The Using Postoperative Ketamine and Exploring the Effect on Endometriosis Pain (UPKEEEP) Study

• ClinicalTrials.gov Identifier: NCT05229653
• Recruitment Status: Recruiting
• First Posted: February 8, 2022
• Last Update Posted: April 14, 2022
• Sponsor: NYU Langone Health
• Information provided by (Responsible Party): NYU Langone Health

Tracking Information

• First Submitted Date: January 18, 2022
• First Posted Date: February 8, 2022
• Last Update Posted Date: April 14, 2022
• Actual Study Start Date: April 12, 2022
• Estimated Primary Completion Date: June 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 28, 2022)

• Pelvic Pain Score on Visual Analogue Scale (VAS) [ Time Frame: 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.
• Pelvic Pain Score on Visual Analogue Scale (VAS) [ Time Frame: Post-Operative Day (POD) 1 ]
  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.
• Pelvic Pain Score on Visual Analogue Scale (VAS) [ Time Frame: Post-Operative Day (POD) 27 ]
  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.
• Pelvic Pain Score on Visual Analogue Scale (VAS) [ Time Frame: Post-Operative Day (POD) 55 ]
  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.
• Pelvic Pain Score on Visual Analogue Scale (VAS) [ Time Frame: Post-Operative Day (POD) 83 ]
  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.

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 28, 2022)

• Score on General Anxiety Disorder-7 Screener (GAD-7) [ Time Frame: 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 General Anxiety Disorder-7 Screener (GAD-7) [ Time Frame: Post-Operative Day (POD) 1 ]
  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 General Anxiety Disorder-7 Screener (GAD-7) [ Time Frame: Post-Operative Day (POD) 27 ]
  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 General Anxiety Disorder-7 Screener (GAD-7) [ Time Frame: Post-Operative Day (POD) 55 ]
  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 General Anxiety Disorder-7 Screener (GAD-7) [ Time Frame: Post-Operative Day (POD) 83 ]
  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) [ Time Frame: 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 Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Post-Operative Day (POD) 1 ]
  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 Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Post-Operative Day (POD) 27 ]
  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 Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Post-Operative Day (POD) 55 ]
  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 Montgomery-Åsberg Depression Rating Scale (MADRS) [ Time Frame: Post-Operative Day (POD) 83 ]
  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 [ Time Frame: 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.
• Score on Endometriosis Health Profile-30 (EHP-30) Questionnaire [ Time Frame: Post-Operative Day (POD) 1 ]
  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.
• Score on Endometriosis Health Profile-30 (EHP-30) Questionnaire [ Time Frame: Post-Operative Day (POD) 27 ]
  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.
• Score on Endometriosis Health Profile-30 (EHP-30) Questionnaire [ Time Frame: Post-Operative Day (POD) 55 ]
  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.
• Score on Endometriosis Health Profile-30 (EHP-30) Questionnaire [ Time Frame: Post-Operative Day (POD) 83 ]
  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 [ Time Frame: 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Using Postoperative Ketamine and Exploring the Effect on Endometriosis Pain (UPKEEEP) Study
• Official Title: Phase I Randomized, Single-blind, Placebo-controlled, Single-center Study of the Effect of Postoperative Administration of Single Dose Ketamine on Pain and Recovery After Robotic Removal of Endometriosis in Patients With Chronic Pelvic Pain
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment

Condition

• Endometriosis
• Post Operative Pain

Intervention

• Drug: 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.
• Drug: 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.

Study Arms

• Experimental: Low-Dose Ketamine (LDK) Treatment Group
  Intervention: Drug: Ketamine
• Placebo Comparator: Control Group
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 28, 2022): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2022
• Estimated Primary Completion Date: June 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Kathy Huang, MD; (212) 545-5400; Kathy.Huang@nyulangone.org

Contact: Justin Zaslavsky; (847) 826-5927; Justin.zaslavsky@nyulangone.org

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05229653
• Other Study ID Numbers: 21-01032
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) will be shared upon reasonable request.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to Kathy.haung@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

• Current Responsible Party: NYU Langone Health
• Original Responsible Party: Same as current
• Current Study Sponsor: NYU Langone Health
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Kathy Huang, MD; NYU Langone Health

• PRS Account: NYU Langone Health
• Verification Date: April 2022