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

Endometriosis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05229653
• Other study ID #: 21-01032
• Status: Recruiting
• Phase: Phase 1
• Start date: April 12, 2022
• Est. completion date: January 1, 2025

Study information

• Verified date: December 2023
• Source: NYU Langone Health
• Contact: Kathy Huang, MD
• Phone: (212) 545-5400
• Email: Kathy.Huang[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endometriosis
• Pain, Postoperative
• 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.
• 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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline
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.	Post-Operative Day (POD) 1
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.	Post-Operative Day (POD) 27
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.	Post-Operative Day (POD) 55
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.	Post-Operative Day (POD) 83
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.	Baseline
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.	Post-Operative Day (POD) 1
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.	Post-Operative Day (POD) 27
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.	Post-Operative Day (POD) 55
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.	Post-Operative Day (POD) 83
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.	Baseline
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.	Post-Operative Day (POD) 1
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.	Post-Operative Day (POD) 27
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.	Post-Operative Day (POD) 55
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.	Post-Operative Day (POD) 83
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.	Baseline
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.	Post-Operative Day (POD) 1
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.	Post-Operative Day (POD) 27
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.	Post-Operative Day (POD) 55
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.	Post-Operative Day (POD) 83
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.	Baseline, Post-Operative Day (POD) 83