Endometriosis, Post Operative Pain
Conditions
Brief summary
This is a randomized, single blinded, placebo-controlled trial to study the effectiveness of a subanesthetic dose (0.6 mg/kg) of ketamine versus placebo (saline) on postoperative pain and pain on adult female chronic pelvic pain patients undergoing robotic removal of endometriosis. The objective of the study is to explore the effect of a sub anesthetic dose of ketamine (0.6 mg/kg) vs. saline control on postoperative pain and recovery in chronic pelvic pain patients who have undergone robotic removal of endometriosis.
Interventions
DRUGKetamine
Participants in this arm will receive intravenously (IV) ketamine (0.6 mg/kg) while recovering in the post anesthesia care unit (PACU) on the day of the surgery after subject has been deemed to be stable (hemodynamically stable, awake). The study physician will administer the study intervention via an intravenous pump to deliver 0.6 mg/kg ketamine over at least 30 minutes.
DRUGPlacebo
Participants in this arm will receive intravenously (IV) matching equal dose of placebo while recovering in the post anesthesia care unit (PACU) on the day of the surgery after subject has been deemed to be stable (hemodynamically stable, awake). The study physician will administer the study intervention via an intravenous pump to deliver equal volume saline over at least 30 minutes.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Adults, aged 18 to 65 years old 2. Experiencing chronic pain, defined as experiencing moderate to severe pelvic pain for greater than 6 months 3. Scheduled to undergo robotic endometriosis removal surgery 4. Willing to comply with all study procedures and be available for the duration of the study. 5. Subject is medically stable.
Exclusion criteria
1. Cognitive impairment (by history) or clinical signs of altered mental status such as confusion, amnesia, disorientation, fluctuating levels of alertness, etc. that may interference with adherence to study procedures and/or participant safety. 2. Past ketamine or phencyclidine misuse or abuse 3. Schizophrenia or history of psychosis 4. Known sensitivity or allergy to ketamine 5. Liver or renal insufficiency. 6. History of uncontrolled hypertension, chest pain, cardiac arrythmia, stroke, head trauma, intracranial mass or hemorrhage or pressure, glaucoma, acute globe injury, uncontrolled thyroid disease, porphyria, or any other contraindication to ketamine. Use of lamotrigine, alfentanil, physostigmine, and 4-aminopyridine are contraindicated 7. Pregnancy or nursing women 8. Currently participating in another pain interventional trial 9. Unwillingness to give informed consent 10. Non-English-speaking patients as the EHP-30 instrument has only been licensed to NYULH in English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pelvic Pain Score on Visual Analogue Scale (VAS) | Baseline | VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Score on General Anxiety Disorder-7 Screener (GAD-7) | Baseline | GAD-7 consists of 7 problems. Participants report how often they have been bothered by the 7 problems over the last 2 weeks on a Likert Scale from 0 (not at all) to 3 (nearly every day). The total score range is 0-21; the higher the score, the more severe the anxiety. 0-4=minimal anxiety, 5-9=mild, 10-14=moderate, 15-21=severe anxiety. |
| Score on Montgomery-Åsberg Depression Rating Scale (MADRS) | Baseline | MADRS is a 10-item diagnostic questionnaire that psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item is rated on a 0-6 scale, resulting in a total score range of 0-60. The higher the score, the more severe the depression. |
| Score on Endometriosis Health Profile-30 (EHP-30) Questionnaire | Baseline | A Health-Related Quality of Life (HRQoL) patient self-report tool used to measure the wide range of effects that endometriosis can have on patients' lives, including work, relationship with child/children, sexual relationship, feelings about medical profession, feelings about treatment, and feelings about infertility. The EHP-30 questions are asked regarding endometriosis in the previous 4 weeks and are answered on a 5-point Likert scale, where 0=never, 1=rarely, 2=sometimes, 3=often, and 4=always. Raw scores for the questions within a scale are summed and transformed to a 0-100 scale, with higher scores indicating worse HRQoL. |
| Change in Opioid Use | Baseline, Post-Operative Day (POD) 83 | Opioid use will be assessed through medical records and subject reports. Assessment of opiate use will be used to determine the opiate-sparing effects of the study drug. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Low-Dose Ketamine (LDK) Treatment Group Ketamine: Participants in this arm will receive intravenously (IV) ketamine (0.6 mg/kg) while recovering in the post anesthesia care unit (PACU) on the day of the surgery after subject has been deemed to be stable (hemodynamically stable, awake). The study physician will administer the study intervention via an intravenous pump to deliver 0.6 mg/kg ketamine over at least 30 minutes. | 1 |
| Control Group Placebo: Participants in this arm will receive intravenously (IV) matching equal dose of placebo while recovering in the post anesthesia care unit (PACU) on the day of the surgery after subject has been deemed to be stable (hemodynamically stable, awake). The study physician will administer the study intervention via an intravenous pump to deliver equal volume saline over at least 30 minutes. | 0 |
| Total | 1 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
Baseline characteristics
| Characteristic | Low-Dose Ketamine (LDK) Treatment Group | Total |
|---|---|---|
| Age, Continuous | 45 years STANDARD_DEVIATION 0 | 45 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants |
| Region of Enrollment United States | 1 participants | 1 participants |
| Sex: Female, Male Female | 1 Participants | 1 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 0 |
| other Total, other adverse events | 0 / 1 | 0 / 0 |
| serious Total, serious adverse events | 0 / 1 | 0 / 0 |
Outcome results
Primary
Pelvic Pain Score on Visual Analogue Scale (VAS)
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
Time frame: Baseline
Population: Only 1 participant was enrolled, participant was lost to follow up before any outcome measure data was collected.
Primary
Pelvic Pain Score on Visual Analogue Scale (VAS)
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
Time frame: Post-Operative Day (POD) 1
Population: Only 1 participant was enrolled, participant was lost to follow up before any outcome measure data was collected.
Primary
Pelvic Pain Score on Visual Analogue Scale (VAS)
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
Time frame: Post-Operative Day (POD) 27
Population: Only 1 participant was enrolled, participant was lost to follow up before any outcome measure data was collected.
Primary
Pelvic Pain Score on Visual Analogue Scale (VAS)
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
Time frame: Post-Operative Day (POD) 55
Population: Only 1 participant was enrolled, participant was lost to follow up before any outcome measure data was collected.
Primary
Pelvic Pain Score on Visual Analogue Scale (VAS)
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
Time frame: Post-Operative Day (POD) 83
Population: Only 1 participant was enrolled, participant was lost to follow up before any outcome measure data was collected.
Secondary
Change in Opioid Use
Opioid use will be assessed through medical records and subject reports. Assessment of opiate use will be used to determine the opiate-sparing effects of the study drug.
Time frame: Baseline, Post-Operative Day (POD) 83
Population: Only 1 participant was enrolled, participant was lost to follow up before any outcome measure data was collected.
Secondary
Score on Endometriosis Health Profile-30 (EHP-30) Questionnaire
A Health-Related Quality of Life (HRQoL) patient self-report tool used to measure the wide range of effects that endometriosis can have on patients' lives, including work, relationship with child/children, sexual relationship, feelings about medical profession, feelings about treatment, and feelings about infertility. The EHP-30 questions are asked regarding endometriosis in the previous 4 weeks and are answered on a 5-point Likert scale, where 0=never, 1=rarely, 2=sometimes, 3=often, and 4=always. Raw scores for the questions within a scale are summed and transformed to a 0-100 scale, with higher scores indicating worse HRQoL.
Time frame: Post-Operative Day (POD) 55
Population: Only 1 participant was enrolled, participant was lost to follow up before any outcome measure data was collected.
Secondary
Score on Endometriosis Health Profile-30 (EHP-30) Questionnaire
A Health-Related Quality of Life (HRQoL) patient self-report tool used to measure the wide range of effects that endometriosis can have on patients' lives, including work, relationship with child/children, sexual relationship, feelings about medical profession, feelings about treatment, and feelings about infertility. The EHP-30 questions are asked regarding endometriosis in the previous 4 weeks and are answered on a 5-point Likert scale, where 0=never, 1=rarely, 2=sometimes, 3=often, and 4=always. Raw scores for the questions within a scale are summed and transformed to a 0-100 scale, with higher scores indicating worse HRQoL.
Time frame: Post-Operative Day (POD) 27
Population: Only 1 participant was enrolled, participant was lost to follow up before any outcome measure data was collected.
Secondary
Score on Endometriosis Health Profile-30 (EHP-30) Questionnaire
A Health-Related Quality of Life (HRQoL) patient self-report tool used to measure the wide range of effects that endometriosis can have on patients' lives, including work, relationship with child/children, sexual relationship, feelings about medical profession, feelings about treatment, and feelings about infertility. The EHP-30 questions are asked regarding endometriosis in the previous 4 weeks and are answered on a 5-point Likert scale, where 0=never, 1=rarely, 2=sometimes, 3=often, and 4=always. Raw scores for the questions within a scale are summed and transformed to a 0-100 scale, with higher scores indicating worse HRQoL.
Time frame: Post-Operative Day (POD) 1
Population: Only 1 participant was enrolled, participant was lost to follow up before any outcome measure data was collected.
Secondary
Score on Endometriosis Health Profile-30 (EHP-30) Questionnaire
A Health-Related Quality of Life (HRQoL) patient self-report tool used to measure the wide range of effects that endometriosis can have on patients' lives, including work, relationship with child/children, sexual relationship, feelings about medical profession, feelings about treatment, and feelings about infertility. The EHP-30 questions are asked regarding endometriosis in the previous 4 weeks and are answered on a 5-point Likert scale, where 0=never, 1=rarely, 2=sometimes, 3=often, and 4=always. Raw scores for the questions within a scale are summed and transformed to a 0-100 scale, with higher scores indicating worse HRQoL.
Time frame: Baseline
Population: Only 1 participant was enrolled, participant was lost to follow up before any outcome measure data was collected.
Secondary
Score on Endometriosis Health Profile-30 (EHP-30) Questionnaire
A Health-Related Quality of Life (HRQoL) patient self-report tool used to measure the wide range of effects that endometriosis can have on patients' lives, including work, relationship with child/children, sexual relationship, feelings about medical profession, feelings about treatment, and feelings about infertility. The EHP-30 questions are asked regarding endometriosis in the previous 4 weeks and are answered on a 5-point Likert scale, where 0=never, 1=rarely, 2=sometimes, 3=often, and 4=always. Raw scores for the questions within a scale are summed and transformed to a 0-100 scale, with higher scores indicating worse HRQoL.
Time frame: Post-Operative Day (POD) 83
Population: Only 1 participant was enrolled, participant was lost to follow up before any outcome measure data was collected.
Secondary
Score on General Anxiety Disorder-7 Screener (GAD-7)
GAD-7 consists of 7 problems. Participants report how often they have been bothered by the 7 problems over the last 2 weeks on a Likert Scale from 0 (not at all) to 3 (nearly every day). The total score range is 0-21; the higher the score, the more severe the anxiety. 0-4=minimal anxiety, 5-9=mild, 10-14=moderate, 15-21=severe anxiety.
Time frame: Post-Operative Day (POD) 1
Population: Only 1 participant was enrolled, participant was lost to follow up before any outcome measure data was collected.
Secondary
Score on General Anxiety Disorder-7 Screener (GAD-7)
GAD-7 consists of 7 problems. Participants report how often they have been bothered by the 7 problems over the last 2 weeks on a Likert Scale from 0 (not at all) to 3 (nearly every day). The total score range is 0-21; the higher the score, the more severe the anxiety. 0-4=minimal anxiety, 5-9=mild, 10-14=moderate, 15-21=severe anxiety.
Time frame: Post-Operative Day (POD) 27
Population: Only 1 participant was enrolled, participant was lost to follow up before any outcome measure data was collected.
Secondary
Score on General Anxiety Disorder-7 Screener (GAD-7)
GAD-7 consists of 7 problems. Participants report how often they have been bothered by the 7 problems over the last 2 weeks on a Likert Scale from 0 (not at all) to 3 (nearly every day). The total score range is 0-21; the higher the score, the more severe the anxiety. 0-4=minimal anxiety, 5-9=mild, 10-14=moderate, 15-21=severe anxiety.
Time frame: Post-Operative Day (POD) 55
Population: Only 1 participant was enrolled, participant was lost to follow up before any outcome measure data was collected.
Secondary
Score on General Anxiety Disorder-7 Screener (GAD-7)
GAD-7 consists of 7 problems. Participants report how often they have been bothered by the 7 problems over the last 2 weeks on a Likert Scale from 0 (not at all) to 3 (nearly every day). The total score range is 0-21; the higher the score, the more severe the anxiety. 0-4=minimal anxiety, 5-9=mild, 10-14=moderate, 15-21=severe anxiety.
Time frame: Post-Operative Day (POD) 83
Population: Only 1 participant was enrolled, participant was lost to follow up before any outcome measure data was collected.
Secondary
Score on General Anxiety Disorder-7 Screener (GAD-7)
GAD-7 consists of 7 problems. Participants report how often they have been bothered by the 7 problems over the last 2 weeks on a Likert Scale from 0 (not at all) to 3 (nearly every day). The total score range is 0-21; the higher the score, the more severe the anxiety. 0-4=minimal anxiety, 5-9=mild, 10-14=moderate, 15-21=severe anxiety.
Time frame: Baseline
Population: Only 1 participant was enrolled, participant was lost to follow up before any outcome measure data was collected.
Secondary
Score on Montgomery-Åsberg Depression Rating Scale (MADRS)
MADRS is a 10-item diagnostic questionnaire that psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item is rated on a 0-6 scale, resulting in a total score range of 0-60. The higher the score, the more severe the depression.
Time frame: Post-Operative Day (POD) 55
Population: Only 1 participant was enrolled, participant was lost to follow up before any outcome measure data was collected.
Secondary
Score on Montgomery-Åsberg Depression Rating Scale (MADRS)
MADRS is a 10-item diagnostic questionnaire that psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item is rated on a 0-6 scale, resulting in a total score range of 0-60. The higher the score, the more severe the depression.
Time frame: Post-Operative Day (POD) 27
Population: Only 1 participant was enrolled, participant was lost to follow up before any outcome measure data was collected.
Secondary
Score on Montgomery-Åsberg Depression Rating Scale (MADRS)
MADRS is a 10-item diagnostic questionnaire that psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item is rated on a 0-6 scale, resulting in a total score range of 0-60. The higher the score, the more severe the depression.
Time frame: Post-Operative Day (POD) 1
Population: Only 1 participant was enrolled, participant was lost to follow up before any outcome measure data was collected.
Secondary
Score on Montgomery-Åsberg Depression Rating Scale (MADRS)
MADRS is a 10-item diagnostic questionnaire that psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item is rated on a 0-6 scale, resulting in a total score range of 0-60. The higher the score, the more severe the depression.
Time frame: Baseline
Population: Only 1 participant was enrolled, participant was lost to follow up before any outcome measure data was collected.
Secondary
Score on Montgomery-Åsberg Depression Rating Scale (MADRS)
MADRS is a 10-item diagnostic questionnaire that psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Each item is rated on a 0-6 scale, resulting in a total score range of 0-60. The higher the score, the more severe the depression.
Time frame: Post-Operative Day (POD) 83
Population: Only 1 participant was enrolled, participant was lost to follow up before any outcome measure data was collected.