Pain Management Associated With the Insertion of Jaydess® in Nulliparous Women

Phase 4

• Conditions: IUD Insertion Complication
• Interventions: Behavioral: Verbal anesthesia; Drug: Tramadol; Device: Jaydess

• Registration Number: NCT02706509
• Lead Sponsor: Meir Medical Center

Brief Summary

A multicenter prospective interventional comparative study that investigate pain management during Jaydess insertion in nulliparous women that will be tested by the analgesic affects of oral tramadol or 'verbal anesthesia' on the patients.

Detailed Description

Most intrauterine contraception (IUC) insertions do not require pain management. However, small proportions of nulliparous women experience substantial pain that needs to be proactively managed No prophylactic pharmacological intervention has been adequately evaluated to support routine use for pain reduction during or after IUC insertion. Women's anxiety about the procedure may contribute to higher levels of perceived pain, which highlights the importance of counselling, and creating a trustworthy, unhurried and professional atmosphere in which the experience of the provider also has a major role; a situation frequently referred to as 'verbal anaesthesia'.

It has been proven in the past that the use of oral Tramadol can reduce the pain in the insertion.

In the study investigators will compare the analgesic affects of oral Tramadol and verbal anesthesia on pain relief during Jaydess insertion in nulliparous women.

Study Timeline

• Status Verified: 2016-02
• Study First Submitted: 2016-02-17
• Study Start: 2016-03
• Study First Submitted QC: 2016-03-10
• Last Update Submitted: 2016-03-10
• Study First Posted: 2016-03-11
• Last Update Posted: 2016-03-11
• Primary Completion: 2017-09
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Nulliparous women aged 18-48 years, interested in a long acting, reversible contraception method. Each read and signed the informed consent.

Exclusion Criteria

Women suffering from:

• Acute or recurrent pelvic inflammatory disease.

• Acute cervicitis or acute Vaginitis.

• Current cervical intraepithelial lesion.

• Current any genital malignancy.

• Progesterone hypersensitivity.

• progesterone-sensitive tumours (e.g. breast tumours).

• Abnormal vaginal bleeding.

• Congenital or acquired uterine anomaly.

• Distorted uterine cavity e.g. fibroid or polyp.

• Impaired liver functions, or liver tumour.

• Known hypersensitivity to the active substance or to any of the excipients of Jaydess.

• Contraindications to Tramadol according to approved product information:

  • In hypersensitivity to tramadol or any of the excipients.
  • In patients who are receiving monoamine oxidase inhibitors or within 2 weeks (14 days) of their withdrawal.
  • In patients with epilepsy not adequately controlled by treatment.

• Vaginismus.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oral tramadol	Jaydess	Patients will receive oral Tramadol 50 mg capsules (n=50)' . After an hour, Jaydess intrauterine device will be inserted.
verbal anesthesia	Verbal anesthesia	'verbal anesthesia' (n=50) After an hour, Jaydess intrauterine device will be inserted
oral tramadol	Tramadol	Patients will receive oral Tramadol 50 mg capsules (n=50)' . After an hour, Jaydess intrauterine device will be inserted.
verbal anesthesia	Jaydess	'verbal anesthesia' (n=50) After an hour, Jaydess intrauterine device will be inserted

Primary Outcome Measures

Name	Time	Method
Evaluation of pre-insertion therapy (oral analgesia and oral Tramadol) as pain management during insertion of Jaydess measured on a VAS (0-100 mm).	Day of insertion	The primary outcome will be the patient evaluation of pain during the procedure. The patient will be asked to assess the pain according to VAS scale (10-100 mm) 10 minutes after the insertion of Jaydess intrauterine device.

Secondary Outcome Measures

Name	Time	Method
Evaluation of pain during menstruation one month after the insertion of Jaydess intrauterine device	one month after insertion	The patient will be asked to asses the severity of pain during menstruation one month after the insertion of Jaydess intrauterine device according to VAS scale (1-100 mm)
Evaluation of pain during menstruation six month after the insertion of Jaydess	six month after insertion	The patient will be asked to asses the severity of pain during menstruation six month after the insertion of Jaydess intrauterine device according to VAS scale (1-100 mm)
Evaluation of the amount of bleeding during menstruation six month after the insertion of Jaydess intrauterine device	six month after insertion	The patient will be asked to asses the amount of bleeding during menstruation six month after the insertion of Jaydess intrauterine device according to a verbal scale (non, minor, medium, sever, very sever)
Evaluation of the amount of bleeding during menstruation one month after the insertion of Jaydess intrauterine device	one month after insertion	The patient will be asked to asses the amount of bleeding during menstruation one month after the insertion of Jaydess intrauterine device according to a verbal scale (non, minor, medium, sever, very sever)