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

NCT ID: NCT03867695

Last Updated: 2019-06-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-31
• Study Completion Date: 2020-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Serratus Block

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.

Group Type: EXPERIMENTAL

Ropivacaine

Intervention Type: DRUG

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

Placebo Block - Control Group

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.

Group Type: PLACEBO_COMPARATOR

sterile saline

Intervention Type: DRUG

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

Interventions

Ropivacaine

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

Intervention Type: DRUG

sterile saline

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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
• 3 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Strasbourg, France

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bob HEGER

Role: PRINCIPAL_INVESTIGATOR

Les Hôpitaux Universitaires de Strasbourg

Locations

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, , France

Countries

France

Central Contacts

Bob HEGER

Role: CONTACT

Bob.Heger@chru-strasbourg.fr

+33 3.69.55.04.43

Gharib AJOB

Role: CONTACT

Gharib.ajob@chru-strasbourg.fr

+33 3.69.55.07.92

Facility Contacts

Bob HEGER

Role: primary

Bob.Heger@chru-strasbourg.fr

+33 3.69.55.04.43

Other Identifiers

6755

Identifier Type: -

Identifier Source: org_study_id