Trial Outcomes & Findings for Tenaculum Pain Control Study (NCT NCT01421641)

Results Overview

The primary outcome was pain at the time of tenaculum placement. Patient asked to pain scale using 100mm Visual Analog Scale (0mm=no pain, 100mm=worst pain of my life) during after tenaculum placement.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

74 participants

Primary outcome timeframe

After tenaculum placement

Results posted on

2014-04-21

Participant Flow

We conducted a randomized, single-blinded clinical trial from August 2011 to May 2012 at the Center for Women's Health at Oregon Health \& Science University (OHSU; Portland, Oregon).We recruited women aged 18 years and older who were scheduled to undergo IUD placement or endometrial biopsy.

Exclusion criteria included 1) allergy to lidocaine or other local anesthetics; 2) pregnancy; 3) patients pre-medicated with misoprostol; and 4) patients with a chronic pain condition for which they were taking daily pain medications of any kind. The subjects were recruited, consented, and enrolled immediately prior to the procedure.

Participant milestones

Participant milestones
Measure	Intracervical Lidocaine Injection Intracervical Lidocaine Injection : Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle	Topical Lidocaine Gel Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
Overall Study STARTED	37	37
Overall Study COMPLETED	35	35
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Intracervical Lidocaine Injection Intracervical Lidocaine Injection : Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle	Topical Lidocaine Gel Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
Overall Study Protocol Violation	2	2

Baseline Characteristics

Tenaculum Pain Control Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intracervical Lidocaine Injection n=37 Participants Intracervical Lidocaine Injection : Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle	Topical Lidocaine Gel n=37 Participants Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip	Total n=74 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=5 Participants	37 Participants n=7 Participants	74 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	34.6 years STANDARD_DEVIATION 12.2 • n=5 Participants	33.7 years STANDARD_DEVIATION 7.3 • n=7 Participants	34.5 years STANDARD_DEVIATION 9.9 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	37 Participants n=7 Participants	74 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	37 participants n=5 Participants	37 participants n=7 Participants	74 participants n=5 Participants

PRIMARY outcome

Timeframe: After tenaculum placement

Population: 4 subjects were excluded due to protocol violations

The primary outcome was pain at the time of tenaculum placement. Patient asked to pain scale using 100mm Visual Analog Scale (0mm=no pain, 100mm=worst pain of my life) during after tenaculum placement.

Outcome measures

Outcome measures
Measure	Intracervical Lidocaine Injection n=35 Participants Intracervical Lidocaine Injection : Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle	Topical Lidocaine Gel n=35 Participants Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
Tenaculum Pain	12.3 mm Standard Deviation 17.4	36.6 mm Standard Deviation 23.0

SECONDARY outcome

Timeframe: after application of randomized intervention

Pain with the intervention (injection or gel application). Subjects are asked to complete pain scale using a 100mm Visual Analog Scale (0mm=no pain and 100mm=worst pain of my life)

Outcome measures

Outcome measures
Measure	Intracervical Lidocaine Injection n=35 Participants Intracervical Lidocaine Injection : Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle	Topical Lidocaine Gel n=35 Participants Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
Intervention Pain	20.4 mm Standard Deviation 19.4	5.9 mm Standard Deviation 8.6

SECONDARY outcome

Timeframe: After placement of the tenaculum

Satisfaction with overall tenaculum placement procedure. Subjects asked to answer their overall satisfaction with the pain control. Subjects asked to complete 100mm Visual Analog Scale (0mm=not at all satisfied to 100mm=very satisfied)

Outcome measures

Outcome measures
Measure	Intracervical Lidocaine Injection n=35 Participants Intracervical Lidocaine Injection : Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle	Topical Lidocaine Gel n=35 Participants Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
Tenaculum Placement Satisfaction	79.9 mm Standard Deviation 22.7	74.6 mm Standard Deviation 27.6

Adverse Events

Intracervical Lidocaine Injection

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Topical Lidocaine Gel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intracervical Lidocaine Injection n=37 participants at risk Intracervical Lidocaine Injection : Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle	Topical Lidocaine Gel n=37 participants at risk Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
Nervous system disorders vasovagal reaction	2.7% 1/37 • Number of events 1	0.00% 0/36

Additional Information

Paula Bednarek

Oregon Health & Science University

Phone: (503) 418-4500

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place