Post Operative Analgesia and Patient Satisfaction

Loma Linda University (LLU)

Status and phase: Completed; Phase 3

Conditions: Postoperative Pain; Patient Satisfaction; Analgesia

Treatments: Drug: Ibuprofen 600 mg; Drug: Acetaminophen 650 MG; Drug: Hydrocodone/Acetaminophen 5 Mg-325 Mg ORAL TABLET

Study type: Interventional

Funder types: Other

Identifiers

NCT04976387

52004443

Details and patient eligibility

About

To understand how patients perceive the quality of care they receive when given different post-operative analgesic medications. Specifically the investigators want to assess whether patients who receive non-opioid analgesia following surgery endorse appropriate quality and satisfaction with their care compared to those who receive opioid medication.

Full description

It is routine practice to give analgesic medication after any surgical procedure to provide adequate pain control for patients. However with the increase in abuse of opioid prescription medications, physicians have given a new emphasis to different pain regimens that aim to limit the use of opioid medications. The investigator's previous clinical trial demonstrated that for patients undergoing outpatient otolaryngology procedures, not only does Ibuprofen provide equally effective analgesia compared to opioid medication but it can also decrease overall opioid requirement.

In the current proposed study, the investigators wish to build on previous work. The investigators hypothesize that with the addition of Acetaminophen to Ibuprofen, patients undergoing outpatient otolaryngology procedures may not require opioid analgesia at all. While numerous studies corroborate these results, there is little information about patients' satisfaction with their care in light of a shifting emphasis on decreasing opioid prescription. The primary goal of the current study is to better understand patients' perception of care and level of satisfaction when given opioid versus non-opioid postoperative analgesia. If there is conflicting data with regards to patients reporting adequate pain control but poor satisfaction, then perhaps further public health intervention may be necessary to provide additional patient education to help re-establish appropriate and safe patient expectations for postsurgical analgesia.

Enrollment: 150 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients between the ages of 18 and 89 years of age

• Patients undergoing the following outpatient procedures at a LLUHS associated surgical facility:

  • total or partial thyroidectomy
  • parathyroidectomy
  • parotidectomy
  • submandibular gland excision
  • neck mass excision
  • facial mass excision
  • MOHS defect repair
  • excision of cutaneous lesions
  • Other surgeries may qualify and will be assessed on a case by case basis.

Exclusion criteria

• Patients under 18 years old or older than 89 years old
• Those allergic to Hydrocodone, Acetaminophen, or NSAIDS
• Patients who are pregnant
• Patients with chronic medical conditions including hepatic/renal disease that precludes their ability to utilize the study medications.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

150 participants in 3 patient groups

Group 1: Hydrocodone/Acetaminophen and Ibuprofen

Experimental group

Description:

This group will take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for pain control If pain is not controlled after 60 minutes then can take Ibuprofen 600mg every 6 hours as needed for additional pain control.

Treatment:

Drug: Hydrocodone/Acetaminophen 5 Mg-325 Mg ORAL TABLET

Drug: Ibuprofen 600 mg

Group 2: Ibuprofen and Hydrocodone/acetaminophen

Experimental group

Description:

This group will take Ibuprofen 600mg every 6 hours as needed for pain control If pain is not controlled after 60 minutes then can take Hydrocodone/acetaminophen 5mg/325mg every 6 hours as needed for additional pain control.

Treatment:

Drug: Hydrocodone/Acetaminophen 5 Mg-325 Mg ORAL TABLET

Drug: Ibuprofen 600 mg

Group 3: Ibuprofen and Acetaminophen

Experimental group

Description:

This group will take Ibuprofen 600mg every 6 hours as needed for pain control If pain is not controlled after 60 minutes then can take Acetaminophen 650mg every 6 hours as needed for additional pain control.

Treatment:

Drug: Acetaminophen 650 MG

Drug: Ibuprofen 600 mg