SERRATHOR TRIAL : Interest of the Novel Serratus Plane Block in Post Operative Analgesia After Video-Assisted Thoracoscopic Lobectomy

NCT03867695 | Unknown

• 1 other identifier: 6755
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief Summary

Pain after thoracic surgery remains a challenge for anesthetists. Although VATS for lobectomy is associated with fewer complications compared to thoracotomy, pain after VATS needs to be treated with opioids. Opioids may lead to PONV, respiratory depression, sedation and pruritus. As part of multimodal analgesia and opioids sparing, several local regional techniques has been described: paravertebral block, thoracic epidural analgesia, intercostal block. To date, there is no gold standard for regional anesthesia after VATS. Serratus plane block is a local regional technique, recently described for analgesia after breast surgery and ribs fracture. In our hospital center, since 2016, we used the Serratus plane block for patients scheduled for lobectomy VATS : a local retrospective trial showed that SPB was associated with a lower consumption of morphine. The purpose of this randomized controlled double blinded study is to evaluate the analgesic effect of the Serratus plane block, added to a general anesthesia on post operative pain control after VATS lobectomy.

Conditions

Video Assisted Thoracoscopic Surgery; Lobectomy; Pain Post Operative; Regional Anesthesia

Keywords

Serratus plane block; Analgesia after VATS; Lobectomy VATS

Outcome Measures

Primary Outcomes (1)

• Total intravenous morphine consumption (mg) in the PACU and department.

  Including the dose of titration while the patient is in PACU and PCA up to 24h postoperatively.

  24 hours

Study Arms (2)

Serratus Block

EXPERIMENTAL

At the end of the lobectomy VATS procedure, 0,5 mL/kg of 0.375% ropivacaine will be administered. Under ultrasonography assistance, block will be performed at the fifth rib in the midaxillary line. Local anesthetic will be injected either superficial to the serratus anterior muscle or deep underneath the muscle. Anesthesiologists, and all the nurses and caring staff involved in this study will be blinded. Solutions of ropivacaine will be prepared identically by the central pharmacy, without any possible identification of the product.

Drug: Ropivacaine

Placebo Block - Control Group

PLACEBO COMPARATOR

Patients will receive a placebo injection with 0,5 mL/kg of sterile normal solution. Under ultrasonography assistance, placebo will be injected at the fifth rib in the midaxillary line, either superficial to the serratus anterior muscle or deep underneath the muscle. Anesthesiologists, and all the nurses and caring staff involved in this study will be blinded. Solutions of sterile saline will be prepared identically by the central pharmacy, without any possible identification of the product.

Drug: sterile saline

Interventions

Ropivacaine DRUG

At the end of the lobectomy VATS procedure, 0,5 mL/kg of 0.375% ropivacaine will be administered.

Serratus Block

sterile saline DRUG

Patients will receive a placebo injection with 0,5 mL/kg of sterile normal solution

Placebo Block - Control Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing lobectomy VATS
• Older \> 18 years
• Patients who meet criteria of ASA 1 to 3 class

You may not qualify if:

• Patient's refusal to participate in the study
• Psychiatric disorder (impossibility to collect the informed consent)
• Patient under juridical protection
• On going an other study
• Non balanced epilepsy
• grade auriculo-ventricular heart block without pacing
• Severe hepatocellular insufficiency
• Anti arrhythmic treatment : class III of the Vaughan William's classification
• Pregnant patient or/and breastfeeding
• History of opioid abuse
• Allergy to local anesthetic drug or opioids

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine

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

Study Officials

• Bob HEGER

  Les Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bob HEGER

CONTACT

+33 3.69.55.04.43; Bob.Heger@chru-strasbourg.fr

Gharib AJOB

CONTACT

+33 3.69.55.07.92; Gharib.ajob@chru-strasbourg.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2019
• First Posted: March 8, 2019
• Study Start: July 1, 2019
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2020
• Last Updated: June 4, 2019

Record last verified: 2019-03

Locations

FR (1)