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SAP Block Versus ESP BlockNCT04303585

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

An observational study of SAP Block Versus ESP Block and Pain, Postoperative, run by University of Trieste at 3 sites in Italy.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
SAP block and ESP block
Type of treatment
Surgery or procedure
How many people
170 participants
Where
3 sitesItaly
Study dates
27 Jun 2019to 31 Jul 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

Marzia Umari, MD contact

347 4688773 ext. +39

marzia.umari@asuits.sanita.fvg.it

Italy3 sites, 3 recruiting

  • Cliniche Humanitas Gavazzeni

    Bergamo, 24125

    Giovanni Albano, MD, 3356268223 ext. +39, giovanni.albano@gavazzeni.it

    Giovanni Albano, MD

    Recruiting

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

    Torino, 10126

    Edoardo Ceraolo, MD, 3474541469 ext. +39, edoceraolo@gmail.com

    Edoardo Ceraolo, MD

    Recruiting

  • Cattinara Hospital

    Trieste, 34149

    Marzia Umari, MD, 347 4688773 ext. +39, marzia.umari@asuits.sanita.fvg.it

    Marzia Umari, MD

    Recruiting

Other trials in Italy

About this study

Official title: Blocco Del Dentato Anteriore e Blocco Del Muscolo Erettore Della Colonna Vertebrale Nella Gestione Multimodale Del Dolore in Chirurgia Toracica Mininvasiva: Studio Osservazionale Prospettico Multicentrico

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.

Read the detailed description

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.

Being tested
SAP block, ESP block
Keywords
SAP block, ESP block, Pain management, Mini-invasive, Thoracic surgery, SAP, ESP, Locoregional, Multimodal
Medical subject headings
Pain, Postoperative, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAP blockProcedure or surgery

    The anesthesiologist performs SAP block immediately before surgery under ultrasound guide

  • ESP blockProcedure or surgery

    The anesthesiologist performs ESP block immediately before surgery under ultrasound guide

Study groups in NCT04303585
Study groupRoleWhat they receive
SAP blockThis group includes patients who receive preoperative Serratus Anterior Plane block
Receives: Procedure: SAP block
ESP blockThis group includes patients who receive preoperative Erector Spinae Plane block
Receives: Procedure: ESP block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Morphine consumption

    Evaluation of morphine consumption in the first 24 hours after surgery

    Measured: First 24 hours after surgery

Secondary outcomes (4)

  1. Intraoperative opioid consumption

    Evaluation of opioid consumption during lung-resective thoracic surgery

    Measured: Duration of surgical procedure

  2. Numeric Rating Scale (NRS)

    Evaluation of NRS for static, dynamic and cough-associated pain

    Measured: First 24 hours after surgery, then after 3 months

  3. Analgesic rescue and corticosteroids

    Evaluation of eventual administration of rescue analgesic drugs and corticosteroids in the first 24 hours after surgery

    Measured: First 24 hours after surgery

  4. Side effects

    Evaluation of eventual side effects related to the locoregional techinque or the analgesics used (LAST, hypotension, Post Operative Nausea and Vomiting (PONV) and opioid-related side effects) in the first 24 hours after surgery

    Measured: First 24 hours after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2020
  2. Study start27 Jun 2019
  3. Primary completion30 Jun 2022 (estimated)
  4. Study completion31 Jul 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
170 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04303585
Sponsor's protocol ID
145_2018 Blocco gran dentato
Status last verified
Jul 2020
First submitted
8 Mar 2020
Last updated
2 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28447227

  • 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.

    PubMed 17519266

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

    PubMed 21084984

  • 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.

    PubMed 25107721

  • 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.

    PubMed 27939192

  • 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.

    PubMed 29336785

  • 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.

    PubMed 23923989

  • 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.

    PubMed 27501016

  • 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.

    PubMed 28632673

  • 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.

    PubMed 29519230

  • 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.

    PubMed 28272292

  • 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.

    PubMed 29336964

  • 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.

    PubMed 28188621

Questions about this trial

What is this clinical trial studying?

An observational study of SAP Block Versus ESP Block and Pain, Postoperative, run by University of Trieste at 3 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Marzia Umari, MD (347 4688773 ext. +39, marzia.umari@asuits.sanita.fvg.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Morphine consumption (time frame: First 24 hours after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04303585, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2020.

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