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Oral Gabapentin in Management of Chronic Pelvic Pain in Females: A Randomised Placebo-controlled Study.

Oral Gabapentin in Management of Chronic Pelvic Pain in Females: A Randomised Placebo-controlled Study.

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02918760
Enrollment
64
Registered
2016-09-29
Start date
2016-03-31
Completion date
Unknown
Last updated
2016-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Pain

Keywords

Gabapentin, chronic pelvic pain.

Brief summary

Aim :The aim of this study is to evaluate the efficacy of oral Gabapentin in the treatment of chronic pelvic pain in females. The study is designed as a randomised, placebo-controlled, clinical trial.32 patients will be enrolled each arm. Group A (cases): This group will include (32) women according to inclusion and exclusion criteria and will receive a card of Gabapentin which will be taken orally by the patient at home three times daily and maximum dose 2700mg per day by 300 mg increments each week until sufficient pain relief, or the occurrence of side effects such as dizziness, somnolence, edema and ataxia. Group B (controls):This group will include (32) women . Assessment of the patient's pain during the physical examination will be done using the Visual Analogue Scale (VAS). The patient will be asked to place a mark on a drawn 10 cm line at a point which is corresponding to the intensity of her pain. One end of the line denotes no pain and the other end of the line indicates that pain is as bad as it can be (the worst pain).the distance in cm from the low end of VAS to the patient's mark will be used (it gives a number.Questionnaire: will be given to all participants at randomization (0 months) , at 3 months and at 6 months to assess the degree of pain improvement via VAS. Patients' overall satisfaction with their pain treatment &Side effect recording (e.g., dizziness, somnolence, mood changes, appetite and poor concentration).

Interventions

DRUGGabapentin

This group will include (32) women according to inclusion and exclusion criteria and will receive a card of Gabapentin which will be taken orally by the patient at home three times daily and maximum dose 2700mg per day by 300 mg increments each week until sufficient pain relief, or the occurrence of side effects such as dizziness, somnolence, edema and ataxia.

OTHERPlacebo

Group B (controls):This group will include (32) women according to inclusion and exclusion criteria and will receive a card of placebo.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Moderate to severe chronic pelvic pain for at least 6 months. * Pain was unrelated exclusively to menstruation. * Pain incompletely relieved by Non-steroidal Ant-inflammatory drugs. * Patients had regular menstrual cycles for 3 months. * Patient receiving regular, effective contraceptive method.

Exclusion criteria

* Pregnancy or planning of pregnancy in next 6 months. * Breast feeding. * Acute pelvic infection. * Known history of hypersensitivity to Gabapentin. * Patients with severe renal or hepatic failure. * Women with previous diagnosis of endometriosis confirmed by laparoscopy. * Women with previous diagnosis of Malignancy. * Plans for surgery in next 6 months. * Women with chronic or recurrent gastrointestinal disease, including irritable bowel syndrome. * Women with histories of alcohol use or other chronic tranquilizers. Patients refuse to sign an informed consent form.

Design outcomes

Primary

MeasureTime frame
Pain score improvement6 months

Secondary

MeasureTime frame
Side effect recording6 months

Countries

Egypt

Contacts

Primary ContactMohamed Abdel hafeez, A.professor
dr_m.hafeez@hotmail.com002 01005016222
Backup ContactAhmed Elnaggar
draknaggar@yahoo.com00447797790230

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026