Pain, Postoperative
Conditions
Keywords
thyroidectomy, pain, postoperative, pregabalin
Brief summary
The investigators hypothesize that pregabalin will decrease post-operative pain scores and analgesic use following robot-assisted endoscopic thyroidectomy 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 the incidence of chronic pain and hypoesthesia in the anterior chest at 3 months after operation.
Interventions
DRUGPregabalin
Pregabalin 150 mg orally
Vitamin Complex 150 mg orally
Sponsors
Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. American Society of Anesthesia physical status class I & II 2. Age ≥ 20 and ≤ 65 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 (VNRS) at 1, 6, 24, 48 Hours Postoperatively. | 1, 6, 24 & 48 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 means no pain at all, and 10 represents the worst pain imaginable |
| The Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. | 1, 6, 24 & 48 hours | 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. We asked patients about sedation, headache, dizziness, blurred vision. |
| Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively | 1, 6, 24 & 48 hours | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Hypoesthesia in the Anterior Chest at 3 Months After Operation. | 3 months | we checked Hypoesthesia in the anterior chest at 3 months after operation by phone. |
Countries
South Korea
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Patients receive oral Placebo 1 hour prior to surgery, and 12 hours later | 49 |
| Pregabalin Patients receive oral pregabalin 1 hour prior to surgery, and 12 hours later | 50 |
| Total | 99 |
Baseline characteristics
| Characteristic | Pregabalin | Placebo | Total |
|---|---|---|---|
| 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 | 50 Participants | 49 Participants | 99 Participants |
| Age Continuous | 38.0 years STANDARD_DEVIATION 8.2 | 38.5 years STANDARD_DEVIATION 9.5 | 38.2 years STANDARD_DEVIATION 8.9 |
| Region of Enrollment Korea, Republic of | 50 participants | 49 participants | 99 participants |
| Sex: Female, Male Female | 48 Participants | 46 Participants | 94 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 6 / 47 | 21 / 47 |
| serious Total, serious adverse events | 0 / 47 | 0 / 47 |
Outcome results
Primary
Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively
Time frame: 1, 6, 24 & 48 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively | 0-1 hour | 31 participants |
| Placebo | Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively | 1-6 hour | 17 participants |
| Placebo | Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively | 6 - 24 hour | 15 participants |
| Placebo | Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively | 24 - 48 hour | 7 participants |
| Pregabalin | Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively | 24 - 48 hour | 1 participants |
| Pregabalin | Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively | 0-1 hour | 26 participants |
| Pregabalin | Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively | 6 - 24 hour | 2 participants |
| Pregabalin | Number of Patients Who Required Additional Analgesics During the First 48 Hours Postoperatively | 1-6 hour | 7 participants |
Primary
Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively.
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 means no pain at all, and 10 represents the worst pain imaginable
Time frame: 1, 6, 24 & 48 hours
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Placebo | Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively. | 1 Hour | 6 VNRS |
| Placebo | Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively. | 6 Hour | 3 VNRS |
| Placebo | Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively. | 24 Hour | 2 VNRS |
| Placebo | Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively. | 48 Hour | 2 VNRS |
| Pregabalin | Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively. | 48 Hour | 1 VNRS |
| Pregabalin | Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively. | 1 Hour | 6 VNRS |
| Pregabalin | Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively. | 24 Hour | 1 VNRS |
| Pregabalin | Pain Scores (VNRS) at 1, 6, 24, 48 Hours Postoperatively. | 6 Hour | 2 VNRS |
Primary
The 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. We asked patients about sedation, headache, dizziness, blurred vision.
Time frame: 1, 6, 24 & 48 hours
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | The Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. | headache | 11 participants |
| Placebo | The Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. | sedation | 1 participants |
| Placebo | The Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. | dizziness | 6 participants |
| Placebo | The Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. | blurred vision | 0 participants |
| Placebo | The Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. | PONV | 10 participants |
| Pregabalin | The Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. | blurred vision | 3 participants |
| Pregabalin | The Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. | PONV | 7 participants |
| Pregabalin | The Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. | headache | 8 participants |
| Pregabalin | The Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. | dizziness | 14 participants |
| Pregabalin | The Number of Participants With the Indicated Side Effects - Nausea & Vomiting, Sedation, Headache, Dizziness Etc. | sedation | 6 participants |
Secondary
Number of Patients With Hypoesthesia in the Anterior Chest at 3 Months After Operation.
we checked Hypoesthesia in the anterior chest at 3 months after operation by phone.
Time frame: 3 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Number of Patients With Hypoesthesia in the Anterior Chest at 3 Months After Operation. | 13 participants |
| Pregabalin | Number of Patients With Hypoesthesia in the Anterior Chest at 3 Months After Operation. | 10 participants |