Randomized clinical trial of transdermal fentanyl patch as part of fast-track thoracic surgery postoperative pain management protocol

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN17761785

Enrollment

Registered

2018-10-29

Start date

2018-10-08

Completion date

Unknown

Last updated

2021-02-08

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

Conditions

Postoperative pain intensity in patients after video-assisted thoracoscopic surgery Surgery

Interventions

Simple randomization based on a single sequence of random assignments, allocation ratio 1:1. After randomization patients will be allocated to two groups: transdermal fentanyl patch group (TFP) and pl

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age = 18 years 2. Lung resection (lobectomy, segmentectomy or wedge resection) performed by two-port VATS 3. WHO performance status range between 0 and 2 4. BMI range between 19 and 29

Exclusion criteria

Exclusion criteria: 1. Prior use of nonsteroidal anti-inflammatory drugs or opioid analgesics 2. Particular drug intolerance (fentanyl, bupivacaine, acetaminophen, trimeperidine, lornoxicam) 3. Postoperative hospital stay > 8 days 4. VATS conversion to thoracotomy 5. Mental disorders 6. Narcotic addiction 7. Chronic pain syndrome 8. Inability to assess severity of pain using Visual Analogue Scale (VAS)

Design outcomes

Primary

Measure	Time frame
Intensity of postoperative pain assessed by visual analogue pain scale (VAS) and scored on a numeric rating scale from 0 (no pain) to 10 (the worst imaginable pain). Assessed before surgery, directly after the surgery, 3-5 hours later, on the first and second postoperative day and on the day of discharge. After discharge patients will be followed-up twice by telephone to assess pain severity on the next day after discharge and 30 days after discharge.	—

Measure

Time frame

Intensity of postoperative pain assessed by visual analogue pain scale (VAS) and scored on a numeric rating scale from 0 (no pain) to 10 (the worst imaginable pain). Assessed before surgery, directly after the surgery, 3-5 hours later, on the first and second postoperative day and on the day of discharge. After discharge patients will be followed-up twice by telephone to assess pain severity on the next day after discharge and 30 days after discharge.

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Secondary

Measure	Time frame
1. Presence of nausea or vomiting, signs of respiratory depression and confusion, assessed by asking before surgery, directly after the surgery, 3-5 hours later, on the first and second postoperative day, on the day of discharge, as well as on the next day after discharge and 30 days after discharge 2. Requirement of rescue medication (trimeperidine) for breakthrough pain, length of postoperative hospital stay and duration of chest drainage collected from patients' history on the day of discharge	—

Measure

Time frame

1. Presence of nausea or vomiting, signs of respiratory depression and confusion, assessed by asking before surgery, directly after the surgery, 3-5 hours later, on the first and second postoperative day, on the day of discharge, as well as on the next day after discharge and 30 days after discharge 2. Requirement of rescue medication (trimeperidine) for breakthrough pain, length of postoperative hospital stay and duration of chest drainage collected from patients' history on the day of discharge

—

Countries

Latvia

Contacts

Public ContactAnastasija Bistrova

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026