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

Sponsor

University of Trieste (Other)

Overall Status

Unknown status

CT.gov ID

NCT04303585

Collaborator

Cliniche Humanitas Gavazzeni (Other), A.O.U. Città della Salute e della Scienza - Molinette Hospital (Other)

170

Enrollment

Locations

37.1

Anticipated Duration (Months)

56.7

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
SAP Block Versus ESP Block Pain, Postoperative Evaluation of Locoregional Techniques Multimodal Pain Management	Procedure: SAP block Procedure: 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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

170 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Actual Study Start Date :

Jun 27, 2019

Anticipated Primary Completion Date :

Jun 30, 2022

Anticipated Study Completion Date :

Jul 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
SAP block This group includes patients who receive preoperative Serratus Anterior Plane block	Procedure: SAP block The anesthesiologist performs SAP block immediately before surgery under ultrasound guide
ESP block This group includes patients who receive preoperative Erector Spinae Plane block	Procedure: ESP block The anesthesiologist performs ESP block immediately before surgery under ultrasound guide

Arm

Intervention/Treatment

SAP block

This group includes patients who receive preoperative Serratus Anterior Plane block

Procedure: SAP block

The anesthesiologist performs SAP block immediately before surgery under ultrasound guide

ESP block

This group includes patients who receive preoperative Erector Spinae Plane block

Procedure: ESP block

The anesthesiologist performs ESP block immediately before surgery under ultrasound guide

Outcome Measures

Primary Outcome Measures

Morphine consumption [First 24 hours after surgery]
Evaluation of morphine consumption in the first 24 hours after surgery

Secondary Outcome Measures

Intraoperative opioid consumption [Duration of surgical procedure]
Evaluation of opioid consumption during lung-resective thoracic surgery
Numeric Rating Scale (NRS) [First 24 hours after surgery, then after 3 months]
Evaluation of NRS for static, dynamic and cough-associated pain
Analgesic rescue and corticosteroids [First 24 hours after surgery]
Evaluation of eventual administration of rescue analgesic drugs and corticosteroids in the first 24 hours after surgery
Side effects [First 24 hours after surgery]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Cliniche Humanitas Gavazzeni	Bergamo	Italy	24125
2	A.O.U. Città della Salute e della Scienza - Molinette Hospital	Torino	Italy	10126
3	Cattinara Hospital	Trieste	Italy	34149

Sponsors and Collaborators

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

Investigators

Study Chair: Umberto Lucangelo, MD PhD, University of Trieste
Principal Investigator: 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