Analgesic Non Inferiority of the Thoracic Bi-block in Comparison With Thoracic Epidural for VATS.

NCT04538235 | Completed DMC

• 1 other identifier: RECHMPL19_0473
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Video-Assisted thoracic surgery (VATS) is the standard treatment for localized lung cancer. However, there is no consensus on analgesic management in patients undergoing VATS. The aim of the study is to compare the analgesic efficacy of thoracic epidural with that a "Bi-block" combining an Erector Spinae muscle plane Block (ESP) and a Serratus Anterior Block (SAP) in patients undergoing VATS for lung or pleural surgery. Our main hypothesis is that the analgesic efficacy of the Bi-block, assessed by morphine consumption, is not inferior to that provided by a thoracic epidural during the first 48 hours after VATS. We conducted a age, gender and type of surgery-matched retrospective cohort study in the Department of Thoracic Anesthesia of the Montpellier University Hospital (France).

Conditions

Erector Spinae Muscle Plane Block; Serratus Anterior Muscle Plane Block; Video-Assisted Thoracic Surgery; Lung Cancer; Pleural Diseases; Thoracic Epidural; Analgesia; Enhanced Recovery After Surgery

Keywords

regional anesthesia; video-assisted thoracic surgery

Outcome Measures

Primary Outcomes (1)

• cumulative morphine consumption on postoperative day 2

  cumulative morphine consumption on postoperative day 2, including the morphine administered in Post anesthesia care unit (PACU), on postoperative day 0, 1 and 2.

  postoperative day 2

Secondary Outcomes (7)

• non-opioid analgesics consumption on postoperative day 2

  postoperative day 2

• Pain assessed by visual analog pain scale (VAS)

  up to postoperative day 2

• Urinary retention

  up to postoperative day 2

• hypotension

  up to postoperative day 2

• pleural drain duration

  up to postoperative day 2

Study Arms (2)

Bi-block (Serratus and erector spinae block) group

The Bi-block consisted in performing an ESP block followed by a SAP block on the side ipsilateral to the thoracic surgery. For the ESP block, 40 ml of Ropivacaine 2mg/ml were injected under the erector spinae muscle plane, at the level of the 4th thoracic vertebra. For the SAP block, 40 ml of Ropivacaine 2 mg/ml were injected under the serratus anterior muscle plane. The cumulative dose of Ropivacaine did not exceed 3 mg/kg. Regional anesthesia was performed before surgery.

Procedure: Thoracic Regional Analgesia

Thoracic Epidural Analgesia (TEA) group

The thoracic epidural was performed according to a standardized protocol, with a Tuohy needle via the median puncture technique, at the level of T4-T5 intervertebral space. After a test dose of 2 to 3 ml of Lidocaine, 5 to 10 ml of a mixture of Ropivacaine 2 mg/ml and Sufentanil 0.5 µg / mL were injected. Epidural continuous administration was performed with the same mixture of anesthetic connected to a CADD Solis ™ pump set according to a PCEA protocol adapted to the patient's weight (continuous flow rate from 3 to 6 ml/h, self-administered bolus dose from 3 to 5 ml, refractory period 30 min). Regional anesthesia was performed before surgery.

Procedure: Thoracic Regional Analgesia

Interventions

Thoracic Regional Analgesia PROCEDURE

In the TEA group, a thoracic epidural was performed before VATS. In the Bi-block group, a SAP block associated with an ESP block were performed before surgical incision under general anesthesia.

Also known as: Thoracic Epidural Analgesia, Bi-block, a regional anesthesia technique combining a serratus anterior block with an erector spinae block

Bi-block (Serratus and erector spinae block) group; Thoracic Epidural Analgesia (TEA) group

Eligibility Criteria

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

Study Population

Each patient enrolled in the Bi-block group were matched by age, gender and type of surgery with two controls in the TEA group. Patients not-matched were secondarily excluded.

You may qualify if:

• To be over 18.
• To be scheduled for VATS in the center of the study during the study period.
• Thoracic Epidural analgesia of Bi-block analgesia.

You may not qualify if:

• Chronic pain or opioid use before surgery (6 months).
• Postoperative hospitalization in ICU during the first two days.
• Postoperative surgical complication needing surgical revision during the first two days.
• Preoperative dementia or other psychiatric disease incompatible with VAS pain scoring.

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Intensive Care Unit, D - University hospital of Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Lung Neoplasms; Pleural Diseases; Agnosia

Interventions

Tea

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Pierre Sentenac, MD

  Montpellier University Hospital

  PRINCIPAL INVESTIGATOR

• Pascal H Colson, MD, PhD

  Montpellier University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 4, 2020
• Study Start: October 20, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: September 4, 2020

Record last verified: 2020-09

Locations

FR (1)