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

NCT04167046 | Unknown

• 1 other identifier: 2019/98
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thoracic Surgery

Outcome Measures

Primary Outcomes (1)

• Pain assessment at H+48

  Numerical pain rating scale: 0 (no pain at all) to 10 (worst imaginable pain)

  Day 2 after surgery

Secondary Outcomes (4)

• Postoperative pain assessment at other times

  Hour 2, Day 1, and Day 3 after surgery

• Total consumption of morphine (per and postoperative)

  Hour 2, Day 1, Day 2 and Day 3 after surgery

• Frequency of adverse effects related to morphine Frequency of morphine side effects

  Hour 2, Day 1, Day 2 and Day 3 after surgery

• Length of hospital stay

  Through study completion, an average of 1 year

Study Arms (2)

Control

Patients in this group did not receive an erector spinae block. Data are obtained retrospectively (years 2017 and 2018).

Erector spinae block

Patients in this group receive an erector spinae block. Data will be obtained prospectively.

Procedure: Erector spinae block

Interventions

Erector spinae block PROCEDURE

Preoperative erector spinae block.

Erector spinae block

Eligibility Criteria

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

Study Population

Patients undergoing first rib resection for thoracic outlet syndrome

You may qualify if:

• First rib resection for thoracic outlet syndrome

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (1)

Département d'Anesthésie-Réanimation du CHU d'Angers

Angers, 49100, France

Location

Study Officials

• Emmanuel Rineau, MD

  University Hospital of Angers, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmanuel Rineau, MD

CONTACT

+33241353951; erineau@live.fr

Siaudeau Hélène, MD

CONTACT

+33241353951

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 18, 2019
• Study Start: November 1, 2019
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: November 18, 2019

Record last verified: 2019-11

Locations

FR (1)