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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04303585
Enrollment
170
Registered
2020-03-11
Start date
2019-06-27
Completion date
2022-07-31
Last updated
2020-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

SAP block, ESP block, Pain management, Mini-invasive, Thoracic surgery, SAP, ESP, Locoregional, Multimodal

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.

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.

Interventions

PROCEDURESAP block

The anesthesiologist performs SAP block immediately before surgery under ultrasound guide

PROCEDUREESP block

The anesthesiologist performs ESP block immediately before surgery under ultrasound guide

Sponsors

Cliniche Humanitas Gavazzeni
CollaboratorOTHER
A.O.U. Città della Salute e della Scienza - Molinette Hospital
CollaboratorOTHER
University of Trieste
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Morphine consumptionFirst 24 hours after surgeryEvaluation of morphine consumption in the first 24 hours after surgery

Secondary

MeasureTime frameDescription
Intraoperative opioid consumptionDuration of surgical procedureEvaluation of opioid consumption during lung-resective thoracic surgery
Numeric Rating Scale (NRS)First 24 hours after surgery, then after 3 monthsEvaluation of NRS for static, dynamic and cough-associated pain
Analgesic rescue and corticosteroidsFirst 24 hours after surgeryEvaluation of eventual administration of rescue analgesic drugs and corticosteroids in the first 24 hours after surgery
Side effectsFirst 24 hours after surgeryEvaluation 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

Countries

Italy

Contacts

Primary ContactMarzia Umari, MD
marzia.umari@asuits.sanita.fvg.it347 4688773

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026