Effect of Buprenorphine/Naloxone Continuation on Pain Control and Opioid Use
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|ClinicalTrials.gov Identifier: NCT03266445|
Recruitment Status : Not yet recruiting
First Posted : August 30, 2017
Last Update Posted : October 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Opioid-use Disorder Pain, Acute Surgery||Drug: buprenorphine/naloxone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Participants will be randomly assigned to be maintained on their daily dose of buprenorphine/naloxone or to have their buprenorphine/naloxone reduced to 8mg prior to surgery. Each group will have identical perioperative treatment plans. Primary outcome measured is pain scores following surgery.|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Randomized Trial of the Effect of Standard of Care Reduced Dose Versus Full Dose Buprenorphine/Naloxone in the Perioperative Period on Pain Control and Post Operative Opioid Use Disorder Symptoms|
|Estimated Study Start Date :||October 5, 2018|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||February 26, 2022|
Active Comparator: FULL-BUPRENORPHINE
Participants will be randomly assigned to be maintained on their daily dose of buprenorphine/naloxone
The intervention will be to either continue taking buprenorphine/naloxone or to have the medication reduced perioperatively.
Other Name: Reduction vs Continuation
No Intervention: LOW-BUPRENORPHINE (control)
Participants will be randomly assigned to have their daily dose of buprenorphine/naloxone reduced to 8mg on the day of surgery
- Post-operative pain scores [ Time Frame: 24 hours after surgery ]Level of pain on a Visual Analog Scale of 0-100 (0=no pain; 100=worst pain imaginable) This scale will be used to quantify the varying degrees of pain or discomfort experienced by the participant.
- Postoperative opioid consumption [ Time Frame: 24 hours, 48 hours and 72 hours after surgery ]Amount of opioids needed for pain control postoperatively
- Post-operative pain scores [ Time Frame: 48 hours, 72 hours after surgery ]Level of pain on Visual Analog Scale 0-100 (0= no pain 100= worst pain imaginable) We will compare the results of the 48 and 72 hour time-points with the 24 hour time-point.
- Presence, severity of substance abuse [ Time Frame: 1 month after surgery ]Participants will complete questionnaires to identify the presence and severity of substance abuse.These values will be compared with baseline values obtained preoperatively.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03266445
|Contact: Aurora Quaye, MDfirstname.lastname@example.org|
|Principal Investigator:||Aurora Quaye, MD||Massachusetts General Hospital|