Post Surgical Multimodal Analgesia With Oral Strong Opioids

NCT06554457 | Not Yet Recruiting

• 1 other identifier: ORORA24
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthopedic Procedures; Arthroplasty; Fracture Fixation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Occurence of adverse events

  During hospitalization (approximately within 1 week)

• Compliance of oral strong opioids

  During hospitalization (approximately within 1 week)

• 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

• Satisfation of the pain control as per patients' report outcome

  End of hospitalization (approximately 1 week after surgery)

Study Arms (3)

Fracture fixation

Fracture of upper or lower limbs or pelvis requiring internal fixation surgery

Drug: Multimodal analgesia with oral strong opioids

Spinal fusion

Spinal fusion surgery

Drug: Multimodal analgesia with oral strong opioids

Arthroplasty

Joint replacement surgery

Drug: Multimodal analgesia with oral strong opioids

Interventions

Multimodal analgesia with oral strong opioids DRUG

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

Arthroplasty; Fracture fixation; Spinal fusion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

TriService General Hospital

Taipei, 114, Taiwan

Location

Study Officials

• Tsu-te Yeh, MD

  TriService General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tsu-te Yeh, MD

CONTACT

886-2-87923311; tsutey@gmail.com

Tim TH Wang, PhD

CONTACT

886-939081832; asahi.tim@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Surgeon

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 15, 2024
• Study Start: August 12, 2024
• Primary Completion: July 31, 2025
• Study Completion: July 31, 2025
• Last Updated: August 15, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)