Intervertebral Disc Degeneration
Conditions
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.
Interventions
DRUGDuloxetine
duloxetine 60 mg
DRUGPlacebo
placebo
Sponsors
Serviço de Anestesiologia de Joinville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Consumption of Fentanyl (in Micrograms) Self-administered by the Patient and Accessed at 24 and 48 Hours After Spine Surgery. | up to 2 days. | 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
| Measure | Time frame | Description |
|---|---|---|
| Self Reported Pain Score Range From 0 (no Pain) to 10 (Worst Possible Pain). | up to 2 days. | 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. |
Participant flow
Recruitment details
The study was started in January, 2014 at the Centro Hospitalar Unimed of Joinville, Brazil
Participants by arm
| Arm | Count |
|---|---|
| Group C (Control) subjects who will receive one capsule of placebo before the surgery and being repeated the next day
Placebo: placebo | 29 |
| 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 | 28 |
| Total | 57 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Cancellation of surgery. | 1 | 2 |
Baseline characteristics
| Characteristic | Group D (Duloxetine) | Total | Group C (Control) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants | 57 Participants | 29 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Brazil | 28 participants | 57 participants | 29 participants |
| Sex: Female, Male Female | 15 Participants | 31 Participants | 16 Participants |
| Sex: Female, Male Male | 13 Participants | 26 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 28 |
| other Total, other adverse events | 10 / 29 | 9 / 28 |
| serious Total, serious adverse events | 0 / 29 | 0 / 28 |
Outcome results
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.
Time frame: up to 2 days.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group C (Control) | Total Consumption of Fentanyl (in Micrograms) Self-administered by the Patient and Accessed at 24 and 48 Hours After Spine Surgery. | Fentanyl consumption in between 0 and 24 hours. | 726 micrograms | Standard Deviation 36 |
| Group C (Control) | Total Consumption of Fentanyl (in Micrograms) Self-administered by the Patient and Accessed at 24 and 48 Hours After Spine Surgery. | Fentanyl consumption in between 24 and 48 hours. | 180 micrograms | Standard Deviation 20 |
| Group D (Duloxetine) | Total Consumption of Fentanyl (in Micrograms) Self-administered by the Patient and Accessed at 24 and 48 Hours After Spine Surgery. | Fentanyl consumption in between 0 and 24 hours. | 503 micrograms | Standard Deviation 19 |
| Group D (Duloxetine) | Total Consumption of Fentanyl (in Micrograms) Self-administered by the Patient and Accessed at 24 and 48 Hours After Spine Surgery. | Fentanyl consumption in between 24 and 48 hours. | 136 micrograms | Standard Deviation 13 |
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.
Time frame: up to 2 days.
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group C (Control) | Self Reported Pain Score Range From 0 (no Pain) to 10 (Worst Possible Pain). | Pain score 48 hours after surgery. | 1.51 Number (pain score range 0 to 10). | Standard Deviation 2.08 |
| Group C (Control) | Self Reported Pain Score Range From 0 (no Pain) to 10 (Worst Possible Pain). | Pain score 24 hours after surgery. | 1.68 Number (pain score range 0 to 10). | Standard Deviation 2.13 |
| Group C (Control) | Self Reported Pain Score Range From 0 (no Pain) to 10 (Worst Possible Pain). | Pain score 2 hours after surgery. | 2.27 Number (pain score range 0 to 10). | Standard Deviation 2.67 |
| Group C (Control) | Self Reported Pain Score Range From 0 (no Pain) to 10 (Worst Possible Pain). | pain score 6 hours after surgery | 2.67 Number (pain score range 0 to 10). | Standard Deviation 2.44 |
| Group C (Control) | Self Reported Pain Score Range From 0 (no Pain) to 10 (Worst Possible Pain). | Pain score 12 hours after surgery. | 2.10 Number (pain score range 0 to 10). | Standard Deviation 2.31 |
| Group C (Control) | Self Reported Pain Score Range From 0 (no Pain) to 10 (Worst Possible Pain). | Pain score 36 hours after surgery. | 1.48 Number (pain score range 0 to 10). | Standard Deviation 2.06 |
| Group D (Duloxetine) | Self Reported Pain Score Range From 0 (no Pain) to 10 (Worst Possible Pain). | Pain score 12 hours after surgery. | 2.07 Number (pain score range 0 to 10). | Standard Deviation 1.92 |
| Group D (Duloxetine) | Self Reported Pain Score Range From 0 (no Pain) to 10 (Worst Possible Pain). | pain score 6 hours after surgery | 2.28 Number (pain score range 0 to 10). | Standard Deviation 2.07 |
| Group D (Duloxetine) | Self Reported Pain Score Range From 0 (no Pain) to 10 (Worst Possible Pain). | Pain score 24 hours after surgery. | 1.66 Number (pain score range 0 to 10). | Standard Deviation 1.64 |
| Group D (Duloxetine) | Self Reported Pain Score Range From 0 (no Pain) to 10 (Worst Possible Pain). | Pain score 48 hours after surgery. | 1.07 Number (pain score range 0 to 10). | Standard Deviation 1.03 |
| Group D (Duloxetine) | Self Reported Pain Score Range From 0 (no Pain) to 10 (Worst Possible Pain). | Pain score 36 hours after surgery. | 1.37 Number (pain score range 0 to 10). | Standard Deviation 1.52 |
| Group D (Duloxetine) | Self Reported Pain Score Range From 0 (no Pain) to 10 (Worst Possible Pain). | Pain score 2 hours after surgery. | 2.14 Number (pain score range 0 to 10). | Standard Deviation 2.04 |