Erector Spinae Block in First Rib Resection: a Monocentric Before-after Study

Thoracic Surgery Clinical Trial

— MERCOTE  

Official title:

Bloc Des Muscles Erecteurs du Rachis Pour Chirurgie d'exérèse de première côte Dans le Cadre du Syndrome du défilé Cervico-thoracique: évaluation Avant-après au CHU d'Angers.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04167046
• Other study ID #: 2019/98
• Status: Not yet recruiting
• Start date: November 2019
• Est. completion date: March 2021

Study information

• Verified date: November 2019
• Source: University Hospital, Angers
• Contact: Emmanuel Rineau, MD
• Phone: +33241353951
• Email: erineau[@]live.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

First rib resection surgery for thoracic outlet syndrome is associated with an intense postoperative pain. It leads to significant consumption of nonsteroidal anti-inflammatory drugs and opioids, and hospitalization for several days.

In our center, first rib resection surgery was usually performed under general anesthesia combined with diffuse local infiltration of the axillary fossa. Erector spinae block is an interfascial block where a local anesthetic is injected between the erector spinae muscle and the transverse process, in order to obtain a multimetameric analgesia. It has now shown its efficacy and its safety in thoracic and abdominal surgeries by decreasing the morphine consumption and pain scores. Since November 2018, this erector spinae block is systematically performed preoperatively for first rib resection in our center, in association with a general anesthesia. Patient satisfaction seems important but remains to be assessed objectively.

In a before-after study, our goal is to assess the impact of the use of erector spinae block on postoperative pain in the first rib resection surgery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• First rib resection for thoracic outlet syndrome

Related Conditions & MeSH terms

• Thoracic Surgery

Intervention

Procedure:
• Erector spinae block
Preoperative erector spinae block.

Locations

Country	Name	City	State
France	Département d'Anesthésie-Réanimation du CHU d'Angers	Angers

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain assessment at H+48	Numerical pain rating scale: 0 (no pain at all) to 10 (worst imaginable pain)	Day 2 after surgery
Secondary	Postoperative pain assessment at other times	Numerical pain rating scale: 0 (no pain at all) to 10 (worst imaginable pain)	Hour 2, Day 1, and Day 3 after surgery
Secondary	Total consumption of morphine (per and postoperative)		Hour 2, Day 1, Day 2 and Day 3 after surgery
Secondary	Frequency of adverse effects related to morphine Frequency of morphine side effects		Hour 2, Day 1, Day 2 and Day 3 after surgery
Secondary	Length of hospital stay		Through study completion, an average of 1 year