Pertubation With Lignocaine in Endometriosis

Study Overview
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Brief Summary
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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.

Official Title
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Pertubation With Lignocaine in Endometriosis Associated Symptoms Effect Study

Conditions
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Endometriosis, Dysmenorrhea

Intervention / Treatment
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* Drug: Lignocaine
* Drug: Ringers Solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pertubation with Endole® (lignocaine)<br>Three treatments were to be given preovulatory at cycle day 6-12 in three sequential menstrual cycles. | Drug: Lignocaine<br>* Intrauterine flushing, pertubation, three treatments given preovulatory at cycle day 6-12 in three sequential menstrual cycles.<br>* Other names: Lidocaine;|
| Placebo Comparator: Placebo<br>Pertubation with Ringer solution, given preovulatory at cycle day 6-12 in three sequential menstrual cycles. | Drug: Ringers Solution<br>* Intrauterine flushing, pertubation, given preovulatory at cycle day 6-12 in three sequential menstrual cycles.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | After three pertubations | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | At the 7th menstruation i.e. after approximately 6 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dysmenorrhea,, pelvic pain, dyspareunia, endometriosis