Multimodal Postoperative Analgesia Following OSA Surgery

NCT ID: NCT04483427

Last Updated: 2021-09-28

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-20

Study Completion Date

2022-12-31

Brief Summary

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Assessment of the clinical efficacy and adverse effects of multimodal analgesic regimen consisting of nalbuphine combined with ketorolac using IV continuous infusion silicon device (Accufuser) for postoperative analgesia following multilevel OSA surgeries

Detailed Description

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Conditions

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Obstructive Sleep Apnea

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OSA patients after multilevel surgery

Group Type EXPERIMENTAL

Nalbuphine, ketorolac, accufuser

Intervention Type COMBINATION_PRODUCT

multimodal analgesic regimen consisting of nalbuphine combined with ketorolac using IV continuous infusion silicon device (Accufuser)

Interventions

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Nalbuphine, ketorolac, accufuser

multimodal analgesic regimen consisting of nalbuphine combined with ketorolac using IV continuous infusion silicon device (Accufuser)

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* physical status of American Society of Anesthesiologists (ASA) II
* age between 30 - 50 years
* OSA patients diagnosed by polysomnography and stop-bang questionnaire
* enrolled for multilevel OSA surgery

Exclusion Criteria

* history of allergy to the study drugs
* history of hepatic, cardiopulmonary or renal disease
* history of any chronic pain on medication
* history of substance abuse
* psychiatric disorder
* lack of patient cooperation.
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bahaa Mohammed Refaie

OTHER

Sponsor Role lead

Responsible Party

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Bahaa Mohammed Refaie

Lecturer of anesthesia and ICU

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Bahaa M Refaie, MD

Role: PRINCIPAL_INVESTIGATOR

Lecturer of anesthesia and ICU sohag university

Mohammed E Ahmed, MD

Role: STUDY_DIRECTOR

Lecturer of ENT sohag university

A M Elhalwagy, MD

Role: STUDY_CHAIR

Consultant of pain medicine

Locations

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Sohag faculty of medicine

Sohag, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Bahaa M Refaie, MD

Role: CONTACT

0201026887257

Facility Contacts

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Bahaa M Refaie, MD

Role: primary

Other Identifiers

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1984

Identifier Type: -

Identifier Source: org_study_id

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