Trial Outcomes & Findings for Oral Pregabalin as Preemptive Analgesia in Abdominal Hysterectomy (NCT NCT04495374)
NCT ID: NCT04495374
Last Updated: 2021-03-04
Results Overview
Postoperative pain assessment, 24 hours after abdominal hysterectomy surgery, in patients who used a single dose of pregabalin 300mg or placebo as preemptive analgesia, using the visual analog scale (VAS) consisting of a 10 cm (cm) line ) graduated in natural number intervals, starting at 0 (zero) until reaching 10 (ten), associated with the numbers, drawings related to the pain presented by the patient at the moment, in which the absence of pain (0 ) there is a happy face, and as the numerical value increases, the drawn face will represent the intensity of pain, up to the value of 10, where a face with crying characteristics is found, indicating greater pain.
TERMINATED
PHASE4
58 participants
End of the first postoperative day of abdominal hysterectomy surgery (24 hours after the end of surgery)
2021-03-04
Participant Flow
Participant milestones
| Measure |
Group P(0) - Placebo
Patients were randomly allocated to Group P(0) - Placebo by a double blind randomized study. Group P(0) received two placebo tablets as medication, 02h before the start of the anesthesic-surgical procedure in identical sealed envelops, only identified as medication A or B
Placebo: Group P0 will receive a placebo tablet, 02h before the surgical procedure
|
Group P(1) - Pregabalin 300mg
Patients were randomly allocated to Group P(1) - Pregabalin 300mg by a double blind randomized study. Group P(1) received two tablets of pregabalin 150mg, 02h before the start of the anesthesic-surgical procedure in identical sealed envelops, only identified as medication A or B
Pregabalin 300mg: Group P1 will receive a 300 mg tablet of pregabalin, 02h before the surgical procedure
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
28
|
|
Overall Study
COMPLETED
|
28
|
27
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
Group P(0) - Placebo
Patients were randomly allocated to Group P(0) - Placebo by a double blind randomized study. Group P(0) received two placebo tablets as medication, 02h before the start of the anesthesic-surgical procedure in identical sealed envelops, only identified as medication A or B
Placebo: Group P0 will receive a placebo tablet, 02h before the surgical procedure
|
Group P(1) - Pregabalin 300mg
Patients were randomly allocated to Group P(1) - Pregabalin 300mg by a double blind randomized study. Group P(1) received two tablets of pregabalin 150mg, 02h before the start of the anesthesic-surgical procedure in identical sealed envelops, only identified as medication A or B
Pregabalin 300mg: Group P1 will receive a 300 mg tablet of pregabalin, 02h before the surgical procedure
|
|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
1
|
Baseline Characteristics
Oral Pregabalin as Preemptive Analgesia in Abdominal Hysterectomy
Baseline characteristics by cohort
| Measure |
Group P(0) - Placebo
n=28 Participants
Patients were randomly allocated to Group P(0) - Placebo by a double blind randomized study. Group P(0) received two placebo tablets as medication, 02h before the start of the anesthesic-surgical procedure in identical sealed envelops, only identified as medication A or B
Placebo: Group P0 will receive a placebo tablet, 02h before the surgical procedure
|
Group P(1) - Pregabalin 300mg
n=27 Participants
Patients were randomly allocated to Group P(1) - Pregabalin 300mg by a double blind randomized study. Group P(1) received two tablets of pregabalin 150mg, 02h before the start of the anesthesic-surgical procedure in identical sealed envelops, only identified as medication A or B
Pregabalin 300mg: Group P1 will receive a 300 mg tablet of pregabalin, 02h before the surgical procedure
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
41.5 years
STANDARD_DEVIATION 7.86 • n=5 Participants
|
45 years
STANDARD_DEVIATION 4.15 • n=7 Participants
|
43 years
STANDARD_DEVIATION 6.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · White
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Black
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Brown
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: End of the first postoperative day of abdominal hysterectomy surgery (24 hours after the end of surgery)Postoperative pain assessment, 24 hours after abdominal hysterectomy surgery, in patients who used a single dose of pregabalin 300mg or placebo as preemptive analgesia, using the visual analog scale (VAS) consisting of a 10 cm (cm) line ) graduated in natural number intervals, starting at 0 (zero) until reaching 10 (ten), associated with the numbers, drawings related to the pain presented by the patient at the moment, in which the absence of pain (0 ) there is a happy face, and as the numerical value increases, the drawn face will represent the intensity of pain, up to the value of 10, where a face with crying characteristics is found, indicating greater pain.
Outcome measures
| Measure |
Group P(0) - Placebo
n=28 Participants
Patients were randomly allocated to Group P(0) - Placebo by a double blind randomized study. Group P(0) received two placebo tablets as medication, 02h before the start of the anesthesic-surgical procedure in identical sealed envelops, only identified as medication A or B
Placebo: Group P0 will receive a placebo tablet, 02h before the surgical procedure
|
Group P(1) - Pregabalin 300mg
n=27 Participants
Patients were randomly allocated to Group P(1) - Pregabalin 300mg by a double blind randomized study. Group P(1) received two tablets of pregabalin 150mg, 02h before the start of the anesthesic-surgical procedure in identical sealed envelops, only identified as medication A or B
Pregabalin 300mg: Group P1 will receive a 300 mg tablet of pregabalin, 02h before the surgical procedure
|
|---|---|---|
|
Postoperative Pain in Rest Assessed 24 Hours After Abdominal Hysterectomy Surgery Using the Visual Analog Scale (VAS)
|
5 score on a scale
Standard Deviation 1.34
|
2 score on a scale
Standard Deviation 1.19
|
PRIMARY outcome
Timeframe: End of the first postoperative day of abdominal hysterectomy surgery (24 hours after the end of surgery)Postoperative pain assessment, 24 hours after abdominal hysterectomy surgery, in patients who used a single 300mg dose of pregabalin or placebo as preemptive analgesia, using the McGill pain questionnaire, which consists of 20 word groups , and each group can contain from 2 to 6 descriptive words, these descriptors are placed in an increasing order of magnitude in relation to the intensity. The left of each word has a numerical value in an attempt to represent the intensity of the descriptor. For the analysis of the answers, the total number of words chosen in each subgroup by the patient was used to qualify his pain, the minimum value being equal to 0 (zero), if the patient chose not to choose any descriptor, and the maximum value would be 20, as the patient can choose only one descriptor for each subgroup. The quantitative pain index was also evaluated, which represents the sum of the values of each descriptor chosen by the patient, with a minimum value of 0 and a maximum of 78.
Outcome measures
| Measure |
Group P(0) - Placebo
n=28 Participants
Patients were randomly allocated to Group P(0) - Placebo by a double blind randomized study. Group P(0) received two placebo tablets as medication, 02h before the start of the anesthesic-surgical procedure in identical sealed envelops, only identified as medication A or B
Placebo: Group P0 will receive a placebo tablet, 02h before the surgical procedure
|
Group P(1) - Pregabalin 300mg
n=27 Participants
Patients were randomly allocated to Group P(1) - Pregabalin 300mg by a double blind randomized study. Group P(1) received two tablets of pregabalin 150mg, 02h before the start of the anesthesic-surgical procedure in identical sealed envelops, only identified as medication A or B
Pregabalin 300mg: Group P1 will receive a 300 mg tablet of pregabalin, 02h before the surgical procedure
|
|---|---|---|
|
Postoperative Pain Assessed 24 Hours After Abdominal Hysterectomy Surgery, Using the McGill Pain Questionnaire
|
28.5 score on a scale
Standard Deviation 11
|
12 score on a scale
Standard Deviation 10
|
PRIMARY outcome
Timeframe: End of the first postoperative day of abdominal hysterectomy surgery (24 hours after the end of surgery)Postoperative pain assessment, 24 hours after abdominal hysterectomy surgery, in patients who used a single dose of pregabalin 300mg or placebo as preemptive analgesia, using the visual analog scale (VAS) consisting of a 10 cm (cm) line ) graduated in natural number intervals, starting at 0 (zero) until reaching 10 (ten), associated with the numbers, drawings related to the pain presented by the patient at the moment, in which the absence of pain (0 ) there is a happy face, and as the numerical value increases, the drawn face will represent the intensity of pain, up to the value of 10, where a face with crying characteristics is found, indicating greater pain.
Outcome measures
| Measure |
Group P(0) - Placebo
n=28 Participants
Patients were randomly allocated to Group P(0) - Placebo by a double blind randomized study. Group P(0) received two placebo tablets as medication, 02h before the start of the anesthesic-surgical procedure in identical sealed envelops, only identified as medication A or B
Placebo: Group P0 will receive a placebo tablet, 02h before the surgical procedure
|
Group P(1) - Pregabalin 300mg
n=27 Participants
Patients were randomly allocated to Group P(1) - Pregabalin 300mg by a double blind randomized study. Group P(1) received two tablets of pregabalin 150mg, 02h before the start of the anesthesic-surgical procedure in identical sealed envelops, only identified as medication A or B
Pregabalin 300mg: Group P1 will receive a 300 mg tablet of pregabalin, 02h before the surgical procedure
|
|---|---|---|
|
Postoperative Pain in Active Movement Assessed 24 Hours After Abdominal Hysterectomy Surgery Using the Visual Analog Scale (VAS)
|
7 score on a scale
Standard Deviation 1.41
|
4 score on a scale
Standard Deviation 1.39
|
SECONDARY outcome
Timeframe: End of the first postoperative day of abdominal hysterectomy surgery (24 hours after the end of surgery)Evaluation of the number of intravenous opioid doses used within 24 hours of postoperative abdominal hysterectomy surgery in patients who used pregabalin 300mg or not as preemptive analgesia
Outcome measures
| Measure |
Group P(0) - Placebo
n=28 Participants
Patients were randomly allocated to Group P(0) - Placebo by a double blind randomized study. Group P(0) received two placebo tablets as medication, 02h before the start of the anesthesic-surgical procedure in identical sealed envelops, only identified as medication A or B
Placebo: Group P0 will receive a placebo tablet, 02h before the surgical procedure
|
Group P(1) - Pregabalin 300mg
n=27 Participants
Patients were randomly allocated to Group P(1) - Pregabalin 300mg by a double blind randomized study. Group P(1) received two tablets of pregabalin 150mg, 02h before the start of the anesthesic-surgical procedure in identical sealed envelops, only identified as medication A or B
Pregabalin 300mg: Group P1 will receive a 300 mg tablet of pregabalin, 02h before the surgical procedure
|
|---|---|---|
|
Number of Doses of Opioids Used as Analgesic Rescue in the Postoperative Period
|
4 number of doses
Standard Deviation 1.91
|
2 number of doses
Standard Deviation 1.27
|
SECONDARY outcome
Timeframe: End of the first postoperative day of abdominal hysterectomy surgery (24 hours after the end of surgery)• Evaluation of the time between the end of abdominal hysterectomy surgery and the patient's request for the use of the first dose of intravenous opioid as an analgesic rescue, comparing between patients who used or not pregabalin 300mg as preemptive analgesia
Outcome measures
| Measure |
Group P(0) - Placebo
n=28 Participants
Patients were randomly allocated to Group P(0) - Placebo by a double blind randomized study. Group P(0) received two placebo tablets as medication, 02h before the start of the anesthesic-surgical procedure in identical sealed envelops, only identified as medication A or B
Placebo: Group P0 will receive a placebo tablet, 02h before the surgical procedure
|
Group P(1) - Pregabalin 300mg
n=27 Participants
Patients were randomly allocated to Group P(1) - Pregabalin 300mg by a double blind randomized study. Group P(1) received two tablets of pregabalin 150mg, 02h before the start of the anesthesic-surgical procedure in identical sealed envelops, only identified as medication A or B
Pregabalin 300mg: Group P1 will receive a 300 mg tablet of pregabalin, 02h before the surgical procedure
|
|---|---|---|
|
Time Required for the Use of the First Dose of Opioid as an Analgesic Rescue in the Postoperative Period
|
170 Time in minutes
Standard Deviation 177.6
|
106 Time in minutes
Standard Deviation 64.8
|
SECONDARY outcome
Timeframe: End of the first postoperative day of abdominal hysterectomy surgery (24 hours after the end of surgery) and also immediately in the post-anesthetic recovery room• Assess the presence of adverse effects such as nausea and vomiting, itching and dizziness, comparing the intervention group that used pregabalin with the placebo group
Outcome measures
| Measure |
Group P(0) - Placebo
n=28 Participants
Patients were randomly allocated to Group P(0) - Placebo by a double blind randomized study. Group P(0) received two placebo tablets as medication, 02h before the start of the anesthesic-surgical procedure in identical sealed envelops, only identified as medication A or B
Placebo: Group P0 will receive a placebo tablet, 02h before the surgical procedure
|
Group P(1) - Pregabalin 300mg
n=27 Participants
Patients were randomly allocated to Group P(1) - Pregabalin 300mg by a double blind randomized study. Group P(1) received two tablets of pregabalin 150mg, 02h before the start of the anesthesic-surgical procedure in identical sealed envelops, only identified as medication A or B
Pregabalin 300mg: Group P1 will receive a 300 mg tablet of pregabalin, 02h before the surgical procedure
|
|---|---|---|
|
Number of Participants With Dizziness Between the Intervention and Control Groups
|
7 Participants
|
16 Participants
|
Adverse Events
Group P(0) - Placebo
Group P(1) - Pregabalin 300mg
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group P(0) - Placebo
n=28 participants at risk
Patients were randomly allocated to Group P(0) - Placebo by a double blind randomized study. Group P(0) received two placebo tablets as medication, 02h before the start of the anesthesic-surgical procedure in identical sealed envelops, only identified as medication A or B
Placebo: Group P0 will receive a placebo tablet, 02h before the surgical procedure
|
Group P(1) - Pregabalin 300mg
n=27 participants at risk
Patients were randomly allocated to Group P(1) - Pregabalin 300mg by a double blind randomized study. Group P(1) received two tablets of pregabalin 150mg, 02h before the start of the anesthesic-surgical procedure in identical sealed envelops, only identified as medication A or B
Pregabalin 300mg: Group P1 will receive a 300 mg tablet of pregabalin, 02h before the surgical procedure
|
|---|---|---|
|
Nervous system disorders
Dizziness
|
25.0%
7/28 • Data related to adverse events were collected during the follow-up of patients from the preoperative period up to 24h postoperatively.
Adverse events such as nausea and vomiting, pruritus, dizziness were evaluated during the entire follow-up of patients
|
59.3%
16/27 • Data related to adverse events were collected during the follow-up of patients from the preoperative period up to 24h postoperatively.
Adverse events such as nausea and vomiting, pruritus, dizziness were evaluated during the entire follow-up of patients
|
|
Gastrointestinal disorders
Nausea and vomiting
|
67.9%
19/28 • Data related to adverse events were collected during the follow-up of patients from the preoperative period up to 24h postoperatively.
Adverse events such as nausea and vomiting, pruritus, dizziness were evaluated during the entire follow-up of patients
|
59.3%
16/27 • Data related to adverse events were collected during the follow-up of patients from the preoperative period up to 24h postoperatively.
Adverse events such as nausea and vomiting, pruritus, dizziness were evaluated during the entire follow-up of patients
|
|
General disorders
Pruritus
|
3.6%
1/28 • Data related to adverse events were collected during the follow-up of patients from the preoperative period up to 24h postoperatively.
Adverse events such as nausea and vomiting, pruritus, dizziness were evaluated during the entire follow-up of patients
|
7.4%
2/27 • Data related to adverse events were collected during the follow-up of patients from the preoperative period up to 24h postoperatively.
Adverse events such as nausea and vomiting, pruritus, dizziness were evaluated during the entire follow-up of patients
|
Additional Information
Profa. Dra. Larissa Helena Lobos Torres Pacheco
Universidade Federal de Alfenas
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place