Does ESPB Improve Postoperative Quality of Recovery After VATS

NCT03756987 | Completed DMC

• 1 other identifier: K2018-10-001
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postoperative Pain

Keywords

ultrasound-guided; erector spinae plane block; quality of recovery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• postoperative pain: numeric rating scale

  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.

• cumulative opioid consumption

  Up to 48 hours after surgery.

• PACU discharge time

  Up to 2 hours

• Incidence of nausea and vomiting

  Up to 48 hours

• Incidence of dizziness

  Up to 48 hours

Study Arms (2)

ESPB group

EXPERIMENTAL

Patient will receive a single shot of Ropivacaine injection 0.5% 25 mL injected at the erector spinae plane.

Drug: Ropivacaine Injection

Control Group

PLACEBO COMPARATOR

Patient will receive a single shot of normal saline 25 mL injected at the erector spinae plane.

Drug: Normal saline

Interventions

Ropivacaine Injection DRUG

Ropivacaine will be injected in the erector spinae plane

Also known as: ESPB group

ESPB group

Normal saline DRUG

Normal saline will be injected in the erector spinae plane.

Also known as: Control group

Control Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists' physical status class of I or II
• scheduled for elective VATS

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fujian Provincial Hospital: lead

Study Sites (1)

Yusheng Yao

Fuzhou, Fujian, 350001, China

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; Saline Solution; Control Groups

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Xiaochun Zheng, MD

  Fujian Provincial Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The randomization sequence will be computer generated. Allocation concealment will be carried out via concealed assignments in opaque, sealed, and consecutively numbered envelopes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: November 28, 2018
• Study Start: December 28, 2018
• Primary Completion: November 12, 2019
• Study Completion: November 14, 2019
• Last Updated: January 28, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 3 months and ending 3 years following article publication.
• Access Criteria: All of the individual participant data collected during the trial, the study protocol, statistical analysis plan, and clinical study report can be accessed with approval from the corresponding author.

Locations

CN (1)