Trial Outcomes & Findings for Paracervical Block for Pain Control With Osmotic Dilator Placement (NCT NCT02354092)

Results Overview

Measure of distance (mm) from the left ("no pain") on the 100-mm visual analog scale (VAS - reflecting magnitude of pain) recorded at time immediately after osmotic dilator placement. 0 mm=No Pain and 100 mm= worst possible pain. A higher score indicates a higher level of pain.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

14 participants

Primary outcome timeframe

Within 5 minutes of PCB or sham procedure

Results posted on

2019-06-11

Participant Flow

Participant milestones

Participant milestones
Measure	Sham Group This non-intervention group will receive the sham paracervical block. This intervention will include * Preprocedural pain control: 800 mg Ibuprofen prior to dilator placement * Local anesthetic for tenaculum placement * Sham Paracervical Block done with capped spinal needle * osmotic dilators placed in the usual fashion * postprocedural assessment	Paracervical Block Group This intervention group will receive the paracervical block. This intervention will include * Preprocedural pain control: 800 mg Ibuprofen prior to dilator placement * Local anesthetic for tenaculum placement * 18 ml 1% buffered lidocaine Paracervical Block * osmotic dilators placed in the usual fashion * postprocedural assessment
Overall Study STARTED	7	7
Overall Study COMPLETED	7	7
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Paracervical Block for Pain Control With Osmotic Dilator Placement

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sham Group n=7 Participants This non-intervention group will receive the sham paracervical block. This intervention will include * Preprocedural pain control: 800 mg Ibuprofen prior to dilator placement * Local anesthetic for tenaculum placement * Sham Paracervical Block done with capped spinal needle * osmotic dilators placed in the usual fashion * postprocedural assessment	Paracervical Block Group n=7 Participants This intervention group will receive the paracervical block. This intervention will include * Preprocedural pain control: 800 mg Ibuprofen prior to dilator placement * Local anesthetic for tenaculum placement * 18 ml 1% buffered lidocaine Paracervical Block * osmotic dilators placed in the usual fashion * postprocedural assessment	Total n=14 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	7 Participants n=5 Participants	7 Participants n=7 Participants	14 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	23.0 years STANDARD_DEVIATION 4.3 • n=5 Participants	27.6 years STANDARD_DEVIATION 7.2 • n=7 Participants	25.3 years STANDARD_DEVIATION 6.2 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants	7 Participants n=7 Participants	14 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	7 participants n=5 Participants	7 participants n=7 Participants	14 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 5 minutes of PCB or sham procedure

Measure of distance (mm) from the left ("no pain") on the 100-mm visual analog scale (VAS - reflecting magnitude of pain) recorded at time immediately after osmotic dilator placement. 0 mm=No Pain and 100 mm= worst possible pain. A higher score indicates a higher level of pain.

Outcome measures

Outcome measures
Measure	Sham Group n=7 Participants This non-intervention group will receive the sham paracervical block. This intervention will include * Preprocedural pain control: 800 mg Ibuprofen prior to dilator placement * Local anesthetic for tenaculum placement * Sham Paracervical Block done with capped spinal needle * osmotic dilators placed in the usual fashion * postprocedural assessment	Paracervical Block Group n=7 Participants This intervention group will receive the paracervical block. This intervention will include * Preprocedural pain control: 800 mg Ibuprofen prior to dilator placement * Local anesthetic for tenaculum placement * 18 ml 1% buffered lidocaine Paracervical Block * osmotic dilators placed in the usual fashion * postprocedural assessment
Pain at Time of Osmotic Dilator Placement	46 units on a scale Standard Deviation 37	32 units on a scale Standard Deviation 30

SECONDARY outcome

Timeframe: Within 5 minutes after baseline

Measure of distance (mm) from the left ("no pain") on the 100-mm visual analog scale (VAS - reflecting magnitude of pain) recorded at time immediately after last injection for paracervical block OR script for sham injection. 0 mm=No Pain and 100 mm= worst possible pain. A higher score indicates a higher level of pain.

Outcome measures

Outcome measures
Measure	Sham Group n=7 Participants This non-intervention group will receive the sham paracervical block. This intervention will include * Preprocedural pain control: 800 mg Ibuprofen prior to dilator placement * Local anesthetic for tenaculum placement * Sham Paracervical Block done with capped spinal needle * osmotic dilators placed in the usual fashion * postprocedural assessment	Paracervical Block Group n=7 Participants This intervention group will receive the paracervical block. This intervention will include * Preprocedural pain control: 800 mg Ibuprofen prior to dilator placement * Local anesthetic for tenaculum placement * 18 ml 1% buffered lidocaine Paracervical Block * osmotic dilators placed in the usual fashion * postprocedural assessment
Pain With Paracervical Block or Sham	19 units on a scale Standard Deviation 21	39 units on a scale Standard Deviation 18

SECONDARY outcome

Timeframe: Baseline, just prior to PCB or sham procedure

Measure of distance (mm) from the left ("no pain") on the 100-mm visual analog scale (VAS - reflecting magnitude of pain) of pain recorded at baseline prior to the paracervical block or sham block procedure. 0 mm=No Pain and 100 mm= worst possible pain. A higher score indicates a higher level of pain.

Outcome measures

Outcome measures
Measure	Sham Group n=7 Participants This non-intervention group will receive the sham paracervical block. This intervention will include * Preprocedural pain control: 800 mg Ibuprofen prior to dilator placement * Local anesthetic for tenaculum placement * Sham Paracervical Block done with capped spinal needle * osmotic dilators placed in the usual fashion * postprocedural assessment	Paracervical Block Group n=7 Participants This intervention group will receive the paracervical block. This intervention will include * Preprocedural pain control: 800 mg Ibuprofen prior to dilator placement * Local anesthetic for tenaculum placement * 18 ml 1% buffered lidocaine Paracervical Block * osmotic dilators placed in the usual fashion * postprocedural assessment
Reported Pain at Baseline	4 units on a scale Standard Deviation 4	19 units on a scale Standard Deviation 29

SECONDARY outcome

Timeframe: 15 minutes after dilator placement

Measure of distance (mm) from the left ("no pain") on the 100-mm visual analog scale (VAS - reflecting magnitude of pain) recorded 15 minutes after osmotic dilator placement. mm=No Pain and 100 mm= worst possible pain. A higher mean score indicates a higher level of pain experienced at this time point.

Outcome measures

Outcome measures
Measure	Sham Group n=7 Participants This non-intervention group will receive the sham paracervical block. This intervention will include * Preprocedural pain control: 800 mg Ibuprofen prior to dilator placement * Local anesthetic for tenaculum placement * Sham Paracervical Block done with capped spinal needle * osmotic dilators placed in the usual fashion * postprocedural assessment	Paracervical Block Group n=7 Participants This intervention group will receive the paracervical block. This intervention will include * Preprocedural pain control: 800 mg Ibuprofen prior to dilator placement * Local anesthetic for tenaculum placement * 18 ml 1% buffered lidocaine Paracervical Block * osmotic dilators placed in the usual fashion * postprocedural assessment
Pain With Overall Dilator Placement	42 units on a scale Standard Deviation 30	35 units on a scale Standard Deviation 23

Adverse Events

Sham Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Paracervical Block Group

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

Ob/Gyn Regulatory Specialist, Women's Health Research Unit

Oregon Health & Science University

Phone: 503-494-3666

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place