Pertubation With Lignocaine in Endometriosis (PLEASE)
Endometriosis is a disease of unknown aetiology that can cause severe dysmenorrhea. An altered immune system with elevated levels of cytokines in the peritoneal fluid as well as increased density of nerve fibres, might explain the pathophysiology of dysmenorrhea in endometriosis patients. Lignocaine has anti-inflammatory properties and exerts effect on nerve endings and intra peritoneal macrophages. Pertubation with lignocaine might represent an alternative treatment for endometriosis related dysmenorrhea and avoids the side-effects related to hormonal treatments. A double blind randomized clinical trial, was carried out to evaluate pertubation with lignocaine as a therapy for dysmenorrhea.
Drug: Ringers Solution
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Pertubation With Lignocaine in Endometriosis Associated Symptoms Effect Study|
- Pain-questionnaire (validated for endometriosis) supplemented with VAS-scale. [ Time Frame: After three pertubations ] [ Designated as safety issue: No ]The pain-questionnaire will be filled out: first time during the first period after inclusion in the study (1st menstruation prior to study treatments=baseline for evaluation) and thereafter during 2nd, 3rd, 4 th, 7th, 10th and 13th menstrual periods.
- Quality of life-questionnaire (validated), EHP-30 [ Time Frame: At the 7th menstruation i.e. after approximately 6 months. ] [ Designated as safety issue: No ]The Quality of life-questionnaire will be filled out: first time during the first period after inclusion in the study (1st menstruation prior to study treatment=baseline for evaluation) and thereafter during 7th and 13th menstrual period.
|Study Start Date:||March 2007|
|Study Completion Date:||March 2010|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Experimental: Pertubation with Endole® (lignocaine)
Three treatments were to be given preovulatory at cycle day 6-12 in three sequential menstrual cycles.
Intrauterine flushing, pertubation, three treatments given preovulatory at cycle day 6-12 in three sequential menstrual cycles.
Other Name: Lidocaine
Placebo Comparator: Placebo
Pertubation with Ringer solution, given preovulatory at cycle day 6-12 in three sequential menstrual cycles.
Drug: Ringers Solution
Intrauterine flushing, pertubation, given preovulatory at cycle day 6-12 in three sequential menstrual cycles.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01329796
|Department of Gynaecology and Obstetrics Danderyd Hospital|
|Stockholm, Sweden, 182 88|
|Karolinska Institute, Fertility Unit, K59 Karolinska University Hospital at Huddinge|
|Stockholm, Sweden, 141 86|
|Läkargruppen Victoria Söderhallarna 120|
|Stockholm, Sweden, 118 72|
|Principal Investigator:||Karin Wickström, MD||Danderyd Hospital, SE-182 88 Stockholm, Sweden|
|Study Director:||Greta Edelstam, MD||Karolinska University Hospital at Huddinge SE-141 86 Stockholm, Sweden|