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Completed

NCT Number: NCT00617097

Paracervical Block in First Trimester Surgical Abortions

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Planned Parenthood Columbia-Willamette

Portland, Oregon, 97239, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Lidocaine

Drug

paracervical block with lidocaine

ketorolac and lidocaine

Drug

paracervical block with ketorolac and lidocaine

Primary outcomes

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

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

Secondary outcomes

  1. Visual Analogue Scale Regarding Satisfaction Level

    Time frame: end of study (prior to clinic discharge)

    100-mm Visual Analogue Scale -- minimum: 0 mm (lower satisfaction), maximum: 100 mm (greater satisfaction)

  2. Reported Symptoms

    Time frame: end of study (upon discharge from facility after procedure)

    fever, chills, vomiting, heavy bleeding/clots (collected without regard to the specific event)

  3. Complications

    Time frame: end of study

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Oregon Health and Science University

Registry information

Official study title

Paracervical Block With Ketorolac and Lidocaine in First Trimester Surgical Abortions

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Feb 15, 2008
Registry last updated
Sep 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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