Pertubation With Lignocaine in Endometriosis

Isifer AB42 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Endometriosis Dysmenorrhea

Interventions

Eligibility

Sex: FEMALEMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (3)

Läkargruppen Victoria Söderhallarna 120

Stockholm, Stockholm County, Sweden

Karolinska Institute, Fertility Unit, K59 Karolinska University Hospital at Huddinge

Stockholm, Stockholm County, Sweden

Department of Gynaecology and Obstetrics Danderyd Hospital

Stockholm, Stockholm County, Sweden

Outcomes

Primary Outcomes

Pain-questionnaire (validated for endometriosis) supplemented with VAS-scale.

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.

Time frame: After three pertubations

Secondary Outcomes

Quality of life-questionnaire (validated), EHP-30

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.

Time frame: At the 7th menstruation i.e. after approximately 6 months.