Post Surgical Multimodal Analgesia With Oral Strong Opioids

Not yet recruiting

• Conditions: Orthopedic Procedures; Arthroplasty; Fracture Fixation
• Interventions: Drug: Multimodal analgesia with oral strong opioids

• Registration Number: NCT06554457
• Lead Sponsor: Tri-Service General Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-09
• Study Start: 2024-08-12
• Study First Submitted QC: 2024-08-14
• Last Update Submitted: 2024-08-14
• Study First Posted: 2024-08-15
• Last Update Posted: 2024-08-15
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fracture fixation	Multimodal analgesia with oral strong opioids	Fracture of upper or lower limbs or pelvis requiring internal fixation surgery
Spinal fusion	Multimodal analgesia with oral strong opioids	Spinal fusion surgery
Arthroplasty	Multimodal analgesia with oral strong opioids	Joint replacement surgery

Primary Outcome Measures

Name	Time	Method
Change in pain scores from baseline	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 Outcome Measures

Name	Time	Method
Occurence of adverse events	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.
Compliance of oral strong opioids	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.
Physician's global impression - improvement scale(CGI-I)	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
Satisfation of the pain control as per patients' report outcome	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.

Trial Locations

Locations (1)

TriService General Hospital; 🇨🇳 Taipei, Taiwan