Menstrual Cycle on Injection Pain of Rocuronium

Not Applicable

Completed

• Conditions: Pain, Menstrual
• Interventions: Drug: Rocuronium 0,6mg/kg

• Registration Number: NCT02539706
• Lead Sponsor: Aydin Adnan Menderes University

Brief Summary

This study evaluates the effects of rocuronium injection pain to menstrual cycle phases.Half of participants will receive follicular phase, while the other half will receive luteal phase.

Detailed Description

Menstrual period includes a spectrum of emotional and somatic symptoms observed in luteal phase of menstrual cycle, which are disappeared after menstruation.

During menstrual cycle, fluctuation in sexual hormones results in attitude change and alteration in pain perception.

Different studies reported some interactions between sex hormones and central nervous system, which might be linked to activity of serotonin and beta-endorphin in the brain.

Pain perception differs during menstrual cycle.

It has been recommended that estrogens might have an influence on somatic sensory process.

Some studies reported a significant effect of pain sensitivity with higher levels of progesterone and some other studies reported similar patterns for pain perception.

There are reports of more complaint of pain in luteal phase of menstruation, which is suggested as the reason for functional changes in women during menstrual cycle.

Study Timeline

• Study Start: 2014-01-06
• Study First Submitted: 2015-09-01
• Study First Submitted QC: 2015-09-01
• Study First Posted: 2015-09-03
• Primary Completion: 2015-09-06
• Study Completion: 2015-10-06
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-28
• Last Update Posted: 2017-11-29

Recruitment & Eligibility

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

Inclusion Criteria

• American Society of Anesthesiology Classification (ASA) I-II
• 18-45 years
• Regular menstrual cycle

Exclusion Criteria

• Irregular menstrual cycles
• Patients receiving hormones or drugs affecting the ovulatory cycle
• Amenorrhea
• Pregnancy
• Climacteric patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Follıcular group	Rocuronium 0,6mg/kg	patients at days 8 to 14 of the menstrual cycle were considered to be at the follicular phase and Rocuronium 0,6mg/kg intravenous rocuronium was applied.
Luteal group	Rocuronium 0,6mg/kg	patients at days 18 to 24 of the menstrual cycle were considered to be at the luteal phase and Rocuronium 0,6mg/kg intravenous rocuronium was applied.

Primary Outcome Measures

Name	Time	Method
Pain measure	10 second	Tracheal intubating dose of 0.6 mg/kg of rocuronium at room temperature was injected over 10 -15 s. The patients were observed immediately if they had pain in the arm, and the response was assessed. Withdrawal movements were also assessed and scored as follows: no movements = 0, movement limited to hand = 1, movement limited to the forearm including the elbow joint = 2, and movement of the upper arm including the shoulder joint = 3

Trial Locations

Locations (1)

Adnan Menderes University Training and Research Hospital; 🇹🇷 Aydın, Turkey