NCT04303585

Brief Summary

Thoracic surgery is characterized by acute perioperative pain. There are different ways to provide analgesia, such as intravenous analgesics (opioids or non-opioids) or loco-regional procedures; these techniques are often used together in the context of a multimodal approach to pain management, in order to exploit their synergistic action and minimize side effects. In this observational prospective multicentric study the investigators evaluate the effectiveness of two routinely administered ultrasound guided loco-regional analgesic techniques in providing analgesia to patients undergoing mini-invasive lung-resective thoracic surgery. The two techniques compared are the serratus anterior plane (SAP) block and the erector spinae plane (ESP) block.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2019

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 27, 2019

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 11, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

July 2, 2020

Status Verified

July 1, 2020

Enrollment Period

3 years

First QC Date

March 8, 2020

Last Update Submit

July 1, 2020

Conditions

SAP Block Versus ESP BlockPain, PostoperativeEvaluation of Locoregional TechniquesMultimodal Pain Management

Keywords

SAP blockESP blockPain managementMini-invasiveThoracic surgerySAPESPLocoregionalMultimodal

Outcome Measures

Primary Outcomes (1)

  • Morphine consumption

    Evaluation of morphine consumption in the first 24 hours after surgery

    First 24 hours after surgery

Secondary Outcomes (4)

  • Intraoperative opioid consumption

    Duration of surgical procedure

  • Numeric Rating Scale (NRS)

    First 24 hours after surgery, then after 3 months

  • Analgesic rescue and corticosteroids

    First 24 hours after surgery

  • Side effects

    First 24 hours after surgery

Study Arms (2)

SAP block

This group includes patients who receive preoperative Serratus Anterior Plane block

Procedure: SAP block

ESP block

This group includes patients who receive preoperative Erector Spinae Plane block

Procedure: ESP block

Interventions

SAP blockPROCEDURE

The anesthesiologist performs SAP block immediately before surgery under ultrasound guide

SAP block
ESP blockPROCEDURE

The anesthesiologist performs ESP block immediately before surgery under ultrasound guide

ESP block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are hospitalized in one of the centers taking part in the study undergoing mini-invasive lung-resective thoracic surgery.

You may qualify if:

  • Lung-resective thoracic surgery (lobectomy, bilobectomy, segmentectomy and wedge resection) with videothoracoscopic or mini-thoracotomic approach (maximum duration 180 minutes)
  • BMI ranging from 18 to 30
  • Age \> 18 years
  • ASA I-III
  • Ultrasound guided preoperative ESP block or SAP block
  • Remifentanil as intraoperative opioid

You may not qualify if:

  • Patient's refusal
  • Weight \< 50 kg
  • Pregnancy
  • Emergent surgery
  • Chronic opioid therapy
  • History of drug or benzodiazepine addiction or alcohol abuse
  • Previous thoracic surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Cliniche Humanitas Gavazzeni

Bergamo, 24125, Italy

RECRUITING

A.O.U. Città della Salute e della Scienza - Molinette Hospital

Torino, 10126, Italy

RECRUITING

Cattinara Hospital

Trieste, 34149, Italy

RECRUITING

Related Publications (13)

  • Okmen K, Okmen BM. The efficacy of serratus anterior plane block in analgesia for thoracotomy: a retrospective study. J Anesth. 2017 Aug;31(4):579-585. doi: 10.1007/s00540-017-2364-9. Epub 2017 Apr 26.

    PMID: 28447227BACKGROUND

  • McGovern I, Walker C, Cox F. Pain relief after thoracotomy. Br J Anaesth. 2007 Jun;98(6):844; author reply 844-5. doi: 10.1093/bja/aem112. No abstract available.

    PMID: 17519266BACKGROUND

  • Wenk M, Schug SA. Perioperative pain management after thoracotomy. Curr Opin Anaesthesiol. 2011 Feb;24(1):8-12. doi: 10.1097/ACO.0b013e3283414175.

    PMID: 21084984BACKGROUND

  • Doan LV, Augustus J, Androphy R, Schechter D, Gharibo C. Mitigating the impact of acute and chronic post-thoracotomy pain. J Cardiothorac Vasc Anesth. 2014 Aug;28(4):1048-56. doi: 10.1053/j.jvca.2014.02.021. No abstract available.

    PMID: 25107721BACKGROUND

  • Khalil AE, Abdallah NM, Bashandy GM, Kaddah TA. Ultrasound-Guided Serratus Anterior Plane Block Versus Thoracic Epidural Analgesia for Thoracotomy Pain. J Cardiothorac Vasc Anesth. 2017 Feb;31(1):152-158. doi: 10.1053/j.jvca.2016.08.023. Epub 2016 Aug 21.

    PMID: 27939192BACKGROUND

  • Luis-Navarro JC, Seda-Guzman M, Luis-Moreno C, Lopez-Romero JL. The erector spinae plane block in 4 cases of video-assisted thoracic surgery. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Apr;65(4):204-208. doi: 10.1016/j.redar.2017.12.004. Epub 2018 Jan 11. English, Spanish.

    PMID: 29336785BACKGROUND

  • Blanco R, Parras T, McDonnell JG, Prats-Galino A. Serratus plane block: a novel ultrasound-guided thoracic wall nerve block. Anaesthesia. 2013 Nov;68(11):1107-13. doi: 10.1111/anae.12344. Epub 2013 Aug 7.

    PMID: 23923989BACKGROUND

  • 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.

    PMID: 27501016BACKGROUND

  • Scimia P, Basso Ricci E, Droghetti A, Fusco P. The Ultrasound-Guided Continuous Erector Spinae Plane Block for Postoperative Analgesia in Video-Assisted Thoracoscopic Lobectomy. Reg Anesth Pain Med. 2017 Jul/Aug;42(4):537. doi: 10.1097/AAP.0000000000000616. No abstract available.

    PMID: 28632673BACKGROUND

  • Rao Kadam V, Currie J. Ultrasound-guided continuous erector spinae plane block for postoperative analgesia in video-assisted thoracotomy. Anaesth Intensive Care. 2018 Mar;46(2):243-245. No abstract available.

    PMID: 29519230BACKGROUND

  • Chin KJ, Malhas L, Perlas A. The Erector Spinae Plane Block Provides Visceral Abdominal Analgesia in Bariatric Surgery: A Report of 3 Cases. Reg Anesth Pain Med. 2017 May/Jun;42(3):372-376. doi: 10.1097/AAP.0000000000000581.

    PMID: 28272292BACKGROUND

  • Leyva FM, Mendiola WE, Bonilla AJ, Cubillos J, Moreno DA, Chin KJ. Continuous Erector Spinae Plane (ESP) Block for Postoperative Analgesia after Minimally Invasive Mitral Valve Surgery. J Cardiothorac Vasc Anesth. 2018 Oct;32(5):2271-2274. doi: 10.1053/j.jvca.2017.12.020. Epub 2017 Dec 12. No abstract available.

    PMID: 29336964BACKGROUND

  • 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.

    PMID: 28188621BACKGROUND

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • Umberto Lucangelo, MD PhD

    University of Trieste

    STUDY CHAIR

  • Marzia Umari, MD

    University of Trieste

    PRINCIPAL INVESTIGATOR

  • Giovanni Albano, MD

    Cliniche Humanitas Gavazzeni

    PRINCIPAL INVESTIGATOR

  • Edoardo Ceraolo, MD

    A.O.U. Città della Salute e della Scienza - Molinette Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marzia Umari, MD

CONTACT

347 4688773marzia.umari@asuits.sanita.fvg.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 8, 2020

First Posted

March 11, 2020

Study Start

June 27, 2019

Primary Completion

June 30, 2022

Study Completion

July 31, 2022

Last Updated

July 2, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(3)