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Refining Paracervical Block Techniques for Pain Control in First Trimester Surgical Abortion

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01466491
First Posted: November 8, 2011
Last Update Posted: July 25, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Planned Parenthood Federation of America
Information provided by (Responsible Party):
Paula Bednarek, Oregon Health and Science University
Results First Submitted: June 26, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Pain
Intervention: Drug: Paracervical block technique with lidocaine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
4-site Injection

The superior technique of Phase 1 will be compared to a 4-site technique (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).

Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.

2-site Injection

The superior technique of Phase 1 will be compared to a 2-site technique (2 mL injected at the tenaculum site, 18 mL equally distributed between 4 and 8 o’clock) in a randomized fashion (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).

Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.

4-Site PCB Followed by 3-minute Wait

Women will be randomized to receive a 4-site PCB followed by a 3-minute wait (PCB 20/4/3) prior to dilation

Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.

4-site PCB Followed by no Wait

Women will be randomized to receive a 4-site PCB followed by no wait (PCB 20/4/0).

Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.


Participant Flow:   Overall Study
    4-site Injection   2-site Injection   4-Site PCB Followed by 3-minute Wait   4-site PCB Followed by no Wait
STARTED   83   83   83   83 
COMPLETED   83   80   80   83 
NOT COMPLETED   0   3   3   0 
Protocol Violation                0                3                2                0 
Missing Data                0                0                1                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
4-site Injection

The superior technique of Phase 1 will be compared to a 4-site technique (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).

Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.

2-site Injection

The superior technique of Phase 1 will be compared to a 2-site technique (2 mL injected at the tenaculum site, 18 mL equally distributed between 4 and 8 o’clock) in a randomized fashion (both techniques will have no wait prior to dilation unless wait was superior in Phase 1).

Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.

4-Site PCB Followed by 3-minute Wait

Women will be randomized to receive a 4-site PCB followed by a 3-minute wait (PCB 20/4/3) prior to dilation

Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.

4-site PCB Followed by no Wait

Women will be randomized to receive a 4-site PCB followed by no wait (PCB 20/4/0).

Paracervical block technique with lidocaine: The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.

Total Total of all reporting groups

Baseline Measures
   4-site Injection   2-site Injection   4-Site PCB Followed by 3-minute Wait   4-site PCB Followed by no Wait   Total 
Overall Participants Analyzed 
[Units: Participants]
 83   80   80   83   326 
Age 
[Units: Participants]
Count of Participants
         
<=18 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      83 100.0%      80 100.0%      80 100.0%      83 100.0%      326 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 25.2  (5.2)   25.5  (5.3)   25.2  (5.2)   26.4  (5.5)   25.575  (5.3) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
         
Female      83 100.0%      80 100.0%      80 100.0%      83 100.0%      326 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
         
United States   83   80   80   83   326 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Patient Perception of Pain   [ Time Frame: At time of uterine aspiration (baseline) ]

2.  Secondary:   Pain Scores Throughout Procedure at Various Time Points   [ Time Frame: up to several hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Paula Bednarek
Organization: Oregon Health & Science University
phone: 503-494-3666
e-mail: whru@ohsu.edu



Responsible Party: Paula Bednarek, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01466491     History of Changes
Other Study ID Numbers: OHSU SFP 7688
First Submitted: November 1, 2011
First Posted: November 8, 2011
Results First Submitted: June 26, 2017
Results First Posted: July 25, 2017
Last Update Posted: July 25, 2017