Esketamine hydrochloride for Complex regional pain syndrome

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years"}
• {"criterion_text":"- Meeting the new International Association for the Study of Pain (IASP) diagnostic criteria for CRPS (“the Budapest Criteria) or having met the new IASP diagnostic criteria of CRPS (“CRPS with Remission of Some features”)"}
• {"criterion_text":"- Willing and capable to participate in the study."}
• {"criterion_text":"- CRPS in one upper extremity and/or CRPS in one lower extremity"}
• {"criterion_text":"- Treatment in an elective setting"}
• {"criterion_text":"- Adequate comprehension of the Dutch language"}

Exclusion criteria

• {"criterion_text":"- Contraindications to and precautions for use of subanesthetic doses of ketamine for chronic pain are listed by Cohen et al. and the Dutch CRPS guidelines and our clinical protocol"}

Primary endpoints

• {"endpoint_text":"- Pain intensity measured by Numerical Rating Scale (NRS). The current NRS score reflecting the pain intensity at the moment when asked and the average NRS score of the last 24 hours. (T0, T3, T4)","definition_or_measurement_approach":"Measured using the Numerical Rating Scale (NRS): current NRS score at time of question and average NRS score over the last 24 hours at timepoints T0, T3 and T4."}

Secondary endpoints

• {"endpoint_text":"- To assess protocol deviations due to logistical problems for each of the administration regimens: premature termination (due to i.e. bed capacity problems), waiting time for therapy (weeks) and compliance of the patients. (T1, T2)","definition_or_measurement_approach":"Assessment of protocol deviations including premature termination reasons (e.g., bed capacity), waiting time for therapy in weeks, and patient compliance at T1 and T2."}
• {"endpoint_text":"- Number and severity of intervention related adverse events: Psychomimetic (dysphoria, euphoria, hallucinations, nightmares and vivid dreams, anxiety, agitation), blurry vision or diplopia, nausea and / or vomiting, sedation, hepatic toxicity, headache and dislocation of peripheral intravenous catheter (T1, T2)","definition_or_measurement_approach":"Count and grade intervention-related adverse events (specified symptom categories) recorded at T1 and T2; severity grading as per study safety reporting procedures."}
• {"endpoint_text":"- Number of administered co-interventions related to adverse events (benzodiazepines, clonidine, granisetron). (T1)","definition_or_measurement_approach":"Record number of administered co-interventions for adverse events (e.g., benzodiazepines, clonidine, granisetron) at T1."}
• {"endpoint_text":"- NRS pain scores over time till follow-up T3. The current NRS score reflecting the pain intensity at the moment when asked by telephone and the average NRS score of the last 24 hours. (T1, T2)","definition_or_measurement_approach":"Telephone-assessed current NRS and average 24-hour NRS at T1 and T2; longitudinal tracking until follow-up T3."}
• {"endpoint_text":"- Objectively measured effects of each of the administration regimens on the inflammation; serum levels of sIL-2R and sCD163 will be detected with Enzyme Linked Immunosorbent Assay (ELISA) as measures for T-lymphocyte and macrophage activation, respectively. In addition, T cell populations and monocyte populations will be identified using flow cytometry. (T0, T3)","definition_or_measurement_approach":"Inflammation biomarkers: sIL-2R and sCD163 measured by ELISA; T cell and monocyte populations assessed by flow cytometry at T0 and T3."}
• {"endpoint_text":"- To assess the sensory-discriminative dimensions of pain before and after ketamine treatment; Quantitative Sensory Testing (T0, T3)","definition_or_measurement_approach":"Quantitative Sensory Testing performed at T0 and T3 to evaluate sensory-discriminative pain dimensions."}
• {"endpoint_text":"- Objectively measured effects of each of the administration regimens on symptoms vasomotor disturbances; Thermography (T0, T3)","definition_or_measurement_approach":"Thermography assessments at T0 and T3 to measure vasomotor disturbances."}
• {"endpoint_text":"- Dose reduction of pain medication at follow after three months and six months (T3, T4)","definition_or_measurement_approach":"Record changes in pain medication dosing at 3 months (T3) and 6 months (T4) post-treatment initiation."}
• {"endpoint_text":"- CRPS symptoms and signs based on the Budapest diagnostic clinical criteria; CRPS severity score (20). (T0, T3)","definition_or_measurement_approach":"Assessment of CRPS signs/symptoms per Budapest criteria and CRPS severity score (20) at T0 and T3."}
• {"endpoint_text":"- Questionnaires COMPACT (Core Outcome Measurement set for complex regional PAin syndrome Clinical sTudies) (42, 43):","definition_or_measurement_approach":"Administration of COMPACT questionnaires (core outcome measurement set for CRPS clinical studies) as specified in study schedule."}

Netherlands

Earliest CTIS Part Ii Submission Date

17-04-2024

Latest Decision Or Authorization Date

22-04-2024

Processing Time Days

5

Number Of Sites

1

Number Of Participants

60

Primary sponsor

Full Name

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands