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NCT Number: NCT06554457

Post Surgical Multimodal Analgesia With Oral Strong Opioids

This is a prospective observational case study, focusing on the clinical effectiveness of oral strong opioids for pain management following common orthopedic surgeries.The study aims to evaluate the effectiveness of multimodal analgesia with oral strong opioids, reduce common opioid-related side effects, and improve patient compliance and satisfaction.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

TriService General Hospital

Taipei, 114, Taiwan

Location contact

Tsu-te Yeh, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 18 or older
  • Must undergo one of the following treatments:

(1) Fracture of upper or lower limbs or pelvis requiring internal fixation surgery (2) Spinal fusion surgery (3) Joint replacement surgery 3. Requiring multimodal analgesics for postoperative pain control, with oral strong opioids as the primary opioid analgesic, as assessed by his/her physician.

  • Voluntarily sign the informed consent form and agree to the collection of clinical questionnaires and medical-related information for this study.

Exclusion criteria

  • Patients who have not received any or have only received oral potent opioids for no more than 1 day during the postoperative hospitalization period (including those known to be intolerant or allergic to opioid medications).
  • Patients who have received or are expected to use long-acting opioid injections within 7 days before surgery or during the postoperative hospitalization period.
  • Patients who use patient-controlled analgesics for pain control after surgery.
  • Patients with a history of substance abuse or who require continuous treatment with other opioid receptor agonists or antagonists (such as naloxone or methadone).
  • Patients with a history of mental illness who continue to require medication control from 28 days before surgery and until discharge.
  • Other cases deemed ineligible by the study investigator.

Treatment and study plan

Multimodal analgesia with oral strong opioids

Drug

Physician's choice of post-surgical multimodal analgesia with an oral strong opioid as the backbone analgesics

Primary outcomes

  1. Change in pain scores from baseline

    Time frame: Twice daily during hospitalization (approximately within 1 week), at the first return 1 day visit and at 3 months after surgery

    Assess the efficacy of including oral strong opioids in multimodal pain control. For this objective, we will observe changes in pain scores among participants during postoperative treatment.

Secondary outcomes

  1. Occurence of adverse events

    Time frame: During hospitalization (approximately within 1 week)

    Avoid common adverse reactions associated with traditional morphine-like drugs, such as respiratory depression and addiction, to enhance treatment safety and patient comfort. We will monitor the occurrence rate of adverse reactions related to oral potent opioids.

  2. Compliance of oral strong opioids

    Time frame: During hospitalization (approximately within 1 week)

    Improvement the convenience of analgesic medication by transitioning from injections to oral administration, making it easier for patients to accept and adhere to the treatment plan. The compliance rate of oral strong opioids will be measured.

  3. Physician's global impression - improvement scale(CGI-I)

    Time frame: During hospitalization (approximately within 1 week), at the first return 1 day visit and at 3 months after surgery

    Effectiveness of the pain control will be assessed by a 7-point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention. Scale 1= Very much improved and scale 7 = very much worse

  4. Satisfation of the pain control as per patients' report outcome

    Time frame: End of hospitalization (approximately 1 week after surgery)

    Enhance patient acceptance of the treatment by using oral administration, boosting confidence in the treatment plan and increasing adherence and effectiveness. Patient satisfaction and pain improvement will be assessed through a 5-point scale questionnaire. 1=very much discontent, 2=discontent, 3=fair, 4=satisfied, 5=very much satisfied.

Study contacts

Contact information is provided by the study sponsor or research team.

Tim TH Wang, PhD

CONTACT

[email protected]

886-939081832

Tsu-te Yeh, MD

CONTACT

[email protected]

886-2-87923311 ext. 88081

Sponsors and collaborators

Lead sponsor

Tri-Service General Hospital (TSGH)

Other

Registry information

Official study title

Study on the Clinical Effectiveness of Oral Strong Opioids for Common Orthopedic Surgeries Following Multimodal Analgesia

Acronym: ORORA

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 15, 2024
Registry last updated
Aug 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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