Post Surgical Multimodal Analgesia With Oral Strong Opioids

NCT ID: NCT06554457

Last Updated: 2024-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-12

Study Completion Date

2025-07-31

Brief Summary

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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

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Conditions

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Orthopedic Procedures Arthroplasty Fracture Fixation

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Fracture fixation

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

Multimodal analgesia with oral strong opioids

Intervention Type DRUG

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

Spinal fusion

Spinal fusion surgery

Multimodal analgesia with oral strong opioids

Intervention Type DRUG

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

Arthroplasty

Joint replacement surgery

Multimodal analgesia with oral strong opioids

Intervention Type DRUG

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

Interventions

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Multimodal analgesia with oral strong opioids

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tri-Service General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tsu-Te Yeh

Attending Surgeon

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tsu-te Yeh, MD

Role: PRINCIPAL_INVESTIGATOR

TriService General Hospital

Locations

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TriService General Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Central Contacts

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Tsu-te Yeh, MD

Role: CONTACT

886-2-87923311 ext. 88081

Tim TH Wang, PhD

Role: CONTACT

886-939081832

Facility Contacts

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Tsu-te Yeh, MD

Role: primary

Other Identifiers

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ORORA24

Identifier Type: -

Identifier Source: org_study_id

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