Paracervical Block for Pain Control With Osmotic Dilator Placement

NCT02354092 | Terminated Results

• 1 other identifier: 141593
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

Brief Summary

Cervical dilators are frequently used for preparation prior to second trimester surgical abortion. While their use decreases complications associated with surgical abortion, their placement is often uncomfortable for the patient. Currently there are no proven methods for reducing pain during osmotic dilator placement. The use of numbing medication around the cervix (paracervical block) may decrease this placement pain.

Conditions

Abortion Late; Pain

Keywords

cervical dilation; pain; paracervical block; osmotic dilators

Outcome Measures

Primary Outcomes (1)

• Pain at Time of Osmotic Dilator Placement

  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.

  Within 5 minutes of PCB or sham procedure

Secondary Outcomes (3)

• Pain With Paracervical Block or Sham

  Within 5 minutes after baseline

• Reported Pain at Baseline

  Baseline, just prior to PCB or sham procedure

• Pain With Overall Dilator Placement

  15 minutes after dilator placement

Study Arms (2)

Sham Group

SHAM COMPARATOR

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

Procedure: Local anesthetic for tenaculum placement; Procedure: Sham; Procedure: Dilator Placement; Behavioral: Post-procedural assessment; Drug: Preprocedural pain control

Paracervical Block Group

EXPERIMENTAL

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

Procedure: Local anesthetic for tenaculum placement; Procedure: Paracervical Block; Procedure: Dilator Placement; Behavioral: Post-procedural assessment; Drug: Preprocedural pain control

Interventions

Local anesthetic for tenaculum placement PROCEDURE

2 mL of buffered Lidocaine injected superficially at anterior lip of cervix in 12 o'clock position Drug: 1% Lidocaine Hydrochloride, 8.4% Sodium Bicarbonate

Paracervical Block Group; Sham Group

Sham PROCEDURE

Over 60 seconds, without moving the tenaculum, a capped needle gently touches the vaginal sidewall at the level of the external os at 4 and 8 o'clock positions

Sham Group

Paracervical Block PROCEDURE

18 mL of buffered Lidocaine is slowly injected into the vaginal fornices and equally distributed at 4 and 8 o'clock. The injection is continuous from superficial to deep (3cm) to superficial (injecting with insertion and withdrawal) Drug: 1% Lidocaine Hydrochloride, 8.4% Sodium Bicarbonate

Paracervical Block Group

Dilator Placement PROCEDURE

Osmotic dilators will be placed in the usual fashion with a combination of Dilapan-S and laminaria per clinician preference Drugs: Dilapan-S is a hygroscopic cervical dilator made of a patented hydrogel called AQUACRYL. It is a rigid hydrophilic stick that increases in volume by absorbing fluids and comfortably dilating the cervix. Laminaria is an herbal medicine used to induce labor and abortion. The dried stem of Laminaria mechanically dilates the cervical opening by absorbing water and swelling to several times its original diameter.

Paracervical Block Group; Sham Group

Post-procedural assessment BEHAVIORAL

15 minutes after procedure, subjects will complete a questionnaire that collects information about pain, negative symptoms, and assessment of how effective their pain management was.

Paracervical Block Group; Sham Group

Preprocedural pain control DRUG

800 mg Ibuprofen taken before dilator placement

Paracervical Block Group; Sham Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• voluntarily seeking surgical pregnancy termination
• gestational age on day of study 14w0d to 23w6d confirmed by pelvic ultrasound with a viable pregnancy (no fetal demise diagnosed)
• eligible for second trimester D\&E
• having osmotic dilators placed for cervical preparation the day prior to D\&E
• able and willing to give informed consent and agree to terms of the study
• able to speak and read English or Spanish

You may not qualify if:

• took any prescription or illegal drugs 24 hours prior to the appointment
• drank alcohol 12 hours prior to the appointment
• took any over the counter pain medications 12 hours prior to the appointment other than the standard 800mg of Ibuprofen
• contraindications to osmotic dilators
• allergic reaction or hypersensitivity to NSAIDs or lidocaine
• untreated acute cervicitis or pelvic inflammatory disease
• weight \<100 pounds

Sponsors & Collaborators

• University of California, San Diego: lead
• Planned Parenthood Federation of America: collaborator

Study Sites (2)

Planned Parenthood of the Pacific Southwest: First Avenue Family Planning Michelle Wagner Center

San Diego, California, 92101, United States

Location

UCSD Medical Offices South: Women's Health Services

San Diego, California, 92103, United States

Location

Related Publications (9)

• Glantz JC, Shomento S. Comparison of paracervical block techniques during first trimester pregnancy termination. Int J Gynaecol Obstet. 2001 Feb;72(2):171-8. doi: 10.1016/s0020-7292(00)00292-7.

  PMID: 11166751 BACKGROUND

• Jensen MP, Chen C, Brugger AM. Interpretation of visual analog scale ratings and change scores: a reanalysis of two clinical trials of postoperative pain. J Pain. 2003 Sep;4(7):407-14. doi: 10.1016/s1526-5900(03)00716-8.

  PMID: 14622683 BACKGROUND

• Jones RK, Zolna MR, Henshaw SK, Finer LB. Abortion in the United States: incidence and access to services, 2005. Perspect Sex Reprod Health. 2008 Mar;40(1):6-16. doi: 10.1363/4000608.

  PMID: 18318867 BACKGROUND

• Peterson WF, Berry FN, Grace MR, Gulbranson CL. Second-trimester abortion by dilatation and evacuation: an analysis of 11,747 cases. Obstet Gynecol. 1983 Aug;62(2):185-90.

  PMID: 6866362 BACKGROUND

• Cansino C, Edelman A, Burke A, Jamshidi R. Paracervical block with combined ketorolac and lidocaine in first-trimester surgical abortion: a randomized controlled trial. Obstet Gynecol. 2009 Dec;114(6):1220-1226. doi: 10.1097/AOG.0b013e3181c1a55b.

  PMID: 19935022 BACKGROUND

• Rowbotham MC. What is a "clinically meaningful" reduction in pain? Pain. 2001 Nov;94(2):131-132. doi: 10.1016/S0304-3959(01)00371-2. No abstract available.

  PMID: 11690725 BACKGROUND

• Schulz KF, Grimes DA, Cates W Jr. Measures to prevent cervical injury during suction curettage abortion. Lancet. 1983 May 28;1(8335):1182-5. doi: 10.1016/s0140-6736(83)92464-9.

  PMID: 6133988 BACKGROUND

• Strauss LT, Gamble SB, Parker WY, Cook DA, Zane SB, Hamdan S; Centers for Disease Control and Prevention. Abortion surveillance--United States, 2003. MMWR Surveill Summ. 2006 Nov 24;55(11):1-32.

  PMID: 17119534 BACKGROUND

• Todd KH, Funk KG, Funk JP, Bonacci R. Clinical significance of reported changes in pain severity. Ann Emerg Med. 1996 Apr;27(4):485-9. doi: 10.1016/s0196-0644(96)70238-x.

  PMID: 8604867 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Anesthetics, Local; salicylhydroxamic acid; Anesthesia, Obstetrical

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Sensory System Agents; Peripheral Nervous System Agents; Central Nervous System Agents; Therapeutic Uses; Anesthesia; Anesthesia and Analgesia

Results Point of Contact

• Title: Ob/Gyn Regulatory Specialist, Women's Health Research Unit
• Organization: Oregon Health & Science University

whru@ohsu.edu

503-494-3666

Study Officials

• Lisa Bayer, MD MPH

  UCSD Department of Reproductive Medicine

  PRINCIPAL INVESTIGATOR

• Sheila Mody, MD MPH

  UCSD Department of Reproductive Medicine

  PRINCIPAL INVESTIGATOR

• Kelly Culwell, MD MPH

  Planned Parenthood of the Pacific Southwest

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 29, 2015
• First Posted: February 3, 2015
• Study Start: April 2, 2015
• Primary Completion: August 25, 2015
• Study Completion: August 25, 2015
• Last Updated: June 11, 2019
• Results First Posted: June 11, 2019

Record last verified: 2019-05

Locations

US (2)