NCT04483427

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 23, 2020

Completed
2 months until next milestone

Study Start

First participant enrolled

September 20, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

September 28, 2021

Status Verified

September 1, 2021

Enrollment Period

1.8 years

First QC Date

July 16, 2020

Last Update Submit

September 26, 2021

Conditions

Obstructive Sleep Apnea

Outcome Measures

Primary Outcomes (9)

  • Postoperative pain

    visual analog pain score

    Assessment will be carried out at zero time (time to shift to PACU) .

  • Postoperative pain

    Visual analog pain score

    Assessment will be carried out 6 hours postoperatively

  • Postoperative pain

    Visual analog pain score

    Assessment will be carried out 12 hours postoperatively

  • Postoperative pain

    Visual analog pain score

    Assessment will be carried out 18 hours postoperatively

  • Postoperative pain

    Visual analog pain score

    Assessment will be carried out 24 hours postoperatively

  • Postoperative pain

    Visual analog pain score

    Assessment will be carried out 30 hours postoperatively

  • Postoperative pain

    Visual analog pain score

    Assessment will be carried out 36 hours postoperatively

  • Postoperative pain

    Visual analog pain score

    Assessment will be carried out 42 hours postoperatively

  • Postoperative pain

    Visual analog pain score

    Assessment will be carried out 48 hours postoperatively

Secondary Outcomes (18)

  • Sedation level

    Zero time ( time to shift to PACU)

  • Sedation level

    6 hours postoperatively

  • Sedation level

    12 hours postoperatively

  • Sedation level

    18 hours postoperatively

  • Sedation level

    24 hours postoperatively

  • +13 more secondary outcomes

Study Arms (1)

OSA patients after multilevel surgery

EXPERIMENTAL
Combination Product: Nalbuphine, ketorolac, accufuser

Interventions

Nalbuphine, ketorolac, accufuserCOMBINATION_PRODUCT

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

OSA patients after multilevel surgery

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag faculty of medicine

Sohag, 82524, Egypt

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Interventions

NalbuphineKetorolac

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Intervention Hierarchy (Ancestors)

MorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsIndomethacinIndolesHeterocyclic Compounds, 2-Ring

Study Officials

  • Bahaa M Refaie, MD

    Lecturer of anesthesia and ICU sohag university

    PRINCIPAL INVESTIGATOR

  • Mohammed E Ahmed, MD

    Lecturer of ENT sohag university

    STUDY DIRECTOR

  • A M Elhalwagy, MD

    Consultant of pain medicine

    STUDY CHAIR

Central Study Contacts

Bahaa M Refaie, MD

CONTACT

0201026887257bahaarefaay@med.sohag.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer of anesthesia and ICU

Study Record Dates

First Submitted

July 16, 2020

First Posted

July 23, 2020

Study Start

September 20, 2020

Primary Completion

July 1, 2022

Study Completion

December 1, 2022

Last Updated

September 28, 2021

Record last verified: 2021-09

Locations

EG(1)