Paracervical Block for Pain Control With Osmotic Dilator Placement
NCT ID: NCT02354092
Last Updated: 2019-06-11
Study Results
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View full resultsBasic Information
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TERMINATED
NA
14 participants
INTERVENTIONAL
2015-04-02
2015-08-25
Brief Summary
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Detailed Description
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Pre-procedure cervical preparation decreases the incidence of complications associated with D\&E. Cervical dilators are often used prior to second trimester D\&Es to aid in softening and dilating the cervix. Typically, dilator placement occurs the day of the D\&E or 1-2 days prior and oftentimes occurs in an outpatient clinic setting without anesthesia readily available. Many women experience moderate to severe discomfort with osmotic dilator insertion. Providers use various methods to minimize this discomfort including paracervical block (PCB), non-steroidal anti-inflammatory medications (NSAIDs), anxiolytics and narcotics. In particular, PCB and NSAIDs are readily available in the clinic setting and can be used for this purpose. There is, however, no data to support their efficacy in ameliorating the pain of dilator insertion.
Paracervical blocks are used commonly to decrease pain in abortion procedures and other gynecological procedures. The PCB is thought to work primarily by blocking pain conduction via Frankenhauser's plexus. As such, their effect may be most important in relieving the pain associated with cervical dilation. In a recent randomized control trial, PCB prior to first trimester surgical abortion was found to significantly reduce pain with cervical dilation and uterine aspiration. Since osmotic dilator placement primarily involves cervical manipulation and dilation, PCB may provide some pain relief over placebo. The research team proposes a randomized controlled trial to evaluate the efficacy of a PCB in decreasing pain associated with osmotic dilator placement. This trial will also provide information about the degree of pain that women experience during osmotic dilator placement; information not previously known.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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
Local anesthetic for tenaculum placement
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
Sham
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
Dilator Placement
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.
Post-procedural assessment
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.
Preprocedural pain control
800 mg Ibuprofen taken before dilator placement
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
Local anesthetic for tenaculum placement
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
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
Dilator Placement
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.
Post-procedural assessment
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.
Preprocedural pain control
800 mg Ibuprofen taken before dilator placement
Interventions
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Local anesthetic for tenaculum placement
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
Sham
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
Paracervical Block
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
Dilator Placement
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.
Post-procedural assessment
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.
Preprocedural pain control
800 mg Ibuprofen taken before dilator placement
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
FEMALE
Yes
Sponsors
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Planned Parenthood Federation of America
OTHER
University of California, San Diego
OTHER
Responsible Party
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Lisa Bayer
Assistant Professor
Principal Investigators
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Lisa Bayer, MD MPH
Role: PRINCIPAL_INVESTIGATOR
UCSD Department of Reproductive Medicine
Sheila Mody, MD MPH
Role: PRINCIPAL_INVESTIGATOR
UCSD Department of Reproductive Medicine
Kelly Culwell, MD MPH
Role: PRINCIPAL_INVESTIGATOR
Planned Parenthood of the Pacific Southwest
Locations
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Planned Parenthood of the Pacific Southwest: First Avenue Family Planning Michelle Wagner Center
San Diego, California, United States
UCSD Medical Offices South: Women's Health Services
San Diego, California, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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141593
Identifier Type: -
Identifier Source: org_study_id
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