. Our secondary aims were to examine ESPB's effect on analgesic outcomes (e.g., postoperative pain intensity, cumulative opioid consumption, postoperative nausea and vomiting, dizziness, the postanesthesia care unit discharge time and patients' satisfaction) in patients undergoing VATS.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: November 14, 2019
• Est. primary completion date: November 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists' physical status class of I or II

• scheduled for elective VATS

Exclusion Criteria:

• a history of allergy to local anesthetics

• known coagulation disorders

• infection near the puncture site

• chronic opioid use

• inability to communicate,

• other reasons that not appropriate for this study.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Ropivacaine Injection
Ropivacaine will be injected in the erector spinae plane
• Normal saline
Normal saline will be injected in the erector spinae plane.

Locations

Country	Name	City	State
China	Yusheng Yao	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Provincial Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the 40-item Quality of Recovery (QoR-40) score	QoR-40 incorporates 40 questions assessing 5 dimensions of recovery, including emotional status, physical comfort, psychological support, physical independence, and pain. The global QoR-40 score ranges from 40 (extremely poor quality of recovery) to 200 (excellent quality of recovery).	The QoR-40 questionnaire was completed by patients at 24 hours after surgery.
Secondary	postoperative pain: numeric rating scale	0-10 numeric rating scale for pain (0 minimal pain and 10 worst pain ever)	Acute postoperative pain was assessed using an numeric rating scale (NRS) at 0.5, 1, 2, 4, 8, 12, 24, and 48 hours following video-assisted thoracic surgery.
Secondary	cumulative opioid consumption	We recorded opioid(sufentanil) consumption at 48 hours after surgery. consumption at 6, 24, and 48 hours after surgery.cumulative opioid (sufentanil) consumption	Up to 48 hours after surgery.
Secondary	PACU discharge time	Post-anesthetic recovery length of stay in minutes	Up to 2 hours
Secondary	Incidence of nausea and vomiting	Patient reported sensation of nausea and incidence of vomiting related to opioid intake.	Up to 48 hours
Secondary	Incidence of dizziness	Patient reported incidence of dizziness related to opioid intake.	Up to 48 hours
Secondary	patient's satisfaction: numeric rating scale	Patient's satisfaction was evaluated with a 10-point numerical rating scale ranging from 1 (highly unsatisfactory) to 10 (highly satisfactory).	Patient's satisfaction was evaluated at 48 hours postoperatively.