Paracervical Block in First Trimester Surgical Abortions

Pain Clinical Trial

Official title:

Paracervical Block With Ketorolac and Lidocaine in First Trimester Surgical Abortions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00617097
• Other study ID #: NA_00013075
• Secondary ID: SFP1-1
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: December 28, 2007
• Last updated: October 15, 2014
• Start date: January 2008
• Est. completion date: June 2009

Study information

• Verified date: October 2014
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Surgical Abortion

Intervention

Drug:
• lidocaine
paracervical block with lidocaine
• ketorolac and lidocaine
paracervical block with ketorolac and lidocaine

Locations

Country	Name	City	State
United States	Planned Parenthood Columbia-Willamette	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins University	Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Visual Analogue Scale Regarding Satisfaction Level	100-mm Visual Analogue Scale -- minimum: 0 mm (lower satisfaction), maximum: 100 mm (greater satisfaction)	end of study (prior to clinic discharge)	No
Secondary	Reported Symptoms	fever, chills, vomiting, heavy bleeding/clots (collected without regard to the specific event)	end of study (upon discharge from facility after procedure)	Yes
Secondary	Complications		end of study	Yes