Pain Due to Intrauterine Contraceptive Device
Conditions
Keywords
Contraception, Pain, Intrauterine Device, Paracervical Block
Brief summary
Intrauterine device (IUD) placement can be painful for patients during and after the procedure. Fear of pain from IUD insertion can be a barrier to obtaining this highly effective long acting reversible contraception. Currently there are no proven effective methods for reduction of pain during and after placement of modern IUDs. Paracervical block pain may decrease this placement pain.
Detailed description
Modern IUDs are highly effective long acting reversible forms of contraception. The Mirena IUD is 99.8% effective and the Paragard copper IUD is 99.2% effective in preventing pregnancy. Fear of IUD placement can be a barrier to obtaining this highly effective form of birth control. The current standard of care for pain management during and after IUD placement is no medication, as randomized control trials published to date have limited data regarding use of medications to decrease pain. There has been one trial to suggest that the use of naproxen with 1% lidocaine paracervical block (PCB) compared to PCB alone may decrease pain after IUD placement in primarily nulliparous patients. However, this study was with the much wider and no longer available Dalkon Shield IUD. In addition, this study did not show any significant decrease in pain scores during IUD placement. Studies to evaluate effectiveness of ibuprofen and misoprostol have shown no significant decrease in pain scores during and after IUD insertion, although the majority of participants in these studies were multiparous. There is some suggestion that 2% lidocaine gel one minute prior to IUD insertion may have some decrease in pain, although this study was poorly designed. Although there is no standard of care in regards to pain medication administration prior to IUD placement, providers often suggest paracervical prior IUD insertion among nulliparous women. Therefore the primary aim of this study is to determine whether a paracervical block (PCB) decreases pain associated with intrauterine device (IUD) placement compared to no paracervical block. We hypothesize that administration of a PCB of 20 mL 1% buffered lidocaine prior to IUD placement will decrease pain scores by at least 20mm on a visual analog scale at various time points during IUD placement when compared to no paracervical block.
Interventions
PROCEDUREParacervical Block (PCB)
Drug: 1% Lidocaine Hydrochloride Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix and 18 mL 1% buffered lidocaine solution evenly distributed between 4 o'clock and 8 o'clock positions of cervix with standard 22 gauge spinal needle. IUD placement then proceeds
PROCEDURENo Paracervical Block (Sham PCB)
Drug: 1% Lidocaine Hydrochloride Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix with standard 22 gauge spinal needle. Capped spinal needle is then held against the cervix at 4 o'clock and 8 o'clock positions of cervix, lightly so as not to cause blanching, indentation, or pain. IUD placement then proceeds
Sponsors
University of California, San Diego
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Nulliparous women * English or Spanish speaking * Present for intrauterine device placement for contraception or menorrhagia (in the case of Mirena IUD insertion).
Exclusion criteria
* Pregnancy * Any diagnosed chronic pain issues (i.e. fibromyalgia, endometriosis, dysmenorrhea, irritable bowel syndrome, interstitial cystitis) * If the patient has taken any pain medications within 6 hours of enrollment, including aspirin or other NSAIDs * Misoprostol administration within 24 hours of enrollment * History of prior IUD insertion * Known contraindications to IUD
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain With Intrauterine Device (IUD) Placement | Moment of IUD insertion | Distance (mm) from the left of the 100-mm visual analog scale (reflecting magnitude of pain) recorded at time of IUD Placement. Scale range is from 0mm (no pain) to 100mm (worst pain possible). A lower score (less pain) is considered a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Median Pain Scores for All Time Points | Anticipation of procedure through 5 minutes after IUD placement | Distance (mm) from the left of the 100-mm visual analog scale of pain at various time points. Scale range is 0mm (no pain) to 100mm (worst pain possible). Lower scores are considered better outcomes. |
Countries
United States
Participant flow
Recruitment details
Inclusion: Nulliparous women, 18-45, requesting IUD, seen in our clinic from October 2014 through October 2017 Exclusion: pregnancy, diagnosed chronic pain issues, use of pain medication within 6 hours, misoprostol administration within 24 hours, history of prior IUD placement, known contraindications to IUD placement.
Participants by arm
| Arm | Count |
|---|---|
| No Paracervical Block (Sham PCB) Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed.
Subject then receives Sham paracervical block with capped needle. Provider then places IUD.
No Paracervical Block (Sham PCB): Drug: 1% Lidocaine Hydrochloride
Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix with standard 22 gauge spinal needle. Capped spinal needle is then held against the cervix at 4 o'clock and 8 o'clock positions of cervix, lightly so as not to cause blanching, indentation, or pain.
IUD placement then proceeds | 31 |
| Paracervical Block (PCB) Subject receives 2 mL 1% buffered Lidocaine anesthetic at anterior lip of cervix, where tenaculum will be placed.
Subject then receives paracervical block of 18 mL 1% buffered Lidocaine. Provider then places IUD.
Paracervical Block (PCB): Drug: 1% Lidocaine Hydrochloride
Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix and 18 mL 1% buffered lidocaine solution evenly distributed between 4 o'clock and 8 o'clock positions of cervix with standard 22 gauge spinal needle.
IUD placement then proceeds | 33 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 2 |
Baseline characteristics
| Characteristic | No Paracervical Block (Sham PCB) | Total | Paracervical Block (PCB) |
|---|---|---|---|
| Age, Continuous | 24.8 years STANDARD_DEVIATION 3.4 | 25.45 years STANDARD_DEVIATION 3.5 | 26.1 years STANDARD_DEVIATION 3.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 14 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants | 49 Participants | 26 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 11 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 8 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 20 Participants | 41 Participants | 21 Participants |
| Region of Enrollment United States | 31 Participants | 64 Participants | 33 Participants |
| Sex: Female, Male Female | 31 Participants | 64 Participants | 33 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 | 0 / 31 | 0 / 33 |
| other Total, other adverse events | 0 / 31 | 0 / 33 |
| serious Total, serious adverse events | 0 / 31 | 0 / 33 |
Outcome results
Primary
Pain With Intrauterine Device (IUD) Placement
Distance (mm) from the left of the 100-mm visual analog scale (reflecting magnitude of pain) recorded at time of IUD Placement. Scale range is from 0mm (no pain) to 100mm (worst pain possible). A lower score (less pain) is considered a better outcome.
Time frame: Moment of IUD insertion
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| No Paracervical Block (Sham PCB) | Pain With Intrauterine Device (IUD) Placement | 54 mm |
| Paracervical Block (PCB) | Pain With Intrauterine Device (IUD) Placement | 33 mm |
Secondary
Median Pain Scores for All Time Points
Distance (mm) from the left of the 100-mm visual analog scale of pain at various time points. Scale range is 0mm (no pain) to 100mm (worst pain possible). Lower scores are considered better outcomes.
Time frame: Anticipation of procedure through 5 minutes after IUD placement
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| No Paracervical Block (Sham PCB) | Median Pain Scores for All Time Points | Anticipated Pain | 51 mm |
| No Paracervical Block (Sham PCB) | Median Pain Scores for All Time Points | Baseline Pain | 0 mm |
| No Paracervical Block (Sham PCB) | Median Pain Scores for All Time Points | Speculum Insertion | 6 mm |
| No Paracervical Block (Sham PCB) | Median Pain Scores for All Time Points | Capped Needle or PCB | 8 mm |
| No Paracervical Block (Sham PCB) | Median Pain Scores for All Time Points | Tenaculum placement | 10 mm |
| No Paracervical Block (Sham PCB) | Median Pain Scores for All Time Points | Uterine Sounding | 47 mm |
| No Paracervical Block (Sham PCB) | Median Pain Scores for All Time Points | IUD placement | 54 mm |
| No Paracervical Block (Sham PCB) | Median Pain Scores for All Time Points | 5 mins after IUD placement | 27 mm |
| No Paracervical Block (Sham PCB) | Median Pain Scores for All Time Points | Overall pain | 51 mm |
| Paracervical Block (PCB) | Median Pain Scores for All Time Points | 5 mins after IUD placement | 12 mm |
| Paracervical Block (PCB) | Median Pain Scores for All Time Points | Uterine Sounding | 30 mm |
| Paracervical Block (PCB) | Median Pain Scores for All Time Points | Baseline Pain | 0 mm |
| Paracervical Block (PCB) | Median Pain Scores for All Time Points | Anticipated Pain | 58 mm |
| Paracervical Block (PCB) | Median Pain Scores for All Time Points | Speculum Insertion | 10 mm |
| Paracervical Block (PCB) | Median Pain Scores for All Time Points | IUD placement | 33 mm |
| Paracervical Block (PCB) | Median Pain Scores for All Time Points | Capped Needle or PCB | 30 mm |
| Paracervical Block (PCB) | Median Pain Scores for All Time Points | Overall pain | 30 mm |
| Paracervical Block (PCB) | Median Pain Scores for All Time Points | Tenaculum placement | 15 mm |