Paracervical Block in First Trimester Surgical Abortions

NCT ID: NCT00617097

Last Updated: 2017-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-06-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

paracervical block with lidocaine

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

Group Type: ACTIVE_COMPARATOR

lidocaine

Intervention Type: DRUG

paracervical block with lidocaine

paracervical block with ketorolac and lidocaine

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

Group Type: EXPERIMENTAL

ketorolac and lidocaine

Intervention Type: DRUG

paracervical block with ketorolac and lidocaine

Interventions

lidocaine

paracervical block with lidocaine

Intervention Type: DRUG

ketorolac and lidocaine

paracervical block with ketorolac and lidocaine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Oregon Health and Science University

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johns Hopkins University, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Planned Parenthood Columbia-Willamette

Portland, Oregon, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 19935022 (View on PubMed)

Other Identifiers

SFP1-1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

NA_00013075

Identifier Type: -

Identifier Source: org_study_id