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Postoperative Pain ManagementARP-TSNCT07694141

Postoperative Analgesia in Thoracic Surgery

An observational study of Postoperative Pain Management, run by Hospital Universitario de Gran Canaria Doctor Negrín at 1 site in Spain.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Analgesic management in thoracic surgery presents a particular challenge for the anesthesiologist, given the intensity of postoperative pain associated with thoracotomy, a surgical procedure that can impact respiratory function and the patient's subsequent recovery. Epidural analgesia is the gold standard. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Postoperative Pain Management
What is being tested?
Postoperative pain through Visual analogue scale and Postoperative complications
How many people
160 participants
Where
1 siteSpain
Study dates
15 Nov 2025to 30 Jan 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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: The study will include ASA I-III patients scheduled for thoracic surgery at the Doctor Negrín University Hospital of Gran Canaria

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ángel Becerra Bolaños, MD PhD contact

+34676229025

angbecbol@gmail.com

Aurelio Rodríguez-Pérez, MD PhD contact

676229025

arodperp@gobiernodecanarias.org

Spain1 site, 1 recruiting
  • Hospital Universitario de Gran Canaria Doctor Negrín

    Las Palmas de Gran Canaria, Las Palmas, 35002

    Ángel Becerra Bolaños, MD PhD, 0034928450370, angbecbol@gmail.com

    Aurelio Rodríguez-Pérez, MD PhD, 0034928450371, arodperp@gobiernodecanarias.org

    Recruiting

Other trials in Spain

About this study

Official title: Postoperative Analgesia in Patients Undergoing Thoracic Surgery

Analgesic management in thoracic surgery presents a particular challenge for the anesthesiologist, given the intensity of postoperative pain associated with thoracotomy, a surgical procedure that can impact respiratory function and the patient's subsequent recovery. Epidural analgesia is the gold standard. When epidural catheter placement is not feasible, erector spinae plane block is a safe alternative. The ultrasound target is easily visualized, and the injection site is far from the neuraxis, pleura, and major vascular structures. Consequently, this block has been incorporated into standard clinical practice as a treatment option for patients with complex cases or as an alternative approach when epidural catheter placement is not feasible. The primary objective of this study is to assess the effectiveness of postoperative analgesia in patients undergoing elective thoracic surgery.

Study Population Design 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.

Read the detailed description

The gold standard for managing pain after thoracic surgery is the administration of local anesthetics, with or without opioids, through a catheter placed in the epidural space during the 48-hour postoperative period. However, there are instances 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 necessitates the consideration of alternatives (it may lead to hypotension or bradycardia that compromises patients with cardiovascular disease, urinary retention, nerve injury, or spinal hematoma). This has prompted anesthesiologists to explore alternative options, including paravertebral block, which has shown promising results. However, it is important to note that paravertebral block is not entirely risk-free and has contraindications similar to those of epidural analgesia. When epidural catheter placement is not feasible, erector spinae plane block is a safe alternative. The ultrasound target is easily visualized, and the injection site is far from the neuraxis, pleura, and major vascular structures. Consequently, this block has been incorporated into standard clinical practice as a treatment option for patients with complex cases or as an alternative approach when epidural catheter placement is not feasible. The primary objective of this study is to assess the effectiveness of 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.

The management of perioperative analgesia will adhere to standard clinical protocols, following a comprehensive evaluation by the anesthesiologist responsible for intraoperative anesthesia management.

Patients with ASA I-III classification who have scheduled thoracic surgery at the Doctor Negrín University Hospital of Gran Canaria between November 1 and December 31, 2025, will be included in the study. It is estimated that 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. For all patients undergoing a regional procedure (epidural catheter or erector spinae plane block), 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. The puncture point will be located 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, allowing for the visualization of 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 in accordance with standard clinical practice. Following the completion of the procedure and 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.

Being tested
Postoperative pain through Visual analogue scale, Postoperative complications
Keywords
thoracic surgery, pain, epidural analgesia
Medical subject headings
Pain

What participants receive

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

  • Postoperative pain through Visual analogue scaleDiagnostic test

    Postoperative pain will be assessed using the visual analog pain scale at 1, 3, 6, 24, and 48 hours postoperatively.

  • Postoperative complicationsDiagnostic test

    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.

Study groups in NCT07694141
Study groupRoleWhat they receive
Epidural analgesiaPatients whose analgesic management will be achieved through an epidural catheter.
Receives: Diagnostic Test: Postoperative pain through Visual analogue scale; Diagnostic Test: Postoperative complications
Erector spinae plane blockPatients whose analgesic management will be achieved through an erector spinae plane block
Receives: Diagnostic Test: Postoperative pain through Visual analogue scale; Diagnostic Test: Postoperative complications

What is being measured

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

  1. Postoperative pain

    To evaluate the postoperative analgesic effect in patients undergoing elective thoracic surgery according to the Visual Analogue Scale, from 0 to 10.

    Measured: 24 postoperative hours

Secondary outcomes (2)
  1. 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).

    Measured: 24 postoperative hours.

  2. 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).

    Measured: First postoperative week.

Timeline

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

  1. First posted9 Jul 2026
  2. Study start15 Nov 2025
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion30 Jan 2027 (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
160 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07694141
Sponsor's protocol ID
2020-339-1
Acronym
ARP-TS
Status last verified
Jul 2026
First submitted
3 Jul 2026
Last updated
20 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Postoperative Pain Management, run by Hospital Universitario de Gran Canaria Doctor Negrín at 1 site in Spain.

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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 20 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Ángel Becerra Bolaños, MD PhD (+34676229025, angbecbol@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative pain (time frame: 24 postoperative hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 20 Jul 2026; AzTrials last refreshed its copy on 30 Oct 2026.

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