Post Surgical Multimodal Analgesia With Oral Strong Opioids (ORORA)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Arthroplasty; Orthopedic Procedures; Fracture Fixation
• Intervention / Treatment: Drug: Multimodal analgesia with oral strong opioids

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Tsu-te Yeh, MD; Phone Number: 88081 886-2-87923311; Email: tsutey@gmail.com
• Study Contact Backup: Name: Tim TH Wang, PhD; Phone Number: 886-939081832; Email: asahi.tim@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 114
    • TriService General Hospital
    • Contact: Tsu-te Yeh, MD; Email: tsutey@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fracture fixation; Fracture of upper or lower limbs or pelvis requiring internal fixation surgery	Drug: Multimodal analgesia with oral strong opioids; Physician's choice of post-surgical multimodal analgesia with an oral strong opioid as the backbone analgesics
Spinal fusion; Spinal fusion surgery	Drug: Multimodal analgesia with oral strong opioids; Physician's choice of post-surgical multimodal analgesia with an oral strong opioid as the backbone analgesics
Arthroplasty; Joint replacement surgery	Drug: Multimodal analgesia with oral strong opioids; Physician's choice of post-surgical multimodal analgesia with an oral strong opioid as the backbone analgesics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain scores from baseline	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.	Twice daily during hospitalization (approximately within 1 week), at the first return 1 day visit and at 3 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurence of adverse events	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.	During hospitalization (approximately within 1 week)
Compliance of oral strong opioids	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.	During hospitalization (approximately within 1 week)
Physician's global impression - improvement scale(CGI-I)	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	During hospitalization (approximately within 1 week), at the first return 1 day visit and at 3 months after surgery
Satisfation of the pain control as per patients' report outcome	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.	End of hospitalization (approximately 1 week after surgery)

Collaborators and Investigators

• Sponsor: Tri-Service General Hospital
• Investigators: Principal Investigator: Tsu-te Yeh, MD, TriService General Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 12, 2024
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: August 9, 2024
• First Submitted That Met QC Criteria: August 14, 2024
• First Posted (Actual): August 15, 2024

Study Record Updates

• Last Update Posted (Actual): August 15, 2024
• Last Update Submitted That Met QC Criteria: August 14, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: ORORA24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only anonymized and de-identified information can be collected from the participants as per institutional review board's approval.