Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Region Stockholm | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pertubation with Endole® (lignocaine) | Experimental | Three treatments were to be given preovulatory at cycle day 6-12 in three sequential menstrual cycles. |
|
| Placebo | Placebo Comparator | Pertubation with Ringer solution, given preovulatory at cycle day 6-12 in three sequential menstrual cycles. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lignocaine | Drug | Intrauterine flushing, pertubation, three treatments given preovulatory at cycle day 6-12 in three sequential menstrual cycles. |
|
| 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 |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Karin Wickström, MD | Danderyd Hospital, SE-182 88 Stockholm, Sweden | Principal Investigator |
| Greta Edelstam, MD | Karolinska University Hospital at Huddinge SE-141 86 Stockholm, Sweden | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Läkargruppen Victoria Söderhallarna 120 | Stockholm | Stockholm County | 118 72 | Sweden | ||
| Karolinska Institute, Fertility Unit, K59 Karolinska University Hospital at Huddinge |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28844356 | Derived | 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. | |
| 23921822 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D004715 | Endometriosis |
| D004412 | Dysmenorrhea |
| D017699 | Pelvic Pain |
| D004414 | Dyspareunia |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D000077331 | Ringer's Solution |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Ringers Solution | Drug | Intrauterine flushing, pertubation, given preovulatory at cycle day 6-12 in three sequential menstrual cycles. |
|
| Stockholm |
| Stockholm County |
| 141 86 |
| Sweden |
| Department of Gynaecology and Obstetrics Danderyd Hospital | Stockholm | Stockholm County | 182 88 | Sweden |
| 22232129 | Derived | 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. |
| D000091662 | Genital Diseases |
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D005832 | Genital Diseases, Male |
| D012735 | Sexual Dysfunction, Physiological |
| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |
| Aniline Compounds |
| D000588 | Amines |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |