EndometriosisPhase 4NCT06951802
Endometriosis and Pain Treatment by Intraoperative Administration of Low-dose Ketamine
A Phase 4 study testing Ketamine and Propofol in people with Endometriosis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
RCT comparing intraoperative administration of low-dose ketamine during laparoscopic endometriosis operation and the postoperative pain outcome Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometriosis
- What is being tested?
- Ketamine and Propofol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteSwitzerland
- Study dates
- 3 Dec 2024to 31 Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Age < 18 years
- ASA physical status ≥4
- Higher-grade atrioventricular block without pacemaker
- Severe hypovolemia or bradycardia
- Uncontrolled hyper- or hypotension
- Liver disease
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Inselspital Bern
Bern, 3010
Christian cv Vetter, MD, +41 632 52 83, christian.vetter@freenet.de
About this study
Official title: Endometriosis and Pain Treatment by Intraoperative Administration of Low-dose Ketamine A Single-Centre, Prospective, Randomized, Controlled Trial
RCT comparing intraoperative administration of low-dose ketamine during laparoscopic endometriosis operation and the postoperative pain outcome
Read the detailed description
Endometriosis affects 10% of women of childbearing age and 25% - 50% of infertile women worldwide. Although most patients with endometriosis are completely asymptomatic, there are still a significant proportion of patients whose quality of life is impaired by the disease, resulting in chronic pelvic pain.
Hysterectomy is the most common surgical procedure performed in nonpregnant women when conservative strategies are ineffective. However, there is a poor correlation between objective findings of significant endometriosis and pain severity. Women with endometriosis are at a four-fold greater risk of long-term opioid use than those without endometriosis. Approximately 30% of women who undergo surgery for endometriosis report persistent pain after the surgical removal of the lesion(s). In addition to surgical trauma, other predisposing factors can influence the recovery or progression of chronic diseases, which should be considered when selecting perioperative treatment. Furthermore, studies have shown that in many surgical procedures, incision size and degree of tissue trauma are poorly related to postoperative pain intensity, depending on the pain treatment. After surgery, postoperative pain may be severe overall but usually resolves within the first day of surgery with a Numeric Rating Scale (NRS) pain score ≤ 4. Pain from laparoscopic endometriosis operation includes incisional pain, which may also be severe initially but subsides within the first half of the day; visceral pain that takes longer to resolve (up to a day); and shoulder pain (e.g., shoulder tip pain) that is milder. However, approximately 80% of women develop this condition after gynecologic laparoscopy procedures, which usually disappears within 24 hours and may last for several days. The typical duration of opioid rescue medication use is approximately four days. They should not cause discomfort or limit postoperative recovery.
Although the cause of endometriosis is not yet fully understood, chronic inflammation(s) and increased menstrual bleeding often leads to iron deficiency and even anemia. Iron deficiency anemia is the most common form of anemia, accounting for 50%. In 2019, the prevalence of girls and women of childbearing age (15 - 49 years) with anemia worldwide averaged 30%. For Switzerland, iron deficiency anemia is reported at 11.2 % and is well below the global average. Since iron and its deficiency play an important role in the pathogenesis of endometriosis and possibly also maintain it, it does not surprise that endometriosis patients have an increased risk of iron deficiency or anemia.These patients with a latent or manifest iron deficiency also complain of pain. Up to now, there are only indications that iron could play a role in the proinflammatory pain transmission pathways in endometriosis and could probably maintain and trigger chronic pain. As with nonsurgical chronic pain, psychological and social factors have an important impact that may persist for months or years after surgery. Suboptimal treatment of acute pain has many negative consequences including increased morbidity, impaired physical function and quality of life, slower recovery, prolonged opioid use during and after hospitalization, and increased care costs. Furthermore, in a significant proportion of patients, early postoperative pain appears to trigger pain that may persist for several months. Specifically, younger age, non-white race, lower education, history of sleep disorders, current smoking and alcohol use, high preoperative fibromyalgia screening scores, and high anxiety levels were associated with higher pain severity and excessive pain and may be underlying determinants. Also previous opioid consumption contributes to persistent postoperative pain. As pain is both a sensory and an emotional experience, psychological factors such as mood, disability, and pain coping (e.g., pain self-efficacy and pain catastrophizing) play an important role in this setting. Therefore, patients, particularly those with a predisposition or known tendency for depression, anxiety, or catastrophic symptoms, are at a high risk of developing chronic postsurgical pain. However, in some patients, acute postoperative pain persists beyond the tissue-healing period and develops into a chronic pain state. Approximately 10% of the patients undergoing surgery and 30% of those with endometriosis experience chronic pain. Patients, who have already taken preoperative painkillers or have significantly excessive postoperative analgesic consumption are at a risk of developing chronic pain. Nevertheless, opioids are often overused, particularly during the post discharge period. Even today, acute pain management in the setting of trauma, exacerbation of chronic painful conditions, and postsurgical pain, particularly in patients who are opioid-tolerant remains a challenge in the perioperative setting. In this context, ketamine can be used, generally at subanesthetic doses. However, some patients reported severe debilitating side effects of ketamine administration that did not tolerate higher ketamine doses, an adequate balance of analgesia, and adverse effects in continuous low-dose ketamine in the range of 0.1 - 0.5 mg·kg-1·h-1 was described as sufficient.
- Conditions
- Endometriosis
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Low-dose administration of ketamine during laparoscopic surgery
PropofolDrug
Control group
| Study group | Role | What they receive |
|---|---|---|
| Group Ketamine | Experimental | Standard anaesthesia with propofol and administration of ketamine. Receives: Drug: Ketamine; Drug: Propofol |
| Group Control | Other | Standard anaesthesia with propofol. Receives: Drug: Propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: During hospitalisation, expected to be on average 2-5 days
Secondary outcomes (6)
Daily pain severity during hospitalization
Pain score, measured by questionaire, scale from 0 to 10, with higher values corresponding to higher pain level
Measured: During hospitalisation, expected to be on average 2-5 days
Postoperative complications
Number of patients with nausea, vomiting or dizziness
Measured: During hospitalisation, expected to be on average 2-5 days
Patient wellbeing
Measured by questionnaire
Measured: 30 days to 6 months after surgery
Preoperative iron status
Iron status will be classified as normal, latent iron deficiency, or manifest iron deficiency based on laboratory values (e.g., hemoglobin, ferritin, transferrin saturation). Evaluation of manifest or latent iron deficiency, measured by laboratory testing. The scale typically ranges from 0 to over 300 µg/L in clinical practice, but the diagnostic focus is on lower values. For adults, a ferritin concentration below 10-15 µg/L is generally considered indicative of iron deficiency. Higher values indicate better iron stores, but values above the upper reference limit may suggest iron overload or inflammation.
Measured: Preoperatively (expected to be on average 2-5 days prior to surgery)
Pain score
Assessed using the Numeric Rating Scale (NRS), which ranges from 0 (no pain) to 10 (worst imaginable pain). Higher scores indicate worse pain. NRS score (0-10)
Measured: During hospitalisation, expected to be on average 2-5 days
Total postoperative analgesic consumption before discharge
The total amount of analgesics consumed postoperatively, converted to intravenous morphine equivalents using standard conversion tables. Higher values indicate greater analgesic requirement. Milligrams of intravenous morphine equivalent (mg IV MEQ)
Measured: During hospitalisation, expected to be on average 2-5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2025
- Study start3 Dec 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Vetter, MD, Study chair, Dep. of Anaesthesiology and Pain Medicine, Inselsptial Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06951802
- Sponsor's protocol ID
- 2024-01677
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2025
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34682850Abbott 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.
PubMed 15482763Chiuve 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.
PubMed 33611812Gerbershagen 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.
PubMed 23392233Lirk 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.
PubMed 30914471Lopez 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.
PubMed 26314490Cappellini 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.
PubMed 28612425World 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
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.
PubMed 38658289Maddern 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.
PubMed 33132854Wyatt 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.
PubMed 37638130Brummett 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.
PubMed 28403427Glare 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.
PubMed 30983589Schwenk 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.
PubMed 29870457Wolfe 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.
PubMed 21285161
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endometriosis and Pain Treatment by Intraoperative Administration of Low-dose Ketamine A Single-Centre, Prospective, Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT06951802
- Acronym / sponsor ID
- 2024-01677
- Conditions
- Endometriosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 3 Dec 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 30 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RCT comparing intraoperative administration of low-dose ketamine during laparoscopic endometriosis operation and the postoperative pain outcome
Detailed description
Endometriosis affects 10% of women of childbearing age and 25% - 50% of infertile women worldwide. Although most patients with endometriosis are completely asymptomatic, there are still a significant proportion of patients whose quality of life is impaired by the disease, resulting in chronic pelvic pain.
Hysterectomy is the most common surgical procedure performed in nonpregnant women when conservative strategies are ineffective. However, there is a poor correlation between objective findings of significant endometriosis and pain severity. Women with endometriosis are at a four-fold greater risk of long-term opioid use than those without endometriosis. Approximately 30% of women who undergo surgery for endometriosis report persistent pain after the surgical removal of the lesion(s). In addition to surgical trauma, other predisposing factors can influence the recovery or progression of chronic diseases, which should be considered when selecting perioperative treatment. Furthermore, studies have shown that in many surgical procedures, incision size and degree of tissue trauma are poorly related to postoperative pain intensity, depending on the pain treatment. After surgery, postoperative pain may be severe overall but usually resolves within the first day of surgery with a Numeric Rating Scale (NRS) pain score ≤ 4. Pain from laparoscopic endometriosis operation includes incisional pain, which may also be severe initially but subsides within the first half of the day; visceral pain that takes longer to resolve (up to a day); and shoulder pain (e.g., shoulder tip pain) that is milder. However, approximately 80% of women develop this condition after gynecologic laparoscopy procedures, which usually disappears within 24 hours and may last for several days. The typical duration of opioid rescue medication use is approximately four days. They should not cause discomfort or limit postoperative recovery.
Although the cause of endometriosis is not yet fully understood, chronic inflammation(s) and increased menstrual bleeding often leads to iron deficiency and even anemia. Iron deficiency anemia is the most common form of anemia, accounting for 50%. In 2019, the prevalence of girls and women of childbearing age (15 - 49 years) with anemia worldwide averaged 30%. For Switzerland, iron deficiency anemia is reported at 11.2 % and is well below the global average. Since iron and its deficiency play an important role in the pathogenesis of endometriosis and possibly also maintain it, it does not surprise that endometriosis patients have an increased risk of iron deficiency or anemia.These patients with a latent or manifest iron deficiency also complain of pain. Up to now, there are only indications that iron could play a role in the proinflammatory pain transmission pathways in endometriosis and could probably maintain and trigger chronic pain. As with nonsurgical chronic pain, psychological and social factors have an important impact that may persist for months or years after surgery. Suboptimal treatment of acute pain has many negative consequences including increased morbidity, impaired physical function and quality of life, slower recovery, prolonged opioid use during and after hospitalization, and increased care costs. Furthermore, in a significant proportion of patients, early postoperative pain appears to trigger pain that may persist for several months. Specifically, younger age, non-white race, lower education, history of sleep disorders, current smoking and alcohol use, high preoperative fibromyalgia screening scores, and high anxiety levels were associated with higher pain severity and excessive pain and may be underlying determinants. Also previous opioid consumption contributes to persistent postoperative pain. As pain is both a sensory and an emotional experience, psychological factors such as mood, disability, and pain coping (e.g., pain self-efficacy and pain catastrophizing) play an important role in this setting. Therefore, patients, particularly those with a predisposition or known tendency for depression, anxiety, or catastrophic symptoms, are at a high risk of developing chronic postsurgical pain. However, in some patients, acute postoperative pain persists beyond the tissue-healing period and develops into a chronic pain state. Approximately 10% of the patients undergoing surgery and 30% of those with endometriosis experience chronic pain. Patients, who have already taken preoperative painkillers or have significantly excessive postoperative analgesic consumption are at a risk of developing chronic pain. Nevertheless, opioids are often overused, particularly during the post discharge period. Even today, acute pain management in the setting of trauma, exacerbation of chronic painful conditions, and postsurgical pain, particularly in patients who are opioid-tolerant remains a challenge in the perioperative setting. In this context, ketamine can be used, generally at subanesthetic doses. However, some patients reported severe debilitating side effects of ketamine administration that did not tolerate higher ketamine doses, an adequate balance of analgesia, and adverse effects in continuous low-dose ketamine in the range of 0.1 - 0.5 mg·kg-1·h-1 was described as sufficient.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group Ketamine | Experimental | Drug: Ketamine, Drug: PropofolStandard anaesthesia with propofol and administration of ketamine. |
| Group Control | Other | Drug: PropofolStandard anaesthesia with propofol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- Age < 18 years
- ASA physical status ≥4
- Higher-grade atrioventricular block without pacemaker
- Severe hypovolemia or bradycardia
- Uncontrolled hyper- or hypotension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KetamineLow-dose administration of ketamine during laparoscopic surgery | Drug | Group Ketamine |
| PropofolControl group | Drug | Group Control, Group Ketamine |
Primary outcome
Total opioids prescribed and consumed during hospitalization for endometriosis.
Time frame: During hospitalisation, expected to be on average 2-5 days
The primary study outcome is the total opioids consumed during hospitalisation (converted in oral morphine equivalents)
6 secondary outcomes
Daily pain severity during hospitalization
Time frame: During hospitalisation, expected to be on average 2-5 days
Postoperative complications
Time frame: During hospitalisation, expected to be on average 2-5 days
Patient wellbeing
Time frame: 30 days to 6 months after surgery
Preoperative iron status
Time frame: Preoperatively (expected to be on average 2-5 days prior to surgery)
Pain score
Time frame: During hospitalisation, expected to be on average 2-5 days
Total postoperative analgesic consumption before discharge
Time frame: During hospitalisation, expected to be on average 2-5 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Background: PubMed 34682850Kanellos 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.
- Background: PubMed 15482763Abbott 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.
- Background: PubMed 33611812Chiuve 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.
- Background: PubMed 23392233Gerbershagen 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.
- Background: PubMed 30914471Lirk 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.
- Background: PubMed 26314490Lopez 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.
- Background: PubMed 28612425Cappellini 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.
- BackgroundWorld 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: PubMed 38658289Gete 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.
- Background: PubMed 33132854Maddern 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.
- Background: PubMed 37638130Wyatt 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.
- Background: PubMed 28403427Brummett 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christian Vetter, MD study chair
Dep. of Anaesthesiology and Pain Medicine, Inselsptial Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine and Propofol in people with Endometriosis, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian Vetter, MD (+416343776, christian.vetter@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total opioids prescribed and consumed during hospitalization for endometriosis. (time frame: During hospitalisation, expected to be on average 2-5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06951802, which also lists 17 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2025.