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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group C (control) | Experimental | subjects who will receive one capsule of placebo before the surgery and being repeated the next day |
|
| Group D (duloxetine) | Active Comparator | subjects who will receive one capsule of duloxetine 60 mg before the surgery and being repeated the next day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine | Drug | duloxetine 60 mg |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | up to 2 days. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28002096 | Result | 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. |
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The study was started in January, 2014 at the Centro Hospitalar Unimed of Joinville, Brazil
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| ID | Title | Description |
|---|---|---|
| FG000 | Group C (Control) | subjects who will receive one capsule of placebo before the surgery and being repeated the next day Placebo: placebo |
| FG001 | Group D (Duloxetine) | subjects who will receive one capsule of duloxetine 60 mg before the surgery and being repeated the next day Duloxetine: duloxetine 60 mg |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group C (Control) | subjects who will receive one capsule of placebo before the surgery and being repeated the next day Placebo: placebo |
| BG001 | Group D (Duloxetine) | subjects who will receive one capsule of duloxetine 60 mg before the surgery and being repeated the next day Duloxetine: duloxetine 60 mg |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | At the beginning of the trial, Group C would have 30 patients and D also 30 patients. However, 1 patient in Group C and 2 patients in group D were excluded due to cancellation of the proposed surgery, after patient receiving 60 mg of duloxetine. The lower the consumption of fentanyl, the better the analgesic effect of duloxetine. | Posted | Mean | Standard Deviation | micrograms | up to 2 days. |
|
Two days.
Incidence of adverse effects accessed in the first two postoperative days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group C (Control) | subjects who will receive one capsule of placebo before the surgery and being repeated the next day Placebo: placebo |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| somnolence | Nervous system disorders | Non-systematic Assessment |
We used the same dose as previous investigators. We did not evaluate a possible effect of duloxetine on chronic postsurgical pain.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Antonio Bedin | Serviço de Anestesiologia de Joinville | +554734331666 | abjoimailbox-ct@yahoo.com |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Placebo | Drug | placebo |
|
|
| up to 2 days. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| Group C (Control) |
subjects who will receive one capsule of placebo before the surgery and being repeated the next day Placebo: placebo |
| OG001 | Group D (Duloxetine) | subjects who will receive one capsule of duloxetine 60 mg before the surgery and being repeated the next day Duloxetine: duloxetine 60 mg |
|
|
| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | Number (pain score range 0 to 10). | up to 2 days. |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 10 |
| 29 |
| EG001 | Group D (Duloxetine) | subjects who will receive one capsule of duloxetine 60 mg before the surgery and being repeated the next day Duloxetine: duloxetine 60 mg | 0 | 28 | 0 | 28 | 9 | 28 |
| itching | General disorders | Non-systematic Assessment |
|
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
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| D006571 |
| Heterocyclic Compounds |
| Pain score 12 hours after surgery. |
|
| Pain score 24 hours after surgery. |
|
| Pain score 36 hours after surgery. |
|
| Pain score 48 hours after surgery. |
|