Pain, Postoperative
Conditions
Keywords
mastectomy, pain, postoperative, pregabalin
Brief summary
The investigators hypothesize that pregabalin will decrease post-operative pain scores and analgesic use following total mastectomy compared to placebo. The primary outcome will be acute postoperative pain, measured by a verbal numerical rating score (VNRS) and total analgesic consumption during postoperative 48 hours. The secondary outcome will be VNRS at 1 week and 1 month after operation.
Interventions
DRUGPregabalin
Pregabalin 75 mg orally
Vitamin Complex orally
Sponsors
Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 69 Years
Healthy volunteers
No
Inclusion criteria
1. American Society of Anesthesia physical status class I & II 2. Age \> 20 and \< 70 years 3. Robot- assisted endoscopic thyroidectomy
Exclusion criteria
1. Known or suspected allergy, sensitivity, or contraindication to pregabalin or any of the standardized medications 2. Body mass index ≥ 40 kg/m2 3. History of seizure disorder 4. Current therapy with pregabalin, gabapentin, or any opioid 5. Any other physical or psychiatric condition which may impair their ability to cooperate with post-operative study data collection 6. Insulin-dependent diabetes mellitus 7. Renal insufficiency (estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores (Verbal Numerical Rating Scale;VNRS) During Postoperative Hours. | 1, 6, 24, 48 hour | Pain was evaluated using an 11-point verbal numerical rating scale (VNRS). Patients were instructed preoperatively to express their pain on the 0-10 VNRS, where 0 represents no pain at all and 10 represents the worst pain imaginable. |
| Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. | 1, 6, 24, 48 hour | Nausea and vomiting was graded on a four-point scale, where 0 = no nausea, 1 = mild nausea, 2 = severe nausea requiring antiemetics, and 3 = retching and/ or vomiting. Grades 3 and 4 were grouped together as postoperative nausea and vomiting (PONV) and rescue anti-emetic, metoclopramide 10 mg i.v. was given. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores (VNRS) at 1 Week and 1 Month After Operation | 1 week, 1 month | Pain was evaluated using an 11-point verbal numerical rating scale (VNRS). Patients were instructed preoperatively to express their pain on the 0-10 VNRS, where 0 represents no pain at all and 10 represents the worst pain imaginable. |
Countries
South Korea
Participant flow
Recruitment details
This study was approved by the Institutional Ethics Committee of Yonsei University Medical Center. Datas were collected between June and December 2009.
Pre-assignment details
Of a total of 78 patients assessed for eligibility, 70 subjects received pregabalin or placebo after randomization. Eight patients were excluded because some patients refused to participate and some patients have psychiatric disorder and insulin-dependent DM.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later | 35 |
| Pregabalin Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later | 35 |
| Total | 70 |
Baseline characteristics
| Characteristic | Pregabalin | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 1 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants | 34 Participants | 67 Participants |
| Age Continuous | 51 years STANDARD_DEVIATION 9 | 49 years STANDARD_DEVIATION 8 | 50 years STANDARD_DEVIATION 8 |
| Region of Enrollment Korea, Republic of | 35 participants | 35 participants | 70 participants |
| Sex: Female, Male Female | 35 Participants | 35 Participants | 70 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / 35 | 19 / 35 |
| serious Total, serious adverse events | 0 / 35 | 0 / 35 |
Outcome results
Primary
Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc.
Nausea and vomiting was graded on a four-point scale, where 0 = no nausea, 1 = mild nausea, 2 = severe nausea requiring antiemetics, and 3 = retching and/ or vomiting. Grades 3 and 4 were grouped together as postoperative nausea and vomiting (PONV) and rescue anti-emetic, metoclopramide 10 mg i.v. was given.
Time frame: 1, 6, 24, 48 hour
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. | PONV | 4 participants |
| Placebo | Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. | sedation | 8 participants |
| Placebo | Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. | headache | 9 participants |
| Placebo | Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. | dizziness | 12 participants |
| Pregabalin | Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. | dizziness | 17 participants |
| Pregabalin | Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. | PONV | 3 participants |
| Pregabalin | Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. | headache | 5 participants |
| Pregabalin | Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. | sedation | 13 participants |
Primary
Pain Scores (Verbal Numerical Rating Scale;VNRS) During Postoperative Hours.
Pain was evaluated using an 11-point verbal numerical rating scale (VNRS). Patients were instructed preoperatively to express their pain on the 0-10 VNRS, where 0 represents no pain at all and 10 represents the worst pain imaginable.
Time frame: 1, 6, 24, 48 hour
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Pain Scores (Verbal Numerical Rating Scale;VNRS) During Postoperative Hours. | 1 hr | 7 Units on a scale | Full Range 1.8 |
| Placebo | Pain Scores (Verbal Numerical Rating Scale;VNRS) During Postoperative Hours. | 6 hr | 6 Units on a scale | Full Range 2.1 |
| Placebo | Pain Scores (Verbal Numerical Rating Scale;VNRS) During Postoperative Hours. | 24 hr | 5 Units on a scale | Full Range 1.7 |
| Placebo | Pain Scores (Verbal Numerical Rating Scale;VNRS) During Postoperative Hours. | 48 hr | 3 Units on a scale | Full Range 1.8 |
| Pregabalin | Pain Scores (Verbal Numerical Rating Scale;VNRS) During Postoperative Hours. | 48 hr | 2 Units on a scale | Full Range 1.3 |
| Pregabalin | Pain Scores (Verbal Numerical Rating Scale;VNRS) During Postoperative Hours. | 1 hr | 5 Units on a scale | Full Range 2.1 |
| Pregabalin | Pain Scores (Verbal Numerical Rating Scale;VNRS) During Postoperative Hours. | 24 hr | 3 Units on a scale | Full Range 1.5 |
| Pregabalin | Pain Scores (Verbal Numerical Rating Scale;VNRS) During Postoperative Hours. | 6 hr | 5 Units on a scale | Full Range 2.2 |
Secondary
Pain Scores (VNRS) at 1 Week and 1 Month After Operation
Pain was evaluated using an 11-point verbal numerical rating scale (VNRS). Patients were instructed preoperatively to express their pain on the 0-10 VNRS, where 0 represents no pain at all and 10 represents the worst pain imaginable.
Time frame: 1 week, 1 month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Pain Scores (VNRS) at 1 Week and 1 Month After Operation | 1 month | 1.7 Units on a scale | Standard Deviation 1.6 |
| Placebo | Pain Scores (VNRS) at 1 Week and 1 Month After Operation | 1 week | 2.9 Units on a scale | Standard Deviation 1.3 |
| Pregabalin | Pain Scores (VNRS) at 1 Week and 1 Month After Operation | 1 week | 1.4 Units on a scale | Standard Deviation 0.9 |
| Pregabalin | Pain Scores (VNRS) at 1 Week and 1 Month After Operation | 1 month | 0.6 Units on a scale | Standard Deviation 0.6 |