Clinical trial NCT04483427: Multimodal Postoperative Analgesia Following OSA Surgery
Official title: Multimodal Postoperative Analgesia Using Accufuser for Multilevel Surgery for Obstructive Sleep Apnea (OSA)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2020-07-23
Enrollment: 30
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative pain
timeFrame: Assessment will be carried out at zero time (time to shift to PACU) .
measure: Postoperative pain
timeFrame: Assessment will be carried out 6 hours postoperatively
measure: Postoperative pain
timeFrame: Assessment will be carried out 12 hours postoperatively
measure: Postoperative pain
timeFrame: Assessment will be carried out 18 hours postoperatively
measure: Postoperative pain
timeFrame: Assessment will be carried out 24 hours postoperatively
measure: Postoperative pain
timeFrame: Assessment will be carried out 30 hours postoperatively
measure: Postoperative pain
timeFrame: Assessment will be carried out 36 hours postoperatively
measure: Postoperative pain
timeFrame: Assessment will be carried out 42 hours postoperatively
measure: Postoperative pain
timeFrame: Assessment will be carried out 48 hours postoperatively
Secondary outcomes:
measure: Sedation level
timeFrame: Zero time ( time to shift to PACU)
measure: Sedation level
timeFrame: 6 hours postoperatively
measure: Sedation level
timeFrame: 12 hours postoperatively
measure: Sedation level
timeFrame: 18 hours postoperatively
measure: Sedation level
timeFrame: 24 hours postoperatively
measure: Sedation level
timeFrame: 30 hours postoperatively
measure: Sedation level
timeFrame: 36 hours postoperatively
measure: Sedation level
timeFrame: 42 hours postoperatively
measure: Sedation level
timeFrame: 48 hours postoperatively
measure: incidence of adverse effects
timeFrame: Zero time ( time to shift to PACU)
measure: incidence of adverse effects
timeFrame: 6 hours postoperatively
measure: incidence of adverse effects
timeFrame: 12 hours postoperatively
measure: incidence of adverse effects
timeFrame: 18 hours postoperatively
measure: incidence of adverse effects
timeFrame: 24 hours postoperatively
measure: incidence of adverse effects
timeFrame: 30 hours postoperatively
measure: incidence of adverse effects
timeFrame: 36 hours postoperatively
measure: incidence of adverse effects
timeFrame: 42 hours postoperatively
measure: incidence of adverse effects
timeFrame: 48 hours postoperatively
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag faculty of medicine
Study officials:
affiliation: Lecturer of anesthesia and ICU sohag university
name: Bahaa M Refaie, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer of ENT sohag university
name: Mohammed E Ahmed, MD
role: STUDY_DIRECTOR
affiliation: Consultant of pain medicine
name: A M Elhalwagy, MD
role: STUDY_CHAIR
References: