Hemorrhoids, Pain
Conditions
Keywords
hemorrhoids, hemorrhoidectomy, S (+) ketamine, pain
Brief summary
The purpose of this study is to determine whether the use of perioperative intravenous S (+) ketamine reduces the amount and degree of postoperative pain. Furthermore the purpose of this study is to determine whether the use of perioperative intravenous S (+) ketamine effects cognitive function in the early postoperative period.
Detailed description
The mechanism of development of postoperative pain is complex. Central and peripheral sensitization are playing an important role and this can lead to postoperative hypersensitization. Several studies have shown, that S (+) ketamine can be effective to reduce sensitization and postoperative pain. Ketamine (2-O-chlorophenyl-2-methylamino cyclohexanone) is a N-Methyl-D-Aspartat (NMDA) receptor antagonist. S (+) ketamine has a four times stronger affinity to the NMDA receptor compared to R (-) ketamine. The duration of action for S (+) ketamine is shorter than R (-) ketamine and it has fewer side-effects. The purpose of this study is to compare the analgetic effect of pregabalin and placebo used in the perioperative period. The hypothesis is that perioperative intravenous S (+) ketamine gives significant better analgesia than placebo without effecting cognitive function. The study is including patients undergoing hemorrhoidectomy.
Interventions
DRUGS (+) Ketamine
0,35 mg/kg bolus after induction of anaesthesia; 5 ug/kg/min. continuous until the end of surgery
DRUGPlacebo
isotonic saline
Sponsors
Asker & Baerum Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of disc prolapse * Age 18+ * ASA (American Society in Anesthesiology) I-II * written consent
Exclusion criteria
* Age \< 18 * ASA \> II * liver failure * renal failure * heart failure * glaucoma * pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NRS Pain = Numeric Rating Scale (0-10) | 24 hours | The numeric rating scale (NRS) is used to measure the intensity of pain. The value 0 means no pain and the value 10 represents maximal pain. a higher intensity of pain is associated with a worse outcome. |
Countries
Norway
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| S (+) Ketamine | 43 |
| Placebo | 40 |
| Total | 83 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 4 | 2 |
Baseline characteristics
| Characteristic | Placebo | S (+) Ketamine | 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 | 40 Participants | 43 Participants | 83 Participants |
| Age Continuous | 50.2 years STANDARD_DEVIATION 11.4 | 46.4 years STANDARD_DEVIATION 11.6 | 48 years STANDARD_DEVIATION 11.5 |
| Region of Enrollment Norway | 40 participants | 43 participants | 83 participants |
| Sex: Female, Male Female | 22 Participants | 26 Participants | 48 Participants |
| Sex: Female, Male Male | 18 Participants | 17 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 43 | 0 / 40 |
| serious Total, serious adverse events | 0 / 43 | 0 / 40 |
Outcome results
Primary
NRS Pain = Numeric Rating Scale (0-10)
The numeric rating scale (NRS) is used to measure the intensity of pain. The value 0 means no pain and the value 10 represents maximal pain. a higher intensity of pain is associated with a worse outcome.
Time frame: 24 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| S (+) Ketamine | NRS Pain = Numeric Rating Scale (0-10) | 1.6 Units on a scale | Standard Deviation 2.1 |
| Placebo | NRS Pain = Numeric Rating Scale (0-10) | 1.5 Units on a scale | Standard Deviation 1.7 |
p-value: >0.05t-test, 2 sided