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Esketamine as Treatment for Chronic Pain Due to Endometriosis: a RCT Study

ConditionsEndometriosisChronic Pelvic Pain Syndrome
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorReinier de Graaf Groep

About this trial

The goal of this randomized controlled trial is to investigate the effect of esketamine versus placebo on the NRS score for chronic pelvic pain. Secondary endpoints are to assess pain scores, side-effects, quality of life, depressive symptoms and pain coping.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women

All pre-menopausal women aged above 18 years

Rectovaginal space (minimal A1) and/or

Sacrouterine ligaments, cardinal ligaments, pelvic sidewall (minimal B1) and/or

Disqualifiers

Pain score <6 out of 10 (NRS) for chronic pelvic pain

Endometriosis affecting the bladder and ureter

Increased intracranial pressure

Poorly regulated hypertension, >180/100mmHg at rest

Trial design

Design model

Parallel

Treatments tested in this trial

  • Esketamine hydrochloride

    Drug

    Esketamine dosing regimen is set at 0.1 mg/kg/h as starting dosage. Dosage will be gradually increased based on heart rate, oxygen saturation, blood pressure and side effects (e.g. nausea and dissociative effects) during a period of 8 hours to a maximum of 0.5 mg/kg/h (in steps of 0.1-0.3-0.5 mg/kg/hour). This dosage regimen is similar to that used earlier by Sigtermans et al. \[1\].

  • Placebo

    Drug

    8 hour infusion with saline (NaCl 0.9%)

Treatment groups

56 Participants
are divided into 2 treatment groups
Group A: EsketamineExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Chronic pelvic pain

The effect of treatment allocation on the NRS score for chronic pelvic pain. The NRS scale ranges from 0 (no pain) to 10 (worst pain imaginable).

Time frame
4 weeks after the 8 hour infusion treatment.

Secondary outcomes

1

Dysmenorrhea

NRS score for dysmenorrhea. The NRS scale ranges from 0 (no pain) to 10 (worst pain imaginable).

Time frame
Baseline and week 4, 8, 12 after the 8 hour infusion treatment
2

Dyschezia

NRS scores for dyschezia.The NRS scale ranges from 0 (no pain) to 10 (worst pain imaginable).

Time frame
Baseline and week 4, 8, 12 after the 8 hour infusion treatment
3

Dysuria

NRS scores for dysuria. The NRS scale ranges from 0 (no pain) to 10 (worst pain imaginable).

Time frame
Baseline and week 4, 8, 12 after the 8 hour infusion treatment
4

Dyspareunia

NRS score for dyspareunia. The NRS scale ranges from 0 (no pain) to 10 (worst pain imaginable).

Time frame
Baseline and week 4, 8, 12 after the 8 hour infusion treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Reinier de Graaf Groep

Lead sponsor

Source ClinicalTrials.gov
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