Endometriosis and Pain Treatment by Intraoperative Administration of Low-dose Ketamine

NCT06951802 | Recruiting Phase 4

• 1 other identifier: 2024-01677
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

RCT comparing intraoperative administration of low-dose ketamine during laparoscopic endometriosis operation and the postoperative pain outcome

Conditions

Endometriosis

Outcome Measures

Primary Outcomes (1)

• Total opioids prescribed and consumed during hospitalization for endometriosis.

  The primary study outcome is the total opioids consumed during hospitalisation (converted in oral morphine equivalents)

  During hospitalisation, expected to be on average 2-5 days

Secondary Outcomes (6)

• Daily pain severity during hospitalization

  During hospitalisation, expected to be on average 2-5 days

• Postoperative complications

  During hospitalisation, expected to be on average 2-5 days

• Patient wellbeing

  30 days to 6 months after surgery

• Preoperative iron status

  Preoperatively (expected to be on average 2-5 days prior to surgery)

• Pain score

  During hospitalisation, expected to be on average 2-5 days

Study Arms (2)

Group Ketamine

EXPERIMENTAL

Standard anaesthesia with propofol and administration of ketamine.

Drug: Ketamine; Drug: Propofol

Group Control

OTHER

Standard anaesthesia with propofol.

Drug: Propofol

Interventions

Ketamine DRUG

Low-dose administration of ketamine during laparoscopic surgery

Group Ketamine

Propofol DRUG

Control group

Group Control; Group Ketamine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing surgery for endometriosis operation requiring general anaesthesia at the Inselspital, Bern University Hospital, University of Bern, Department of gynaecology and obstetrics.
• Age ≥ 18 years
• American Society of Anesthesiologist (ASA) physical status 1-3
• Patients with known or suspected endometriosis
• Written informed consent.

You may not qualify if:

• Age \< 18 years
• ASA physical status ≥4
• Higher-grade atrioventricular block without pacemaker
• Severe hypovolemia or bradycardia
• Uncontrolled hyper- or hypotension
• Liver disease
• Known malignant hyperthermia
• Cardiovascular instability or severe heart failure (New York Heart Association classification (NYHA) \> III)
• Myocardial infarction during the last 30 days prior to surgery
• Increased intracranial or increased intraocular pressure
• Limited peripheral autonomic activity, hypersensitivity to ketamine or propofol or its components
• Pregnancy
• Rejection or lack of consent of the patient or relatives

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital Bern

Bern, 3010, Switzerland

RECRUITING

Related Publications (17)

• Kanellos P, Nirgianakis K, Siegenthaler F, Vetter C, Mueller MD, Imboden S. Postoperative Pain Is Driven by Preoperative Pain, Not by Endometriosis. J Clin Med. 2021 Oct 15;10(20):4727. doi: 10.3390/jcm10204727.

  PMID: 34682850 BACKGROUND

• Abbott J, Hawe J, Hunter D, Holmes M, Finn P, Garry R. Laparoscopic excision of endometriosis: a randomized, placebo-controlled trial. Fertil Steril. 2004 Oct;82(4):878-84. doi: 10.1016/j.fertnstert.2004.03.046.

  PMID: 15482763 BACKGROUND

• Chiuve SE, Kilpatrick RD, Hornstein MD, Petruski-Ivleva N, Wegrzyn LR, Dabrowski EC, Velentgas P, Snabes MC, Bateman BT. Chronic opioid use and complication risks in women with endometriosis: A cohort study in US administrative claims. Pharmacoepidemiol Drug Saf. 2021 Jun;30(6):787-796. doi: 10.1002/pds.5209. Epub 2021 Mar 16.

  PMID: 33611812 BACKGROUND

• Gerbershagen HJ, Aduckathil S, van Wijck AJ, Peelen LM, Kalkman CJ, Meissner W. Pain intensity on the first day after surgery: a prospective cohort study comparing 179 surgical procedures. Anesthesiology. 2013 Apr;118(4):934-44. doi: 10.1097/ALN.0b013e31828866b3.

  PMID: 23392233 BACKGROUND

• Lirk P, Thiry J, Bonnet MP, Joshi GP, Bonnet F; PROSPECT Working Group. Pain management after laparoscopic hysterectomy: systematic review of literature and PROSPECT recommendations. Reg Anesth Pain Med. 2019 Apr;44(4):425-436. doi: 10.1136/rapm-2018-100024. Epub 2019 Feb 3.

  PMID: 30914471 BACKGROUND

• Lopez A, Cacoub P, Macdougall IC, Peyrin-Biroulet L. Iron deficiency anaemia. Lancet. 2016 Feb 27;387(10021):907-16. doi: 10.1016/S0140-6736(15)60865-0. Epub 2015 Aug 24.

  PMID: 26314490 BACKGROUND

• Cappellini MD, Comin-Colet J, de Francisco A, Dignass A, Doehner W, Lam CS, Macdougall IC, Rogler G, Camaschella C, Kadir R, Kassebaum NJ, Spahn DR, Taher AT, Musallam KM; IRON CORE Group. Iron deficiency across chronic inflammatory conditions: International expert opinion on definition, diagnosis, and management. Am J Hematol. 2017 Oct;92(10):1068-1078. doi: 10.1002/ajh.24820. Epub 2017 Jul 7.

  PMID: 28612425 BACKGROUND

• World Health Organization. (2021). Anaemia in women and children. The Global Health Observatory. Retrieved July 4, 2022, from. https://www.who.int/data/gho/data/themes/topics/anaemia_ in_women_and_children

  BACKGROUND

• Gete DG, Doust J, Mortlock S, Montgomery G, Mishra GD. Risk of Iron Deficiency in Women With Endometriosis: A Population-Based Prospective Cohort Study. Womens Health Issues. 2024 May-Jun;34(3):317-324. doi: 10.1016/j.whi.2024.03.004. Epub 2024 Apr 24.

  PMID: 38658289 BACKGROUND

• Maddern J, Grundy L, Castro J, Brierley SM. Pain in Endometriosis. Front Cell Neurosci. 2020 Oct 6;14:590823. doi: 10.3389/fncel.2020.590823. eCollection 2020.

  PMID: 33132854 BACKGROUND

• Wyatt J, Fernando SM, Powell SG, Hill CJ, Arshad I, Probert C, Ahmed S, Hapangama DK. The role of iron in the pathogenesis of endometriosis: a systematic review. Hum Reprod Open. 2023 Jul 27;2023(3):hoad033. doi: 10.1093/hropen/hoad033. eCollection 2023.

  PMID: 37638130 BACKGROUND

• Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.

  PMID: 28403427 BACKGROUND

• Glare P, Aubrey KR, Myles PS. Transition from acute to chronic pain after surgery. Lancet. 2019 Apr 13;393(10180):1537-1546. doi: 10.1016/S0140-6736(19)30352-6.

  PMID: 30983589 BACKGROUND

• Schwenk ES, Viscusi ER, Buvanendran A, Hurley RW, Wasan AD, Narouze S, Bhatia A, Davis FN, Hooten WM, Cohen SP. Consensus Guidelines on the Use of Intravenous Ketamine Infusions for Acute Pain Management From the American Society of Regional Anesthesia and Pain Medicine, the American Academy of Pain Medicine, and the American Society of Anesthesiologists. Reg Anesth Pain Med. 2018 Jul;43(5):456-466. doi: 10.1097/AAP.0000000000000806.

  PMID: 29870457 BACKGROUND

• Wolfe F, Clauw DJ, Fitzcharles MA, Goldenberg DL, Hauser W, Katz RS, Mease P, Russell AS, Russell IJ, Winfield JB. Fibromyalgia criteria and severity scales for clinical and epidemiological studies: a modification of the ACR Preliminary Diagnostic Criteria for Fibromyalgia. J Rheumatol. 2011 Jun;38(6):1113-22. doi: 10.3899/jrheum.100594. Epub 2011 Feb 1.

  PMID: 21285161 BACKGROUND

• Shirvalkar P, Prosky J, Chin G, Ahmadipour P, Sani OG, Desai M, Schmitgen A, Dawes H, Shanechi MM, Starr PA, Chang EF. First-in-human prediction of chronic pain state using intracranial neural biomarkers. Nat Neurosci. 2023 Jun;26(6):1090-1099. doi: 10.1038/s41593-023-01338-z. Epub 2023 May 22.

  PMID: 37217725 BACKGROUND

• Vetter C. Opioid-sparing by low-dose ketamine for endometriosis surgery. A single-center, prospective, randomized, trial. Pain Manag. 2026 Jan 18:1-6. doi: 10.1080/17581869.2026.2613800. Online ahead of print.

  PMID: 41550074 DERIVED

MeSH Terms

Conditions

Endometriosis

Interventions

Ketamine; Propofol

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic

Study Officials

• Christian Vetter, MD

  Dep. of Anaesthesiology and Pain Medicine, Inselsptial Bern

  STUDY CHAIR

Central Study Contacts

Christian Vetter, MD

CONTACT

+416343776; christian.vetter@insel.ch

Gianluca Comazzi, MD

CONTACT

+416322111; gianluca.comazzi@insel.ch

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: See description Model
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomised controlled prospective trial in two groups. Group 1 will receive standard anaesthesia with propofol and ketamine. Group 2 will receive standard anaesthesia with propofol alone.

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: April 30, 2025
• Study Start: December 3, 2024
• Primary Completion: June 30, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 30, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)