Cervical Pain, Pelvic Pain
Conditions
Keywords
Tenaculum, Pain, Lidocaine
Brief summary
The purpose of this clinical trial is to evaluate the effect of an intracervical lidocaine injection versus topical lidocaine gel on the pain experienced by patients undergoing tenaculum application to the cervix during office gynecologic procedures. This study will also evaluate how satisfied women are with the method of pain control used. The researchers hypothesize that: 1. There is less pain perceived by patients undergoing placement of a tenaculum on the cervix when a lidocaine injection is used compared to a topical lidocaine gel. 2. Patients are more satisfied with pain control during the overall experience of undergoing tenaculum placement on the cervix when a lidocaine injection is used compared to a topical lidocaine gel.
Detailed description
Subjects who have already scheduled an IUD insertion or endometrial biopsy will be asked to join this study assessing two pain control interventions at the time of tenaculum application to the cervix during office gynecologic procedures. Only healthy women ages 18 and over with an indication for endometrial biopsy or IUD placement will be recruited. The participants will be randomized to one of two arms: an intracervical lidocaine injection versus topical lidocaine gel. They will be asked to indicate their level of pain and level of satisfaction using a Visual Analog Scale. The primary outcome, pain with tenaculum placement, and the secondary outcome, satisfaction with the experience of tenaculum placement, will be compared between the study groups.
Interventions
DRUGIntracervical Lidocaine Injection
Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle
DRUGTopical Lidocaine Gel
Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
Sponsors
Oregon Health and Science University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Generally healthy women * Age 18 and over * Indication for endometrial biopsy or IUD placement
Exclusion criteria
* Allergy to lidocaine or other local anesthetic * Pregnancy, known or suspected * Patients who are premedicated with misoprostol * Patients with a chronic pain condition for which the patient takes daily pain medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tenaculum Pain | After tenaculum placement | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intervention Pain | 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) |
| Tenaculum Placement Satisfaction | 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) |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 37 |
| Topical Lidocaine Gel Topical Lidocaine Gel : Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip | 37 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 2 | 2 |
Baseline characteristics
| Characteristic | Topical Lidocaine Gel | Intracervical Lidocaine Injection | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 37 Participants | 37 Participants | 74 Participants |
| Age, Continuous | 33.7 years STANDARD_DEVIATION 7.3 | 34.6 years STANDARD_DEVIATION 12.2 | 34.5 years STANDARD_DEVIATION 9.9 |
| Region of Enrollment United States | 37 participants | 37 participants | 74 participants |
| Sex: Female, Male Female | 37 Participants | 37 Participants | 74 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 1 / 37 | 0 / 37 |
| serious Total, serious adverse events | 0 / 37 | 0 / 37 |
Outcome results
Primary
Tenaculum Pain
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.
Time frame: After tenaculum placement
Population: 4 subjects were excluded due to protocol violations
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intracervical Lidocaine Injection | Tenaculum Pain | 12.3 mm | Standard Deviation 17.4 |
| Topical Lidocaine Gel | Tenaculum Pain | 36.6 mm | Standard Deviation 23 |
Secondary
Intervention Pain
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)
Time frame: after application of randomized intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intracervical Lidocaine Injection | Intervention Pain | 20.4 mm | Standard Deviation 19.4 |
| Topical Lidocaine Gel | Intervention Pain | 5.9 mm | Standard Deviation 8.6 |
Secondary
Tenaculum Placement Satisfaction
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)
Time frame: After placement of the tenaculum
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intracervical Lidocaine Injection | Tenaculum Placement Satisfaction | 79.9 mm | Standard Deviation 22.7 |
| Topical Lidocaine Gel | Tenaculum Placement Satisfaction | 74.6 mm | Standard Deviation 27.6 |