Efficacy of Erector Spinae Plane Block for Postoperative Analgesia in Adult Patients Undergoing Thoracoscopy

• Sponsor: Eric Albrecht (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03454191
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 72
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The erector spinae plane block has been recently described as an effective analgesic postoperative pain treatment in case reports. It consists of injecting local anaesthetics below the erector spinae muscle, at the level of the transverse processes, in order to anaesthetize the thoracic roots coming out from the spinal cord. However, the analgesic efficacy has never been demonstrated in a randomized controlled trial. Therefore, the objective of this study is to investigate the analgesic benefit of this block on patients scheduled for thoracoscopy.

Condition or Disease	Intervention/Treatment	Phase
Pain, Postoperative	Procedure: Erector spinae plane block; Procedure: No injection	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Efficacy of Erector Spinae Plane Block for Postoperative Analgesia in Adult Patients Undergoing Thoracoscopy
• Actual Study Start Date: Feb 1, 2018
• Anticipated Primary Completion Date: Feb 1, 2024
• Anticipated Study Completion Date: Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Erector spinae plane block	Procedure: Erector spinae plane block; Injection of local anaesthetics below the erector spinae muscle after induction of anaesthesia
Placebo Comparator: Placebo	Procedure: No injection; No injection

Outcome Measures

Primary Outcome Measures

1. IV morphine consumption [24 postoperative hours]

   mg

Secondary Outcome Measures

1. IV morphine consumption [2 postoperative hours]

   mg

2. IV morphine consumption [48 postoperative hours]

   mg

3. Pain scores [2, 24, 24 postoperative hours]

   Visual analog scale, 0-10

4. Chronic pain scores [3 and 6 postoperative months]

   Visual analog scale, 0-10

5. Forced vital capacity [24 and 48 postoperative hours]

   L

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients scheduled for thoracoscopy

• physical status I-III

Exclusion Criteria:

• allergy to local anaesthetics

• other contraindications to peripheral nerve blocks

• patients suffering from chronic pain condition

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesia, Centre Hospitalier Universitaire Vaudois and University of Lausanne	Lausanne	Vaud	Switzerland	1011

Sponsors and Collaborators

• Eric Albrecht

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Eric Albrecht, Program director of regional anaesthesia, Centre Hospitalier Universitaire Vaudois
• ClinicalTrials.gov Identifier: NCT03454191
• Other Study ID Numbers: CER 2017-01772
• First Posted: Mar 5, 2018
• Last Update Posted: Mar 9, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pain, Postoperative

Study Results

No Results Posted as of Mar 9, 2022