Paracervical Versus Intracervical Lidocaine

NCT00816751 | Completed Results DMC

• 1 other identifier: ONG-08-1781
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to estimate the efficacy of intracervical versus paracervical block on pain experienced during first trimester suction curettage without the use of preoperative cervical ripening. Because of the theoretical improved reliability of stromal block, the investigators hypothesize that intracervical block would produce lower pain scores than paracervical block at the time of cervical dilation.

Conditions

Abortion, Induced; Pain

Keywords

Local anesthesia; Paracervical; Intracervical; Abortion; Pain; Local anesthesia for elective first trimester abortion

Outcome Measures

Primary Outcomes (1)

• Pain Score, as Assessed Using a 10 cm Linear Visual Analog Scale (VAS)

  VAS on a scale of 1 to 10 with 1 being lowest pain and 10 highest amount of pain

  at completion of procedure

Secondary Outcomes (1)

• Gestational Age at Time of Procedure

  At the time of the procedure

Study Arms (2)

1

ACTIVE COMPARATOR

Procedure: Paracervical block; Drug: Buffered Lidocaine, vasopressin, sodium bicarbonate

2

EXPERIMENTAL

Procedure: Intracervical; Drug: Buffered Lidocaine, vasopressin, sodium bicarbonate

Interventions

Paracervical block PROCEDURE

The paracervical block was administered using 20 ml of buffered lidocaine and a 5/8 inch, 25-gauge needle. A small amount was injected at the tenaculum site, and the remainder equally distributed around the cervicovaginal junction at 3, 5, 7, and 9 o'clock. The depth was standardized at 5/8 inch by inserting the needle to the hub.

1

Intracervical PROCEDURE

The intracervical block was administered using 20 ml of buffered lidocaine and a 1-1/2 inch, 20 gauge needle in order to overcome the increased resistance to injection caused by the cervical stroma. A small amount was injected at the tenaculum site, and the remainder into the cervical stroma at 12, 3, 6, and 9 o'clock, at a depth of 1-1/2 inch by inserting the needle to the hub.

2

Buffered Lidocaine, vasopressin, sodium bicarbonate DRUG

The buffered lidocaine preparation for both block techniques consisted of 50 mL of 1% lidocaine, 5 units of vasopressin, and 5 mL 8% sodium bicarbonate.

1; 2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women presenting for elective first trimester abortion

You may not qualify if:

• Gestation over 12 weeks by ultrasound
• Weight less than 98 pounds
• Known allergy to lidocaine
• Known nonviable pregnancy

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

Planned Parenthood

San Diego, California, 92101, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Anesthesia, Obstetrical; Vasopressins; Sodium Bicarbonate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins; Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Results Point of Contact

• Title: Jessica M. Kingston, MD
• Organization: UC San Diego Health

jkingston@ucsd.edu

858-249-1204

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 31, 2008
• First Posted: January 5, 2009
• Study Start: December 1, 2007
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: August 13, 2019
• Results First Posted: August 13, 2019

Record last verified: 2019-07

Locations

US (1)