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

Sponsor

University Hospital, Strasbourg, France (Other)

Overall Status

Unknown status

CT.gov ID

NCT03867695

Collaborator

(none)

130

Enrollment

Location

Arms

Anticipated Duration (Months)

10.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Video Assisted Thoracoscopic Surgery Lobectomy Pain Post Operative Regional Anesthesia	Drug: Ropivacaine Drug: sterile saline	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

130 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Supportive Care

Official Title:

SERRATHOR Trial : Analgesic Effect of Serratus Plane Block After Video-Assisted Thoracoscopic Surgery Lobectomy

Anticipated Study Start Date :

Jul 1, 2019

Anticipated Primary Completion Date :

Jul 1, 2019

Anticipated Study Completion Date :

Jul 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: Ropivacaine At the end of the lobectomy VATS procedure, 0,5 mL/kg of 0.375% ropivacaine will be administered.
Placebo Comparator: 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.	Drug: sterile saline Patients will receive a placebo injection with 0,5 mL/kg of sterile normal solution

Arm

Intervention/Treatment

Experimental: 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.

Drug: Ropivacaine

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

Placebo Comparator: 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.

Drug: sterile saline

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

Outcome Measures

Primary Outcome Measures

Total intravenous morphine consumption (mg) in the PACU and department. [24 hours]
Including the dose of titration while the patient is in PACU and PCA up to 24h postoperatively.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Les Hôpitaux Universitaires de Strasbourg	Strasbourg		France	67091

Sponsors and Collaborators

University Hospital, Strasbourg, France

Investigators

Principal Investigator: Bob HEGER, Les Hôpitaux Universitaires de Strasbourg

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Strasbourg, France

ClinicalTrials.gov Identifier:

NCT03867695

Other Study ID Numbers:

6755

First Posted:

Mar 8, 2019

Last Update Posted:

Jun 4, 2019

Last Verified:

Mar 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Strasbourg, France

Serratus plane block

Analgesia after VATS

Lobectomy VATS

Additional relevant MeSH terms:

Pain, Postoperative

Ropivacaine

Study Results

No Results Posted as of Jun 4, 2019