Clinical trial NCT01329796: Pertubation With Lignocaine in Endometriosis
Official title: Pertubation With Lignocaine in Endometriosis Associated Symptoms Effect Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Endometriosis
Dysmenorrhea
Keywords: dysmenorrhea,
pelvic pain
dyspareunia
endometriosis
Lead sponsor: Isifer AB
Sponsor class: INDUSTRY
Collaborators: name: Region Stockholm
First posted: 2011-04-06
Enrollment: 42
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Age \> 20 years
* endometriosis verified by laparoscopy
* dysmenorrhea or pelvic pain defined as a pain-score of \>50 mm (VAS)
* normal Fallopian tubes
* regular menstrual cycles 21-35 days
* treatment with oral contraceptives (OC) ongoing \> 1 month and continued during the trial
* previous hormonal treatment discontinued \> 1 month (OC, gestagens) and \> 6 months (GnRH)
* no wish for pregnancy during the study
* normal Pap-smear
* negative Chlamydia-test
* negative pregnancy-test
* informed consent given and signed

Exclusion Criteria:

* Continuous treatment with medication that may increase risk for infection - clinical signs of pelvic inflammatory disease
* hyperreactivity to local anesthesia
* fibroids \> 2 cm
* ongoing treatment with GnRH-analog
* ongoing continuous treatment with high dose gestagens
* pregnancy
* peritubal adhesions
* occluded Fallopian tubes
* inability to understand information or comply with the study procedures
* participation in a clinical study within one year before the present study
* any disease or laboratory finding considered of importance by the investigator not to include the patient

Primary outcomes:
measure: Pain-questionnaire (validated for endometriosis) supplemented with VAS-scale.
timeFrame: After three pertubations
Secondary outcomes:
measure: Quality of life-questionnaire (validated), EHP-30
timeFrame: At the 7th menstruation i.e. after approximately 6 months.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Läkargruppen Victoria Söderhallarna 120
city: Stockholm
country: Sweden
facility: Karolinska Institute, Fertility Unit, K59 Karolinska University Hospital at Huddinge
city: Stockholm
country: Sweden
facility: Department of Gynaecology and Obstetrics Danderyd Hospital
Study officials:
affiliation: Danderyd Hospital, SE-182 88 Stockholm, Sweden
name: Karin Wickström, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska University Hospital at Huddinge SE-141 86 Stockholm, Sweden
name: Greta Edelstam, MD
role: STUDY_DIRECTOR
References:
citation: Wickstrom K, Edelstam G. Minimal clinically important difference for pain on the VAS scale and the relation to quality of life in women with endometriosis. Sex Reprod Healthc. 2017 Oct;13:35-40. doi: 10.1016/j.srhc.2017.05.004. Epub 2017 May 25.
citation: Wickstrom K, Spira J, Edelstam G. Serum concentration of lignocaine after pertubation: an observational study. Drugs R D. 2013 Sep;13(3):235-9. doi: 10.1007/s40268-013-0022-8.
citation: Wickstrom K, Bruse C, Sjosten A, Spira J, Edelstam G. Pertubation with lignocaine as a new treatment of dysmenorrhea due to endometriosis: a randomized controlled trial. Hum Reprod. 2012 Mar;27(3):695-701. doi: 10.1093/humrep/der434. Epub 2012 Jan 9.