Multimodal Postoperative Analgesia Following OSA Surgery

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04483427
• Other study ID #: 1984
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2020
• Est. completion date: December 2022

Study information

• Verified date: September 2021
• Source: Sohag University
• Contact: Bahaa M Refaie, MD
• Phone: 0201026887257
• Email: bahaarefaay[@]med.sohag.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Combination Product:
• Nalbuphine, ketorolac, accufuser
multimodal analgesic regimen consisting of nalbuphine combined with ketorolac using IV continuous infusion silicon device (Accufuser)

Locations

Country	Name	City	State
Egypt	Sohag faculty of medicine	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Bahaa Mohammed Refaie

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain	visual analog pain score	Assessment will be carried out at zero time (time to shift to PACU) .
Primary	Postoperative pain	Visual analog pain score	Assessment will be carried out 6 hours postoperatively
Primary	Postoperative pain	Visual analog pain score	Assessment will be carried out 12 hours postoperatively
Primary	Postoperative pain	Visual analog pain score	Assessment will be carried out 18 hours postoperatively
Primary	Postoperative pain	Visual analog pain score	Assessment will be carried out 24 hours postoperatively
Primary	Postoperative pain	Visual analog pain score	Assessment will be carried out 30 hours postoperatively
Primary	Postoperative pain	Visual analog pain score	Assessment will be carried out 36 hours postoperatively
Primary	Postoperative pain	Visual analog pain score	Assessment will be carried out 42 hours postoperatively
Primary	Postoperative pain	Visual analog pain score	Assessment will be carried out 48 hours postoperatively
Secondary	Sedation level	Ramsey sedation scale	Zero time ( time to shift to PACU)
Secondary	Sedation level	Ramsey sedation scale	6 hours postoperatively
Secondary	Sedation level	Ramsey Sedation Scale	12 hours postoperatively
Secondary	Sedation level	Ramsey Sedation Scale	18 hours postoperatively
Secondary	Sedation level	Ramsey Sedation Scale	24 hours postoperatively
Secondary	Sedation level	Ramsey Sedation scale	30 hours postoperatively
Secondary	Sedation level	Ramsey Sedation Scale	36 hours postoperatively
Secondary	Sedation level	Ramsey Sedation Scale	42 hours postoperatively
Secondary	Sedation level	Ramsey Sedation Ramsey Sedation Scale	48 hours postoperatively
Secondary	incidence of adverse effects	hypoxia, nausea, vomiting, itching	Zero time ( time to shift to PACU)
Secondary	incidence of adverse effects	hypoxia, nausea, vomiting, itching	6 hours postoperatively
Secondary	incidence of adverse effects	hypoxia, nausea, vomiting, itching	12 hours postoperatively
Secondary	incidence of adverse effects	hypoxia, nausea, vomiting, itching	18 hours postoperatively
Secondary	incidence of adverse effects	hypoxia, nausea, vomiting, itching	24 hours postoperatively
Secondary	incidence of adverse effects	hypoxia, nausea, vomiting, itching	30 hours postoperatively
Secondary	incidence of adverse effects	hypoxia, nausea, vomiting, itching	36 hours postoperatively
Secondary	incidence of adverse effects	hypoxia, nausea, vomiting, itching	42 hours postoperatively
Secondary	incidence of adverse effects	hypoxia, nausea, vomiting, itching	48 hours postoperatively