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.
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.
Spain1 site, 1 recruiting
- 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
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.
- Conditions
- Postoperative Pain Management
- 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 group | Role | What they receive |
|---|---|---|
| Epidural analgesia | Patients 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 block | Patients 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.
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)
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.
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.
- First posted9 Jul 2026
- Study start15 Nov 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor Negrín
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ángel Becerra-Bolaños, MD PhD, Hospital Universitario de Gran Canaria Doctor Negrín
- Investigators
- Ángel Becerra, MD PhD, Principal investigator, Hospital Universitario de Gran Canaria Doctor Negrín
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesia in Patients Undergoing Thoracic Surgery
- ClinicalTrials.gov ID
- NCT07694141
- Acronym / sponsor ID
- ARP-TS / 2020-339-1
- Conditions
- Postoperative Pain Management
- Keywords
- thoracic surgery, pain, epidural analgesia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor NegrínUniversity, hospital or other
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epidural analgesia | – | Diagnostic Test: Postoperative pain through Visual analogue scale, Diagnostic Test: Postoperative complicationsPatients whose analgesic management will be achieved through an epidural catheter. |
| Erector spinae plane block | – | Diagnostic Test: Postoperative pain through Visual analogue scale, Diagnostic Test: Postoperative complicationsPatients whose analgesic management will be achieved through an erector spinae plane block |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (4 listed)
- Patients undergoing thoracic surgery between July 1 and October 31, 2020.
- Age over 18.
- ASA I-III.
- Signed informed consent
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postoperative pain through Visual analogue scalePostoperative pain will be assessed using the visual analog pain scale at 1, 3, 6, 24, and 48 hours postoperatively. | Diagnostic test | Epidural analgesia, Erector spinae plane block |
| Postoperative complicationsThe 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. | Diagnostic test | Epidural analgesia, Erector spinae plane block |
Primary outcome
Postoperative pain
Time frame: 24 postoperative hours
To evaluate the postoperative analgesic effect in patients undergoing elective thoracic surgery according to the Visual Analogue Scale, from 0 to 10.
2 secondary outcomes
Postoperative analgesics consumption
Time frame: 24 postoperative hours.
Postoperative complications
Time frame: First postoperative week.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ángel Becerra, MD PhD principal investigator
Hospital Universitario de Gran Canaria Doctor Negrín
1 site in 1 country: see every site and its status.
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.