ESPB Versus INB With PCIA in Video-assisted Thoracic Surgery

Erector Spinae Plane Block Versus Intercostal Nerve Block Combined With Patient-controlled Intravenous Analgesia in Video-assisted Thoracic Surgery

A randomized prospective trial to test the non-inferiority of erector spinae plane block (ESPB) in comparison with intercostal nerve block combined with patient-controlled intravenous analgesia in Thoracoscopic lung surgery

Study Overview

• Status: Completed
• Conditions: Lung Diseases
• Intervention / Treatment: Drug: Intercostal Nerve Block with PCIA; Drug: Erector Spinae Plane Block (ESPB)

Detailed Description

For patients undergoing thoracic surgery, postoperative pain greatly limited their recovery.Multimodal analgesia have shown good efficacy but without reaching full pain relief.

The primary goal of this study is to observe the effect of ultrasound-guided erector spinae plane block in comparison with intercostal nerve block combined with patient-controlled intravenous analgesia in video assisted thoracic lung surgery.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Peking University Third Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients to receive video assisted thoracoscopic lobectomy or bullectomy .

Exclusion Criteria:

• 1. Patient refusal 2. Heavy skin eruption and infection at site of injection. 3. Coagulopathy. 4. Allergy to local anesthetics. 5. Taking analgesics.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intercostal Nerve Block with PCIA; Intercostal Nerve Block with patient-controlled intravenous analgesia	Drug: Intercostal Nerve Block with PCIA; Intercostal nerve block consists in the injection of Ropivacaine (4 ml,0.5%) in related intercostal spaces. Patient-controlled intravenous analgesia regimen is conducted with sufentanil.
Experimental: Erector Spinae Plane Block (ESPB); Continuous Erector Spinae Plane Block	Drug: Erector Spinae Plane Block (ESPB); Erector Spinae Plane Block consists in the injection of Ropivacaine (20ml, 0.5%), in the anatomical plane between the Erector Spinae muscles and transverse process, laterally to the spinous process of T5 . The catheter was inserted and secured in place under ecographic guidance, and a patient-controlled regional anesthesia regimen was conducted with 0.2% ropivacaine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score (NRS)	Numeric Rating Scale is an 11-point scale used by doctors to evaluate patients' pain, where 0 is no pain and 10 the worst imaginable pain. For postoperative patients, an higher score shows inadequate analgesia and worse outcome.	4 hours from the end of procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score (NRS)	Numeric Rating Scale is an 11-point scale used by doctors to evaluate patients' pain, where 0 is no pain and 10 the worst imaginable pain. For postoperative patients, an higher score shows inadequate analgesia and worse outcome.	8, 24,48 hours from the end of procedure
Analgesics consumption	Analgesics include opioids and nonsteroidal anti-inflammatory drugs	During operation,4, 8, 24,48 hours from the end of procedure
Incidence of side effects and complication during study	Side effects and complication	During operation,4, 8, 24,48 hours from the end of procedure

Collaborators and Investigators

• Sponsor: Peking University Third Hospital
• Investigators: Study Chair: Min Li, Peking University Third Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2018
• Primary Completion (Actual): March 15, 2019
• Study Completion (Actual): March 15, 2019

Study Registration Dates

• First Submitted: August 26, 2018
• First Submitted That Met QC Criteria: September 20, 2018
• First Posted (Actual): September 24, 2018

Study Record Updates

• Last Update Posted (Actual): March 27, 2019
• Last Update Submitted That Met QC Criteria: March 26, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Erector spinae plane block; Intercostal nerve block; Video-assisted thoracic surgery;; Patient-controlled intravenous analgesia
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases
• Other Study ID Numbers: M2018123

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No