Trial Outcomes & Findings for The Impact of Pain Scores on Intrauterine Lidocaine Versus Normal Saline Infusion at the Time of IUD Placement (NCT NCT01311102)

Results Overview

Pain score on 0-9 scale obtained just before the patient left the examination room; with 0 being "no pain" and 9 being "worst pain in life."

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

40 participants

Primary outcome timeframe

Before patient left the examination room at conclusion of procedure

Results posted on

2014-02-05

Participant Flow

Participant milestones

Participant milestones
Measure	Lidocaine Lidocaine : 1.33 cc of 2% liquid lidocaine	Normal Saline Normal Saline : 1.33cc of normal saline
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Impact of Pain Scores on Intrauterine Lidocaine Versus Normal Saline Infusion at the Time of IUD Placement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lidocaine n=20 Participants Lidocaine : 1.33cc of 2% liquid lidocaine	Normal Saline n=20 Participants Normal Saline : 1.33cc of normal saline	Total n=40 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	20 Participants n=5 Participants	20 Participants n=7 Participants	40 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 Age Range	32.05 years FULL_RANGE Not reported • n=5 Participants	32.06 years FULL_RANGE Not reported • n=7 Participants	32.055 years FULL_RANGE Not reported • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	20 Participants n=7 Participants	40 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	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants

PRIMARY outcome

Timeframe: Before patient left the examination room at conclusion of procedure

Pain score on 0-9 scale obtained just before the patient left the examination room; with 0 being "no pain" and 9 being "worst pain in life."

Outcome measures

Outcome measures
Measure	Lidocaine n=20 Participants Lidocaine : 1.33cc of 2% liquid lidocaine	Normal Saline n=20 Participants Normal Saline : 1.33cc of normal saline
Pain Scores During Overall IUD Placement	2.12 units on a scale of 0-9 Standard Deviation 2.32 • Interval 0.0 to 9.0	1.73 units on a scale of 0-9 Standard Deviation 1.49 • Interval 0.0 to 9.0

PRIMARY outcome

Timeframe: Immediately following tenaculum placement

Pain score on 0-9 scale for tenaculum placement (without anesthesia); with 0 being "no pain" and 9 being "worst pain in life." Taken to adjust for different pain thresholds among subjects

Outcome measures

Outcome measures
Measure	Lidocaine n=20 Participants Lidocaine : 1.33cc of 2% liquid lidocaine	Normal Saline n=20 Participants Normal Saline : 1.33cc of normal saline
Pain During Tenaculum Placement	2.20 units on a scale of 0-9 Standard Deviation 2.42	2.70 units on a scale of 0-9 Standard Deviation 2.03

PRIMARY outcome

Timeframe: Recorded at the end of the infusion

After liquid infused into three parts of the endometrial cavity: in the lower one third, the middle, and at the top of the cavity. Pain was scored on a 0-9 scale; with 0 being "no pain" and 9 being "worst pain in life."

Outcome measures

Outcome measures
Measure	Lidocaine n=20 Participants Lidocaine : 1.33cc of 2% liquid lidocaine	Normal Saline n=20 Participants Normal Saline : 1.33cc of normal saline
Pain Measurement During Liquid Infusion/Sounding	2.50 units on a scale of 0-9 Standard Deviation 3.09	3.39 units on a scale of 0-9 Standard Deviation 3.16

PRIMARY outcome

Timeframe: Immediately after IUD placement

IUD was inserted following the manufacturer's instructions, and a pain score was immediately obtained. Pain was scored on 0-9 scale; with 0 being "no pain" and 9 being "worst pain in life."

Outcome measures

Outcome measures
Measure	Lidocaine n=20 Participants Lidocaine : 1.33cc of 2% liquid lidocaine	Normal Saline n=20 Participants Normal Saline : 1.33cc of normal saline
Pain During IUD Placement	2.95 units on a scale of 0-9 Standard Deviation 2.61	3.68 units on a scale of 0-9 Standard Deviation 2.71

Adverse Events

Lidocaine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Saline

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Anita Nelson

Harbor-UCLA Medical Center

Phone: 310-222-3871

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place