SAP Versus ESP Block in Multimodal Pain Management in Mini-invasive Thoracic Surgery: an Observational Prospective Multicentric Study

NCT ID: NCT04303585

Last Updated: 2020-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

170 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-27

Study Completion Date

2022-07-31

Brief Summary

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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.

Detailed Description

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Whatever the loco-regional technique is (SAP block or ESP block), it must have been administered in the immediate preoperative phase; both procedures are routinely used for analgesic purpose in the clinical practice of the three centers involved in the study and are performed under ultrasound guide. Using medical records, data collected by Acute Pain Service nurses and patients' interviews useful data will be collected: demographic and clinical characteristics (age, sex, weight, comorbidities), surgical data (type of procedure, surgical approach and duration of surgery) and anesthesia data (type of block, dose and type of local anesthetic with record of potential side effects), intraoperative and postoperative opioid and non-opioid analgesic consumption (and rescue if needed) with record of potential side effects, pain evaluation in the first 24 hours after surgery and after at 3 months.

Conditions

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SAP Block Versus ESP Block Pain, Postoperative Evaluation of Locoregional Techniques Multimodal Pain Management

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SAP block

This group includes patients who receive preoperative Serratus Anterior Plane block

SAP block

Intervention Type PROCEDURE

The anesthesiologist performs SAP block immediately before surgery under ultrasound guide

ESP block

This group includes patients who receive preoperative Erector Spinae Plane block

ESP block

Intervention Type PROCEDURE

The anesthesiologist performs ESP block immediately before surgery under ultrasound guide

Interventions

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SAP block

The anesthesiologist performs SAP block immediately before surgery under ultrasound guide

Intervention Type PROCEDURE

ESP block

The anesthesiologist performs ESP block immediately before surgery under ultrasound guide

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cliniche Humanitas Gavazzeni

OTHER

Sponsor Role collaborator

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

OTHER

Sponsor Role collaborator

University of Trieste

OTHER

Sponsor Role lead

Responsible Party

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Marzia Umari

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Umberto Lucangelo, MD PhD

Role: STUDY_CHAIR

University of Trieste

Marzia Umari, MD

Role: PRINCIPAL_INVESTIGATOR

University of Trieste

Giovanni Albano, MD

Role: PRINCIPAL_INVESTIGATOR

Cliniche Humanitas Gavazzeni

Edoardo Ceraolo, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Cliniche Humanitas Gavazzeni

Bergamo, , Italy

Site Status RECRUITING

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

Torino, , Italy

Site Status RECRUITING

Cattinara Hospital

Trieste, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Marzia Umari, MD

Role: CONTACT

347 4688773 ext. +39

Facility Contacts

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Giovanni Albano, MD

Role: primary

3356268223 ext. +39

Edoardo Ceraolo, MD

Role: primary

3474541469 ext. +39

Marzia Umari, MD

Role: primary

347 4688773 ext. +39

References

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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.

Reference Type BACKGROUND
PMID: 28447227 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17519266 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 21084984 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25107721 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27939192 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29336785 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23923989 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27501016 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28632673 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29519230 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28272292 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29336964 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28188621 (View on PubMed)

Other Identifiers

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145_2018 Blocco gran dentato

Identifier Type: -

Identifier Source: org_study_id

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