Preemptive Local Anesthesia in Vaginal Surgery

Pain, Postoperative Clinical Trial

Official title:

Preemptive Local Anesthesia in Vaginal Surgery, A Prospective, Randomised Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00318292
• Other study ID #: 63-06
• Status: Completed
• Phase: Phase 4
• First received: April 24, 2006
• Last updated: October 22, 2010
• Start date: April 2006
• Est. completion date: March 2008

Study information

• Verified date: October 2010
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Preemptive analgesia is an intervention which provides an anesthetic prior to initiating a painful stimulus. This trial is examining the effects of a local anesthetic given at the point of innervation prior to performing a vaginal hysterectomy with suspension sutures.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women undergoing vaginal hysterectomy with McCall's culdoplasty

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, Postoperative

Intervention

Drug:
• bupivacaine and epinephrine
20 ml of 0.5% bupivacaine with 1:200,000 epinephrine paracervical injection.
• Placebo
20 ml normal saline injection.

Locations

Country	Name	City	State
United States	Mayo Clinic	Scottsdale	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

Long JB, Eiland RJ, Hentz JG, Mergens PA, Magtibay PM, Kho RM, Magrina JF, Cornella JL. Randomized trial of preemptive local analgesia in vaginal surgery. Int Urogynecol J Pelvic Floor Dysfunct. 2009 Jan;20(1):5-10. doi: 10.1007/s00192-008-0716-6. Epub 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale (VAS) Pain Score	Visual Analogue Scale (VAS) pain score on a scale from 0 (None) to 10 (Worst) points.	30 minutes post-op	No