Clinical trial NCT02354092: Paracervical Block for Pain Control With Osmotic Dilator Placement
Official title: Paracervical Block for Pain Control During Osmotic Dilator Placement: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Abortion Late
Pain
Keywords: cervical dilation
pain
paracervical block
osmotic dilators
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: Planned Parenthood Federation of America
First posted: 2015-02-03
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: It is estimated that 1.21 million abortions were performed in 2008. Of these, approximately 11% occurred in the second trimester and 1.4% occurred after 21 weeks gestation. In the United States, dilation and evacuation (D\&E) is the most common method of terminating a second trimester pregnancy with greater than 98% of second trimester abortions occurring by D\&E.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Pain at Time of Osmotic Dilator Placement
timeFrame: Within 5 minutes of PCB or sham procedure
Secondary outcomes:
measure: Pain With Paracervical Block or Sham
timeFrame: Within 5 minutes after baseline
measure: Reported Pain at Baseline
timeFrame: Baseline, just prior to PCB or sham procedure
measure: Pain With Overall Dilator Placement
timeFrame: 15 minutes after dilator placement
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Planned Parenthood of the Pacific Southwest: First Avenue Family Planning Michelle Wagner Center
state: California
city: San Diego
country: United States
facility: UCSD Medical Offices South: Women's Health Services
state: California
Study officials:
affiliation: UCSD Department of Reproductive Medicine
name: Lisa Bayer, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: UCSD Department of Reproductive Medicine
name: Sheila Mody, MD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Planned Parenthood of the Pacific Southwest
name: Kelly Culwell, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.