ESPB Combined With Intercostal Nerve Block in VATs

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03949790
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12.5
• Patients Per Site Per Month: 4.8

Study Details

Study Description

Brief Summary

A randomized prospective trial to test the effect of additional Erector Spinae Plane Block (ESPB) with intercostal nerve block during video assisted thoracoscopic surgery.

Condition or Disease	Intervention/Treatment	Phase
Video Assisted Thoracoscopic Surgery	Procedure: ESPB and Intercostal nerve block; Procedure: Intercostal nerve block	N/A

Detailed Description

A prospective randomized trial which aims to evaluate effect of peripheral nerve block for pain management, the Erector Spinae Plane Block (ESPB) in patients undergoing video assisted thoracoscopic surgery with intercostal nerve block.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Erector Spinae Plane Block Combined With Intercostal Nerve Block in Video Assisted Thoracoscopic Surgery: a Randomized Study
• Actual Study Start Date: Jun 18, 2019
• Anticipated Primary Completion Date: Jun 1, 2020
• Anticipated Study Completion Date: Jul 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intercostal block with ESPB Performed ESPB in VATs with intercostal nerve block	Procedure: ESPB and Intercostal nerve block; Erector spinae plane block + Intercostal nerve block
Active Comparator: Intercostal block without ESPB Not Performed ESPB in VATs with intercostal nerve block	Procedure: Intercostal nerve block; Intercostal nerve block

Outcome Measures

Primary Outcome Measures

1. Postoperative Pain [1 hour after surgery]

   VAS score (Visual Analog Scale for Pain, 0-10, higher value represent a worse outcome)

Secondary Outcome Measures

1. Postoperative Pain [6 hours after surgery]

   VAS score (Visual Analog Scale for Pain, 0-10, higher value represent a worse outcome)

2. Postoperative Pain [12 hours after surgery]

   VAS score (Visual Analog Scale for Pain, 0-10, higher value represent a worse outcome)

3. Postoperative Pain [24 hours after surgery]

   VAS score (Visual Analog Scale for Pain, 0-10, higher value represent a worse outcome)

4. Postoperative Pain [48 hours after surgery]

   VAS score (Visual Analog Scale for Pain, 0-10, higher value represent a worse outcome)

5. Opioid consumption [postoperative 24 hours]

   cumulative total opioid consumption

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Wedge Resection or Lobectomy under VATS approach.

Exclusion Criteria:

• Age < 20 years

• Patients who has anatomical abnormality in any spine

• Patients who has skin infection near to be the present procedure site

• Intercostal nerve block is not performed during surgery

• Previous lung surgery history of affected side

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SMG - SNU Boramae Medical Center	Seoul		Korea, Republic of	07061

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

• Study Chair: Tae Kyong Kim, MD, phD, SMG-SNU Boramae

Study Documents (Full-Text)

None provided.

More Information

Publications

• Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11.
• Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
• Forero M, Rajarathinam M, Adhikary S, Chin KJ. Continuous Erector Spinae Plane Block for Rescue Analgesia in Thoracotomy After Epidural Failure: A Case Report. A A Case Rep. 2017 May 15;8(10):254-256. doi: 10.1213/XAA.0000000000000478.
• Forero M, Rajarathinam M, Adhikary S, Chin KJ. Erector spinae plane (ESP) block in the management of post thoracotomy pain syndrome: A case series. Scand J Pain. 2017 Oct;17:325-329. doi: 10.1016/j.sjpain.2017.08.013. Epub 2017 Sep 12.
• Hamilton DL, Manickam B. Erector spinae plane block for pain relief in rib fractures. Br J Anaesth. 2017 Mar 1;118(3):474-475. doi: 10.1093/bja/aex013.

• Responsible Party: Tae Kyong Kim, Assistant Professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT03949790
• Other Study ID Numbers: 2019-107
• First Posted: May 14, 2019
• Last Update Posted: Sep 24, 2019
• Last Verified: Sep 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Sep 24, 2019