Prevention of Rebound Pain After Orthopaedic Surgery With Peripheral Nerve Block (REBOUND)_part B

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire Vaudois

About this trial

Rebound pain after peripheral nerve blocks reduces the benefits of regional anesthesia and increases opioid consumption. This rebound pain most likely results from suboptimal pain management, as patients receiving a peripheral nerve block are typically not given scheduled opioid doses. Oral Patient Controlled Analgesia (PCA) consists of an oral morphine prescription that allows patients to self-administer doses based on their pain score.

This study will compare patients undergoing elective orthopaedic surgery under general anaesthesia or sedation with a peripheral nerve block, receiving oral morphine PCA either with or without additional scheduled oral morphine doses.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients scheduled for elective orthopaedic surgery on the upper limb

Patients scheduled for elective orthopaedic surgery on the lower limb.

Score ASA I-III; Patients aged over 18 years; Signed informed consent.

Surgery under general anaesthesia or under sedation

Disqualifiers

Refusal or inability to understand the informed consent

Allergy to any of the following medications: ropivacaine, paracetamol, ibuprofen, ketorolac, morphine,sufentanil, ondansetron, or dexamethasone

Patients with long term opioid treatment

Bleeding diathesis

Trial design

Design model

Parallel

Treatments tested in this trial

  • Morphine provided via oral PCA

    Drug

    Morphine will be administered according to a scheduled regimen (20mg slow release oral morphine at fixed 12-hour intervals), with additional oral PCA on demand for breakthrough pain (VAS \> 4), following the same bedside tablet procedure as in the control group. The maximum allowed dose through oral PCA will be 6 tablets (10mg each) per 24-hour period.

  • Morphine provided via oral PCA + morphine administered at a scheduled regimen

    Drug

    morphine will be administered according to a scheduled regimen (20mg slow-release oral morphine at fixed 12-hour intervals), with additional oral PCA on demand for breakthrough pain (VAS \> 4), following the same bedside tablet procedure as in the control group. The maximum allowed dose through oral PCA will be 6 tablets (10mg each) per 24-hour period.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Scheduled groupExperimental treatment 1 intervention
Group B: On-demand groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Worst pain score during the first 24 hours after surgery

Highest postoperative pain score during the first 24 hours after surgery, measured using a 0-10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable

Time frame
24 hours postoperatively

Secondary outcomes

1

Minimal pain score during the first 12 hours after surgery

Lowest postoperative pain score during the first 12 hours after surgery, measured using a 0-10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable

Time frame
12 hours postoperatively
2

Rebound pain score measured using the Visual Analog Scale (VAS)

Rebound pain score calculated as the difference between the highest postoperative pain score within the first 24 hours after surgery and the lowest postoperative pain score within the first 12 hours after surgery. Pain intensity is assessed using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable. Higher rebound pain scores indicate greater pain rebound

Time frame
From surgery until 24 hours postoperatively
3

Rest and dynamic pain scores

Rest and dynamic pain scores, measured using a 0-10 Visual Analogue Score (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable

Time frame
At 2, 12, 24, 36, 48, 60, and 72 hours after surgery
4

Incidence of severe pain

Pain evaluated at \>7/10, measured using a 0-10 Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates the worst pain imaginable

Time frame
From surgery through 3 months after surgery

Other outcomes

Sponsors and contacts

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