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Trial Outcomes & Findings for Paracervical Block During Office Hysteroscopy (NCT NCT00811187)

NCT ID: NCT00811187

Last Updated: 2019-12-11

Results Overview

This used a visual analog scale from 0 (minimum) to 10 (maximum) that was measured as centimeters. A higher score would indicate more pain, therefore, a worse outcome. Pain was assessed at each step that could potentially elicit pain, specifically when there was direct physical manipulation.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

80 participants

Primary outcome timeframe

During Procedure

Results posted on

2019-12-11

Participant Flow

This was a investigator-sponsored single site clinical trial. Patients were recruited based on physician referral at Montefiore Medical Center from March 2007 to June 2008. Patients were excluded from participation if they had a known allergy to lidocaine.

Of the 80 patients that met inclusion and exclusion criteria, only 74 completed either the lidocaine or saline placebo single-injection. Patients were randomized 1:1.

Participant milestones

Participant milestones
Measure
Lidocaine Paracervical Block
10 cc of 1% Lidocaine (10mg) injected in the paracervical region of patient as a single-injection nerve block before their procedure.
Saline Placebo Injection
10 cc of Normal Saline (10mg) as placebo injected in paracervical region of patient as a single-injection placebo before their procedure.
Overall Study
STARTED
40
40
Overall Study
COMPLETED
37
37
Overall Study
NOT COMPLETED
3
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Lidocaine Paracervical Block
10 cc of 1% Lidocaine (10mg) injected in the paracervical region of patient as a single-injection nerve block before their procedure.
Saline Placebo Injection
10 cc of Normal Saline (10mg) as placebo injected in paracervical region of patient as a single-injection placebo before their procedure.
Overall Study
Unable to place device / procedure abort
3
3

Baseline Characteristics

Paracervical Block During Office Hysteroscopy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Lidocaine Paracervical Block
n=40 Participants
10 cc of 1% Lidocaine injected in the paracervical region
Saline Placebo Injection
n=40 Participants
10 cc of Normal Saline as placebo injected in paracervical region
Total
n=80 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
40 Participants
n=5 Participants
40 Participants
n=7 Participants
80 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
34.2 years
STANDARD_DEVIATION 4.5 • n=5 Participants
36.4 years
STANDARD_DEVIATION 4.1 • n=7 Participants
35 years
STANDARD_DEVIATION 4 • n=5 Participants
Sex: Female, Male
Female
40 Participants
n=5 Participants
40 Participants
n=7 Participants
80 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
40 participants
n=5 Participants
40 participants
n=7 Participants
80 participants
n=5 Participants

PRIMARY outcome

Timeframe: During Procedure

Population: Intent to Treat Population (all participants assigned to lidocaine or saline).

This used a visual analog scale from 0 (minimum) to 10 (maximum) that was measured as centimeters. A higher score would indicate more pain, therefore, a worse outcome. Pain was assessed at each step that could potentially elicit pain, specifically when there was direct physical manipulation.

Outcome measures

Outcome measures
Measure
Lidocaine Group
n=37 Participants
10 cc 1% lidocaine injected in the paracervical region
Saline Placebo Group
n=37 Participants
10 cc of 1% lidocaine injected in the paracervical region
Assessment of Pain on a 10-point Visual Analog Pain Scale During the Procedure.
4.15 Score on a scale
Standard Deviation 1.9
3.38 Score on a scale
Standard Deviation 5.84

Adverse Events

Lidocaine Paracervical Block

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Saline Placebo Injection

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

Research Program Administrator

Montefiore Medical Center

Phone: 718-405-8526

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place