Duloxetine as an Analgesic Agent in Patients Undergoing Elective Spine Surgery (Duloxetine)
Primary Purpose
Intervertebral Disc Degeneration
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Duloxetine
Placebo
Sponsored by
About this trial
This is an interventional supportive care trial for Intervertebral Disc Degeneration
Eligibility Criteria
Inclusion Criteria:
- Patients were included, of both genders, aged between 18 and 70 years and American Society of Anesthesiologists (ASA) physical status 1-3 and were eligible for the study
Exclusion Criteria:
- Patients allergics to duloxetine, ketoralac or fentanyl, pre-existing history of use of illegal substances or alcohol in an abusive manner and abnormal kidney or liver function tests.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Group C (control)
Group D (duloxetine)
Arm Description
subjects who will receive one capsule of placebo before the surgery and being repeated the next day
subjects who will receive one capsule of duloxetine 60 mg before the surgery and being repeated the next day
Outcomes
Primary Outcome Measures
Total Consumption of Fentanyl (in Micrograms) Self-administered by the Patient and Accessed at 24 and 48 Hours After Spine Surgery.
The main evaluation parameter was the total consumption of fentanyl (in micrograms) self-administered by the patient and accessed at 24 and 48 hours after surgery. At the beginning of the study, Group C (placebo) would have 30 patients and D (duloxetine) would also have 30 patients. However, 1 patient in Group C and 2 patients in Group D were excluded due to the cancellation of the proposed surgery, after the patient had received 60 milligrams of duloxetine. The lower the consumption of fentanyl, the better the analgesic effect of duloxetine.
Secondary Outcome Measures
Self Reported Pain Score Range From 0 (no Pain) to 10 (Worst Possible Pain).
At the beginning of the study, Group C (placebo) would have 30 patients and D (duloxetine) would also have 30 patients. However, 1 patient in Group C and 2 patients in Group D were excluded due to the cancellation of the proposed surgery, after the patient had received 60 milligrams of duloxetine. Self reported pain score range from 0 (no pain) to 10 (worst possible pain) 2, 6, 12, 24, 36 and 48 hours after surgery. Higher scores mean a worse score and low scores mean a better score.
Full Information
NCT ID
NCT02535000
First Posted
August 23, 2015
Last Updated
September 13, 2020
Sponsor
Serviço de Anestesiologia de Joinville
1. Study Identification
Unique Protocol Identification Number
NCT02535000
Brief Title
Duloxetine as an Analgesic Agent in Patients Undergoing Elective Spine Surgery
Acronym
Duloxetine
Official Title
Duloxetine as an Analgesic Agent in Patients Undergoing Elective Spine Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2014 (Actual)
Primary Completion Date
October 20, 2015 (Actual)
Study Completion Date
October 30, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Serviço de Anestesiologia de Joinville
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Duloxetine as an analgesic agent in patients undergoing elective spine surgery: evaluation with fentanyl demand controlled by the patient. The primary objective is to evaluate the efficacy of duloxetine in fentanyl consumption during the postoperative period of patients undergoing elective spine surgery by intervertebral disc degeneration . Secondary endpoints were pain scores and the presence or absence of adverse effects such as headache, nausea, vomiting, itching, dizziness and drowsiness.
Detailed Description
Multimodal analgesia is widely advocated for the control of perioperative pain in an attempt to reduce the use of opioids and their side effects. Duloxetine is a selective inhibitor of serotonin and norepinephrine reuptake with demonstrated efficacy in chronic pain such as painful diabetic neuropathy and postherpetic neuralgia. The primary objective is to evaluate the efficacy of duloxetine in fentanyl consumption during the postoperative period of patients undergoing elective spine surgery by intervertebral disc degeneration . Duloxetine as an analgesic agent in patients undergoing elective spine surgery: evaluation with fentanyl demand controlled by the patient. The primary objective is to evaluate the efficacy of duloxetine in fentanyl consumption during the postoperative period of patients undergoing elective spine surgery by degenerative disc disease. Secondary endpoints were pain scores and the presence or absence of adverse effects such as headache, nausea, vomiting, itching, dizziness and drowsiness.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intervertebral Disc Degeneration
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group C (control)
Arm Type
Experimental
Arm Description
subjects who will receive one capsule of placebo before the surgery and being repeated the next day
Arm Title
Group D (duloxetine)
Arm Type
Active Comparator
Arm Description
subjects who will receive one capsule of duloxetine 60 mg before the surgery and being repeated the next day
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Other Intervention Name(s)
Cymbalta
Intervention Description
duloxetine 60 mg
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
inactive substance
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Total Consumption of Fentanyl (in Micrograms) Self-administered by the Patient and Accessed at 24 and 48 Hours After Spine Surgery.
Description
The main evaluation parameter was the total consumption of fentanyl (in micrograms) self-administered by the patient and accessed at 24 and 48 hours after surgery. At the beginning of the study, Group C (placebo) would have 30 patients and D (duloxetine) would also have 30 patients. However, 1 patient in Group C and 2 patients in Group D were excluded due to the cancellation of the proposed surgery, after the patient had received 60 milligrams of duloxetine. The lower the consumption of fentanyl, the better the analgesic effect of duloxetine.
Time Frame
up to 2 days.
Secondary Outcome Measure Information:
Title
Self Reported Pain Score Range From 0 (no Pain) to 10 (Worst Possible Pain).
Description
At the beginning of the study, Group C (placebo) would have 30 patients and D (duloxetine) would also have 30 patients. However, 1 patient in Group C and 2 patients in Group D were excluded due to the cancellation of the proposed surgery, after the patient had received 60 milligrams of duloxetine. Self reported pain score range from 0 (no pain) to 10 (worst possible pain) 2, 6, 12, 24, 36 and 48 hours after surgery. Higher scores mean a worse score and low scores mean a better score.
Time Frame
up to 2 days.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients were included, of both genders, aged between 18 and 70 years and American Society of Anesthesiologists (ASA) physical status 1-3 and were eligible for the study
Exclusion Criteria:
Patients allergics to duloxetine, ketoralac or fentanyl, pre-existing history of use of illegal substances or alcohol in an abusive manner and abnormal kidney or liver function tests.
12. IPD Sharing Statement
Citations:
PubMed Identifier
28002096
Citation
Bedin A, Caldart Bedin RA, Vieira JE, Ashmawi HA. Duloxetine as an Analgesic Reduces Opioid Consumption After Spine Surgery: A Randomized, Double-Blind, Controlled Study. Clin J Pain. 2017 Oct;33(10):865-869. doi: 10.1097/AJP.0000000000000471.
Results Reference
result
Learn more about this trial
Duloxetine as an Analgesic Agent in Patients Undergoing Elective Spine Surgery
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