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Completed

NCT Number: NCT01329796

Pertubation With Lignocaine in Endometriosis

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.

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Key information

Conditions

Endometriosis Dysmenorrhea Dyspareunia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Male Urogenital Diseases Menstruation Disturbances Mental Disorders Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Signs and Symptoms Urogenital Diseases

Age range

21 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Department of Gynaecology and Obstetrics Danderyd Hospital, Stockholm, Stockholm County, Sweden

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lignocaine

Drug

Intrauterine flushing, pertubation, three treatments given preovulatory at cycle day 6-12 in three sequential menstrual cycles.

Other names: Lidocaine

Ringers Solution

Drug

Intrauterine flushing, pertubation, given preovulatory at cycle day 6-12 in three sequential menstrual cycles.

Primary outcomes

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

    Time frame: After three pertubations

    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.

Secondary outcomes

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

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

    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.

Sponsors and collaborators

Lead sponsor

Isifer AB

Industry

Collaborators

  • Region Stockholm

Registry information

Official study title

Pertubation With Lignocaine in Endometriosis Associated Symptoms Effect Study

Acronym: PLEASE

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Apr 6, 2011
Registry last updated
Apr 6, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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