Postoperative Analgesia in Thoracic Surgery (ARP-TS)

Postoperative Analgesia in Patients Undergoing Thoracic Surgery

Analgesic management in thoracic surgery is a challenge for the anesthesiologist, as thoracotomy is one of the surgical procedures with the most intense postoperative pain, which can impact respiratory function and the patient's subsequent recovery. Epidural analgesia is the gold standard. When epidural catheter placement is not possible, erector spinae plane block is a safe alternative, as the ultrasound target is easily visualized and the injection site is far from the neuraxis, pleura, and major vascular structures. Therefore, this block has been increasingly established in routine clinical practice as an option for patients with additional difficulties or as an alternative technique for those for whom epidural catheter placement is not possible. The main objective of this study is to evaluate postoperative analgesia in patients undergoing elective thoracic surgery.

Design and study population A prospective, observational follow-up study will be conducted. ASA I-III patients undergoing scheduled thoracic surgery between November 1 and December 31, 2025, will be included. Their analgesic management will be based on standard clinical practice.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain Management
• Intervention / Treatment: Diagnostic test: Postoperative pain through Visual analogue scale; Diagnostic test: Postoperative complications

Detailed Description

The gold standard for analgesic management after thoracic surgery is the administration of local anesthetic, with or without opioids, through a catheter placed in the epidural space during the 48 hours following surgery. However, there are situations in which the placement of this catheter is contraindicated (due to patient refusal, coagulation disorders, spinal pathology, etc.) or in which the risk-benefit assessment makes it necessary to consider alternatives (it may lead to hypotension or bradycardia that compromises patients with cardiovascular disease, urinary retention, nerve injury, or spinal hematoma). This has led anesthesiologists to seek alternatives, among which paravertebral block has been investigated, with excellent results, although it is not exempt from the risks associated with a central block and has contraindications similar to those of epidural analgesia. When epidural catheter placement is not possible, erector spinae plane block is a safe alternative, as the ultrasound target is easily visualized and the injection site is far from the neuraxis, pleura, and major vascular structures. Therefore, this block has been increasingly established in routine clinical practice as an option for patients with additional difficulties or as an alternative technique for those for whom epidural catheter placement is not possible. The main objective of this study is to evaluate postoperative analgesia in patients undergoing elective thoracic surgery.

Design and study population A prospective, observational cohort study will be conducted. Patients will be followed from the day of hospital admission (usually 24 hours before surgery, when informed consent will be requested) until hospital discharge.

Perioperative analgesic management will be carried out according to standard clinical practice, after evaluation by the anesthesiologist in charge of intraoperative anesthesia management.

ASA I-III patients scheduled for thoracic surgery at the Doctor Negrín University Hospital of Gran Canaria between November 1 and December 31, 2025, will be included in the study. An estimated 80 patients will be included in this prospective, observational study.

On the day of the procedure, analgesic management will be administered according to the standard clinical practice of the anesthesiologist responsible for the patient's clinical management. The anesthesiologist will be unaware that the patient's perioperative analgesic management will be evaluated by this study. In all patients for whom a regional procedure (epidural catheter or erector spinae plane block) is performed, standard aseptic measures will be followed during the procedure.

The epidural catheter will be placed according to standard clinical practice using the loss-of-resistance technique in the space between the dorsal spinous processes corresponding to the surgical wound site, prior to the patient's anesthesia induction. The anesthesiologist responsible for the patient's perioperative management will decide whether or not to use this catheter to administer analgesics during the intraoperative period or whether to administer intraoperative analgesics with or without the administration of intravenous opioids in combination with non-opioid analgesics.

For patients undergoing an erector spinae plane block, the procedure will be performed using ultrasound with a high-frequency linear ultrasound probe, locating the puncture point 3 cm lateral to the spinous process. The puncture is made at the level of T5, in the craniocaudal plane, using a 50 mm EchoPlex needle, until the needle bevel is seen at the level of the transverse process, immediately anterior to the erector spinae muscle group. At this point, 3 ml of the local anesthetic selected by the anesthesiologist in charge of perioperative management of the patient is injected, visualizing the dissection of the interfascial plane. If adequate dissection of this plane is confirmed during the injection of these 3 ml, the remaining local anesthetic will be injected until the target volume is reached, without exceeding the toxic dose for each patient. 7 Intraoperative anesthetic management will be carried out according to standard clinical practice. At the end of the procedure, after extubation, the patient will be transferred to the Post-Anesthesia Care Unit. Pain will be assessed using a numerical pain scale at 1, 3, 6, 24, and 48 hours postoperatively. Postoperative management will be carried out according to standard clinical practice. The patient's postoperative progress will also be assessed until hospital discharge.

• Study Type: Observational
• Enrollment (Estimated): 160

Contacts and Locations

• Study Contact: Name: Ángel Becerra Bolaños, MD PhD; Phone Number: +34676229025; Email: angbecbol@gmail.com
• Study Contact Backup: Name: Aurelio Rodríguez-Pérez, MD PhD; Phone Number: 676229025; Email: arodperp@gobiernodecanarias.org

Study Locations

• Spain
  • Las Palmas
    • Las Palmas de Gran Canaria, Las Palmas, Spain, 35002
      • Recruiting
      • Hospital Universitario de Gran Canaria Doctor Negrín
      • Contact: Ángel Becerra Bolaños, MD PhD; Phone Number: 0034928450370; Email: angbecbol@gmail.com
      • Contact: Aurelio Rodríguez-Pérez, MD PhD; Phone Number: 0034928450371; Email: arodperp@gobiernodecanarias.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study will include ASA I-III patients scheduled for thoracic surgery at the Doctor Negrín University Hospital of Gran Canaria between November 1 and December 31, 2025.

Description

Inclusion Criteria:

• Patients undergoing thoracic surgery between July 1 and October 31, 2020.
• Age over 18.
• ASA I-III.
• Signed informed consent

Exclusion Criteria:

• ASA IV-V.
• Chronic opioid treatment or treatment in the Chronic Pain Unit.
• Intravenous drug abuse.
• Local anesthetic allergy.
• Language barrier, cognitive impairment, or inability to participate in clinical assessment during the study.
• BMI <18 or >35 kg/m2

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Epidural analgesia; Patients whose analgesic management will be achieved through an epidural catheter.	Diagnostic test: Postoperative pain through Visual analogue scale; Postoperative pain will be assessed using the visual analog pain scale at 1, 3, 6, 24, and 48 hours postoperatively.; Diagnostic test: Postoperative complications; The patient's postoperative evolution will be assessed until hospital discharge, in order to define the appearance of postoperative complications classified according to Clavien-Dindo classification.
Erector spinae plane block; Patients whose analgesic management will be achieved through an erector spinae plane block	Diagnostic test: Postoperative pain through Visual analogue scale; Postoperative pain will be assessed using the visual analog pain scale at 1, 3, 6, 24, and 48 hours postoperatively.; Diagnostic test: Postoperative complications; The patient's postoperative evolution will be assessed until hospital discharge, in order to define the appearance of postoperative complications classified according to Clavien-Dindo classification.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	To evaluate the postoperative analgesic effect in patients undergoing elective thoracic surgery according to the Visual Analogue Scale, from 0 to 10.	24 postoperative hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative analgesics consumption	To compare the use of rescue analgesic medication in patients receiving any of the different regimens established in routine clinical practice at our hospital for perioperative analgesic management (epidural catheter, paravertebral block, erector spinae plane block).	24 postoperative hours.
Postoperative complications	To compare the appearance of postoperative complications in patients receiving any of the different regimens establishedat our hospital for perioperative analgesic management (epidural catheter, paravertebral block, erector spinae).	First postoperative week.

Collaborators and Investigators

• Sponsor: Hospital Universitario de Gran Canaria Doctor Negrín
• Investigators: Principal Investigator: Ángel Becerra, MD PhD, Hospital Universitario de Gran Canaria Doctor Negrín

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): January 30, 2027

Study Registration Dates

• First Submitted: July 3, 2026
• First Submitted That Met QC Criteria: July 3, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: July 3, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: pain; epidural analgesia; thoracic surgery
• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain
• Other Study ID Numbers: 2020-339-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No