Multimodal Postoperative Analgesia Following OSA Surgery

Study Overview
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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

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

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Combination Product: Nalbuphine, ketorolac, accufuser


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OSA patients after multilevel surgery<br> | Combination Product: Nalbuphine, ketorolac, accufuser<br>* multimodal analgesic regimen consisting of nalbuphine combined with ketorolac using IV continuous infusion silicon device (Accufuser)<br>|

What is the study measuring?
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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 |