Effectiveness of Ketamine Administered by Mesotherapy in Complex Regional Pain Syndrome Type 1 (CRPS1)

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

31

Participants

Timeline

Start Date

November 5, 2021

Primary Completion Date

January 12, 2024

Study Completion Date

January 12, 2024

Conditions
Neuropathic PainComplex Regional Pain Syndrome Type 1
Interventions
DRUG

LIDOCAINE 20 mg

"4 injections (on day 1, day 7, day 14, day 28) by mesotherapy of 20 mg Lidocaine (qsp 6 ml NaCl 0.9%).~Each mesotherapy session includes 2 steps performed chronologically. It will be done within 2 or 3 minutes each one:~* 1st sequence: intra-epidermal injections of 3 ml by manual technique in crossed lines with a 13 mm x 0.30 needle,~* 2nd sequence : superficial intradermal injections of 3 ml (between 1 and 2 mm) using a technique assisted by a Pistor Eliance injector at a frequency of 200 punctures per minute."

DRUG

LIDOCAINE 20 mg + KETAMINE 20 mg

"4 injections (on day 1, day 7, day 14, day 28) by mesotherapy of 20 mg Lidocaine + 20 mg Ketamine (qsp 6 ml NaCl 0.9%).~Each mesotherapy session includes 2 steps performed chronologically. It will be done within 2 or 3 minutes each one:~* 1st sequence: intra-epidermal injections of 3 ml by manual technique in crossed lines with a 13 mm x 0.30 needle,~* 2nd sequence : superficial intradermal injections of 3 ml (between 1 and 2 mm) using a technique assisted by a Pistor Eliance injector at a frequency of 200 punctures per minute."

DRUG

LIDOCAINE 20 mg + KETAMINE 40 mg

"4 injections (on day 1, day 7, day 14, day 28) by mesotherapy of 20 mg Lidocaine + 40 mg Ketamine (qsp 6 ml NaCl 0.9%).~Each mesotherapy session includes 2 steps performed chronologically. It will be done within 2 or 3 minutes each one:~* 1st sequence: intra-epidermal injections of 3 ml by manual technique in crossed lines with a 13 mm x 0.30 needle,~* 2nd sequence : superficial intradermal injections of 3 ml (between 1 and 2 mm) using a technique assisted by a Pistor Eliance injector at a frequency of 200 punctures per minute"

Trial Locations (1)

69437

Department of orthopedic surgery and trauma emergencies of the lower limb, Edouard Herriot Hospital, Hospices Civils de Lyon, Lyon

All Listed Sponsors
lead

Hospices Civils de Lyon

OTHER

NCT04650074 - Effectiveness of Ketamine Administered by Mesotherapy in Complex Regional Pain Syndrome Type 1 (CRPS1) | Biotech Hunter | Biotech Hunter