Clinical trial NCT06554457: Post Surgical Multimodal Analgesia With Oral Strong Opioids
Official title: Study on the Clinical Effectiveness of Oral Strong Opioids for Common Orthopedic Surgeries Following Multimodal Analgesia
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Orthopedic Procedures
Arthroplasty
Fracture Fixation
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2024-08-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are hospitalized for the following surgical treatment may be enrolled:

1. Fracture of upper or lower limbs or pelvis requiring internal fixation surgery
2. Spinal fusion surgery
3. Joint replacement surgery

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. Aged 18 or older
2. 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.

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

Exclusion Criteria:

1. 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).
2. Patients who have received or are expected to use long-acting opioid injections within 7 days before surgery or during the postoperative hospitalization period.
3. Patients who use patient-controlled analgesics for pain control after surgery.
4. Patients with a history of substance abuse or who require continuous treatment with other opioid receptor agonists or antagonists (such as naloxone or methadone).
5. Patients with a history of mental illness who continue to require medication control from 28 days before surgery and until discharge.
6. Other cases deemed ineligible by the study investigator.

Primary outcomes:
measure: Change in pain scores from baseline
timeFrame: Twice daily during hospitalization (approximately within 1 week), at the first return 1 day visit and at 3 months after surgery
Secondary outcomes:
measure: Occurence of adverse events
timeFrame: During hospitalization (approximately within 1 week)
measure: Compliance of oral strong opioids
timeFrame: During hospitalization (approximately within 1 week)
measure: Physician's global impression - improvement scale(CGI-I)
timeFrame: During hospitalization (approximately within 1 week), at the first return 1 day visit and at 3 months after surgery
measure: Satisfation of the pain control as per patients' report outcome
timeFrame: End of hospitalization (approximately 1 week after surgery)
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: TriService General Hospital
Study officials:
affiliation: TriService General Hospital
name: Tsu-te Yeh, MD
role: PRINCIPAL_INVESTIGATOR
References: