ESPB Versus INB With PCIA in Video-assisted Thoracic Surgery

NCT03682354 | Completed

• 1 other identifier: M2018123
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Lung Diseases

Keywords

Erector spinae plane block; Video-assisted thoracic surgery;; Intercostal nerve block; Patient-controlled intravenous analgesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pain score (NRS)

  8, 24,48 hours from the end of procedure

• Analgesics consumption

  During operation,4, 8, 24,48 hours from the end of procedure

• Incidence of side effects and complication during study

  During operation,4, 8, 24,48 hours from the end of procedure

Study Arms (2)

Intercostal Nerve Block with PCIA

ACTIVE COMPARATOR

Intercostal Nerve Block with patient-controlled intravenous analgesia

Drug: Intercostal Nerve Block with PCIA

Erector Spinae Plane Block (ESPB)

EXPERIMENTAL

Continuous Erector Spinae Plane Block

Drug: Erector Spinae Plane Block (ESPB)

Interventions

Intercostal Nerve Block with PCIA DRUG

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.

Intercostal Nerve Block with PCIA

Erector Spinae Plane Block (ESPB) DRUG

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.

Erector Spinae Plane Block (ESPB)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients to receive video assisted thoracoscopic lobectomy or bullectomy .

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

Location

Related Publications (1)

• Wang T, Wang X, Yu Z, Li M. Programmed Intermittent Bolus for Erector Spinae Plane Block Versus Intercostal Nerve Block With Patient-controlled Intravenous Analgesia in Video-assisted Thoracoscopic Surgery: A Randomized Controlled Noninferiority Trial. Clin J Pain. 2024 Feb 1;40(2):99-104. doi: 10.1097/AJP.0000000000001174.

  PMID: 37975501 DERIVED

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Min Li

  Peking University Third Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2018
• First Posted: September 24, 2018
• Study Start: September 27, 2018
• Primary Completion: March 15, 2019
• Study Completion: March 15, 2019
• Last Updated: March 27, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)