Paracervical Block in First Trimester Surgical Abortions

NCT00617097 | Completed Phase 2 Results

• 2 other identifiers: NA_00013075SFP1-1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators primary objective is to study the analgesic effects of combined ketorolac and lidocaine in a paracervical block compared to preoperative ibuprofen followed by intra-operative paracervical block with lidocaine alone on women undergoing first trimester surgical abortions. The investigators hypothesize that women who receive a paracervical block of combined ketorolac and lidocaine will experience less pain during the procedure based on a visual analog scale (VAS) compared to those who receive preoperative ibuprofen and a paracervical block with lidocaine alone. This randomized, multi-site, placebo-controlled clinical trial will investigate the difference in perceived pain from first trimester surgical abortions using a paracervical block of combined ketorolac and lidocaine compared to preoperative ibuprofen and paracervical block with lidocaine alone. A total of fifty women who are seeking elective surgical abortions of intrauterine pregnancies less than 11 0/7 weeks' gestation will be recruited from Johns Hopkins Bayview Medical Center, Planned Parenthood of Maryland in Baltimore, Maryland and Planned Parenthood Columbia-Willamette in Portland, Oregon. Pain before, during, and after surgical abortion will be measured using a 100-mm VAS. The primary outcome of interest is the mean difference in pain level from preoperative baseline to time after cervical dilation comparing the treatment groups. If the investigators see greater pain reduction associated with the paracervical block of lidocaine and ketorolac, adoption of this regimen may improve pain management during first trimester surgical abortions. If combined ketorolac and lidocaine when administered as a paracervical block is proven to be efficacious, the need for additional analgesia in first trimester surgical abortions can be minimized.

Conditions

Pain; Surgical Abortion

Keywords

Pain associated with first trimester surgical abortion

Outcome Measures

Primary Outcomes (1)

• Level of Pain During Specific Time Intervals Throughout D&C Procedure.

  100-mm Visual Analogue Scale (VAS) during specific time intervals of D\&C procedure: minimum: 0 mm (less pain); maximum: 100 mm (more pain) Time intervals include: basline expected level of pain during procedure, after speculum insertion, at paracervical block injection, after dilation, end of procedure, and 30 minutes after procedure.

  Baseline, Speculum Insertion, at Paracervical block injection, After dilation, End of procedure, 30 minutes after procedure

Secondary Outcomes (3)

• Visual Analogue Scale Regarding Satisfaction Level

  end of study (prior to clinic discharge)

• Reported Symptoms

  end of study (upon discharge from facility after procedure)

• Complications

  end of study

Study Arms (2)

paracervical block with lidocaine

ACTIVE COMPARATOR

Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion

Drug: lidocaine

paracervical block with ketorolac and lidocaine

EXPERIMENTAL

Subjects who receive pain control using paracervical block with ketorolac and lidocaine during first trimester surgical abortion

Drug: ketorolac and lidocaine

Interventions

lidocaine DRUG

paracervical block with lidocaine

paracervical block with lidocaine

ketorolac and lidocaine DRUG

paracervical block with ketorolac and lidocaine

paracervical block with ketorolac and lidocaine

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age greater than or equal to 18 years
• English-speaking
• ability and willingness to sign the informed consent
• ability and willingness to comply with the terms of the study
• voluntary request for pregnancy termination
• ultrasound-confirmed singleton intrauterine pregnancy with an estimated gestational age not exceeding 76 days (10 6/7 weeks) from the first day of the preceding menstrual cycle

You may not qualify if:

• women who require or request sedation
• untreated acute cervicitis or pelvic inflammatory disease
• contraindications to lidocaine such as allergy to lidocaine, cardiac arrhythmia or heart block, and porphyria
• allergic reaction or sensitivity to lorazepam or NSAIDs
• chronic NSAID use
• history of gastritis or gastric ulcer
• acute renal failure or chronic renal disease
• chronic liver disease
• history of bleeding diathesis
• chronic narcotic use
• current or past history of illegal drug use (excluding marijuana)

Sponsors & Collaborators

• Johns Hopkins University: lead
• Oregon Health and Science University: collaborator

Study Sites (1)

Planned Parenthood Columbia-Willamette

Portland, Oregon, 97239, United States

Location

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Lidocaine; Ketorolac

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Catherine Cansino
• Organization: University of California, Davis

Catherine.Cansino@ucdmc.ucdavis.edu

9167346930

Study Officials

• Johns Hopkins University, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2007
• First Posted: February 15, 2008
• Study Start: January 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: June 1, 2009
• Last Updated: September 15, 2017
• Results First Posted: September 15, 2014

Record last verified: 2017-08

Locations

US (1)