Multimodal Postoperative Analgesia Following OSA Surgery

Multimodal Postoperative Analgesia Using Accufuser for Multilevel Surgery for Obstructive Sleep Apnea (OSA)

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

Study Overview

• Status: Recruiting
• Conditions: Obstructive Sleep Apnea
• Intervention / Treatment: Combination product: Nalbuphine, ketorolac, accufuser

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bahaa M Refaie, MD; Phone Number: 0201026887257; Email: bahaarefaay@med.sohag.edu.eg

Study Locations

• Egypt
  • Sohag, Egypt, 82524
    • Recruiting
    • Sohag Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OSA patients after multilevel surgery	Combination product: Nalbuphine, ketorolac, accufuser; multimodal analgesic regimen consisting of nalbuphine combined with ketorolac using IV continuous infusion silicon device (Accufuser)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedation level	Ramsey sedation scale	Zero time ( time to shift to PACU)
Sedation level	Ramsey sedation scale	6 hours postoperatively
Sedation level	Ramsey Sedation Scale	12 hours postoperatively
Sedation level	Ramsey Sedation Scale	18 hours postoperatively
Sedation level	Ramsey Sedation Scale	24 hours postoperatively
Sedation level	Ramsey Sedation scale	30 hours postoperatively
Sedation level	Ramsey Sedation Scale	36 hours postoperatively
Sedation level	Ramsey Sedation Scale	42 hours postoperatively
Sedation level	Ramsey Sedation Ramsey Sedation Scale	48 hours postoperatively
incidence of adverse effects	hypoxia, nausea, vomiting, itching	Zero time ( time to shift to PACU)
incidence of adverse effects	hypoxia, nausea, vomiting, itching	6 hours postoperatively
incidence of adverse effects	hypoxia, nausea, vomiting, itching	12 hours postoperatively
incidence of adverse effects	hypoxia, nausea, vomiting, itching	18 hours postoperatively
incidence of adverse effects	hypoxia, nausea, vomiting, itching	24 hours postoperatively
incidence of adverse effects	hypoxia, nausea, vomiting, itching	30 hours postoperatively
incidence of adverse effects	hypoxia, nausea, vomiting, itching	36 hours postoperatively
incidence of adverse effects	hypoxia, nausea, vomiting, itching	42 hours postoperatively
incidence of adverse effects	hypoxia, nausea, vomiting, itching	48 hours postoperatively

Collaborators and Investigators

• Sponsor: Bahaa Mohammed Refaie
• Investigators: Principal Investigator: Bahaa M Refaie, MD, Lecturer of anesthesia and ICU sohag university; Study Director: Mohammed E Ahmed, MD, Lecturer of ENT sohag university; Study Chair: A M Elhalwagy, MD, Consultant of pain medicine

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2020
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: July 16, 2020
• First Submitted That Met QC Criteria: July 20, 2020
• First Posted (Actual): July 23, 2020

Study Record Updates

• Last Update Posted (Actual): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 26, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Analgesics, Opioid; Narcotics; Ketorolac; Nalbuphine
• Other Study ID Numbers: 1984

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No