Self-Administered Lidocaine Gel for Pain Management With IUD Insertion

Self-Administered Lidocaine Gel for Pain Management With IUD Insertion: A Randomized Controlled Trial

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02738203

Acronym

SALUD

Enrollment

220

Registered

2016-04-14

Start date

2016-06-01

Completion date

2017-10-19

Last updated

2019-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IUD Insertion

Keywords

Pain Management, IUD insertion

Brief summary

For intrauterine device (IUD) insertion, currently there are no standardized clinical guidelines for pain management. The investigators aim to explore whether adequate pain relief is possible through self-administered, non-invasive means alone. Reducing pain associated with IUD insertion may benefit patients and providers. When patients are comfortable during their procedure, it is likely the provider can more quickly and with fewer complications perform the insertion. The investigators propose to explore the effect of a locally applied vaginal lidocaine gel in place of the standard of care pain management, no intervention, prior to IUD insertions. This is a superiority, blinded, randomized controlled trial.

Interventions

DRUGVaginal 2% Lidocaine

Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly

DRUGSurgical Lubricant Jelly

Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

Elective IUD insertion (any type of IUD, copper or hormonal); at an out-patient setting at Stanford; English or Spanish speaking, and ability to give informed consent.

Exclusion criteria

Any pre-operative use of misoprostol; or use of PO pain control medication (i.e. ibuprofen or acetaminophen) prior to procedure. Allergy to study medications: lidocaine, or surgical lubricant jelly, known uterine anomaly; prior cervical surgery; and no prior use of tampons.

Design outcomes

Primary

Measure	Time frame	Description
(IUD Insertion): Pain Perceived by Visual Analogue Scale (0-100 mm) Immediately Following Procedure Completion	0-3 minutes after procedure completed	Pain immediately after speculum removal as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale 0 had no pain and 100 had worst pain imaginable as anchors. A higher score indicates higher pain.

Secondary

Measure	Time frame	Description
Anticipated Pain as Measured by a Visual Analog Scale	30 Minutes prior to procedure	Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale 0 had no pain and 100 had worst pain imaginable as anchors. A higher score indicates higher pain.
Baseline Pain as Measured by a Visual Analog Scale	Immediately prior to procedure; upon arrival to procedure room	Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale 0 had no pain and 100 had worst pain imaginable as anchors. A higher score indicates higher pain.
Pain After Speculum Placement as Measured by a Visual Analog Scale	Intraoperative	Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale 0 had no pain and 100 had worst pain imaginable as anchors. A higher score indicates higher pain.
Pain After Tenaculum Placement as Measured by a Visual Analog Scale	Intraoperative	Pain as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale 0 had no pain and 100 had worst pain imaginable as anchors. A higher score indicates higher pain.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Experimental, IUD Insertion Group If the subject is assigned to the experimental group (vaginal lidocaine jelly): She will be given a pre-filled vaginal inserter with 10 ml of 2% lidocaine jelly) and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo. Vaginal 2% Lidocaine: Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly	108
Control, IUD Insertion Group If the subject is assigned to the control group (sterile, surgical lubricant jelly): •She will be given a pre-filled vaginal inserter with 10 ml of surgical lubricant jelly and will be asked to insert it vaginally 20-30 minutes prior to the start of her procedure. The subject will not know if she received the active drug or a placebo. Surgical Lubricant Jelly: Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly	107
Total	215

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Failed IUD Insertion	2	2
Overall Study	Protocol Violation	0	1

Baseline characteristics

Characteristic	Experimental, IUD Insertion Group	Control, IUD Insertion Group	Total
Age, Continuous	28.9 years	27 years	28 years
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants	15 Participants	29 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	93 Participants	90 Participants	183 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants	2 Participants	3 Participants
Previous Intrauterine Device Insertion	37 Participants	33 Participants	70 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants	0 Participants	1 Participants
Race (NIH/OMB) Asian	14 Participants	17 Participants	31 Participants
Race (NIH/OMB) Black or African American	5 Participants	5 Participants	10 Participants
Race (NIH/OMB) More than one race	9 Participants	6 Participants	15 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants	3 Participants	4 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants	9 Participants	18 Participants
Race (NIH/OMB) White	69 Participants	67 Participants	136 Participants
Region of Enrollment United States	108 participants	107 participants	215 participants
Sex: Female, Male Female	108 Participants	107 Participants	215 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 / 108	0 / 107
other Total, other adverse events	0 / 108	0 / 107
serious Total, serious adverse events	0 / 108	0 / 107

Outcome results

Primary

(IUD Insertion): Pain Perceived by Visual Analogue Scale (0-100 mm) Immediately Following Procedure Completion

Pain immediately after speculum removal as measured by a Visual Analog Scale (VAS). This scale is 0-100--on the scale 0 had no pain and 100 had worst pain imaginable as anchors. A higher score indicates higher pain.

Time frame: 0-3 minutes after procedure completed