NCT05229653

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

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

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endometriosis
• Post Operative Pain

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-04-12
• Primary completion: 2022-10-21
• Completion: 2022-10-21
• First posted: 2022-02-08
• Last updated: 2025-03-28
• Results posted: 2025-03-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study