ESPB Versus INB With PCIA in Video-assisted Thoracic Surgery

Lung Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03682354
• Other study ID #: M2018123
• Status: Completed
• Phase: N/A
• Start date: September 27, 2018
• Est. completion date: March 15, 2019

Study information

• Verified date: March 2019
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: March 15, 2019
• Est. primary completion date: March 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Peking University Third Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Analgesics consumption	Analgesics include opioids and nonsteroidal anti-inflammatory drugs	During operation,4, 8, 24,48 hours from the end of procedure
Secondary	Incidence of side effects and complication during study	Side effects and complication	During operation,4, 8, 24,48 hours from the end of procedure