Trial Outcomes & Findings for Preemptive Local Anesthesia in Vaginal Surgery (NCT NCT00318292)

NCT ID: NCT00318292

Last Updated: 2010-11-18

Results Overview

Visual Analogue Scale (VAS) pain score on a scale from 0 (None) to 10 (Worst) points.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 90 participants
• Primary outcome timeframe: 30 minutes post-op
• Results posted on: 2010-11-18

Participant Flow

Patients undergoing vaginal hysterectomy with McCall culdoplasty at the Mayo Clinic Hospital were recruited from 17 May 2006 to 14 February 2008. We screened 146 patients who were scheduled for vaginal surgery, and 142 were eligible to participate.

95 of the eligible patients consented to participate. 3 were excluded prior to treatment because they converted to abdominal hysterectomy. 2 were excluded because the study treatment was unintentionally missed by the operating staff.

Participant milestones

Measure	Preemptive Local Analgesia (PLA) Active preemptive local analgesia.	Placebo Placebo for preemptive local analgesia.
Overall Study STARTED	45	45
Overall Study COMPLETED	45	45
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Preemptive Local Anesthesia in Vaginal Surgery

Baseline characteristics by cohort

Measure	Preemptive Local Analgesia (PLA) n=45 Participants Active preemptive local analgesia.	Placebo n=45 Participants Placebo for preemptive local analgesia.	Total n=90 Participants Total of all reporting groups
Age Continuous	57 years STANDARD_DEVIATION 15 • n=93 Participants	54 years STANDARD_DEVIATION 20 • n=4 Participants	56 years STANDARD_DEVIATION 18 • n=27 Participants
Sex: Female, Male Female	45 Participants n=93 Participants	45 Participants n=4 Participants	90 Participants n=27 Participants
Sex: Female, Male Male	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
BMI	26.2 kg/m^2 STANDARD_DEVIATION 5.4 • n=93 Participants	25.4 kg/m^2 STANDARD_DEVIATION 4.0 • n=4 Participants	25.8 kg/m^2 STANDARD_DEVIATION 4.8 • n=27 Participants

PRIMARY outcome

Timeframe: 30 minutes post-op

Visual Analogue Scale (VAS) pain score on a scale from 0 (None) to 10 (Worst) points.

Outcome measures

Measure	Preemptive Local Analgesia (PLA) n=45 Participants Active preemptive local analgesia.	Placebo n=45 Participants Placebo for preemptive local analgesia.
Visual Analogue Scale (VAS) Pain Score	2.5 points on a scale Standard Deviation 3.1	4.4 points on a scale Standard Deviation 3.0

Adverse Events

Preemptive Local Analgesia (PLA)

Serious events: 5 serious events

Other events: 18 other events

Deaths: 0 deaths

Placebo

Serious events: 3 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Measure	Preemptive Local Analgesia (PLA) n=45 participants at risk Active preemptive local analgesia.	Placebo n=45 participants at risk Placebo for preemptive local analgesia.
Cardiac disorders Atrial Fibrillation	2.2% 1/45 • 6 weeks.	0.00% 0/45 • 6 weeks.
Infections and infestations Bacterial Infection	0.00% 0/45 • 6 weeks.	2.2% 1/45 • 6 weeks.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.2% 1/45 • 6 weeks.	0.00% 0/45 • 6 weeks.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/45 • 6 weeks.	2.2% 1/45 • 6 weeks.
Gastrointestinal disorders Postoperative Nausea and Vomiting Requiring Readmission	0.00% 0/45 • 6 weeks.	2.2% 1/45 • 6 weeks.
Surgical and medical procedures Postoperative Pain Requiring Readmission	4.4% 2/45 • 6 weeks.	0.00% 0/45 • 6 weeks.
Vascular disorders Pulmonary Embolism	2.2% 1/45 • 6 weeks.	0.00% 0/45 • 6 weeks.

Other adverse events

Measure	Preemptive Local Analgesia (PLA) n=45 participants at risk Active preemptive local analgesia.	Placebo n=45 participants at risk Placebo for preemptive local analgesia.
Respiratory, thoracic and mediastinal disorders Pneumonia	4.4% 2/45 • 6 weeks.	0.00% 0/45 • 6 weeks.
Surgical and medical procedures Rectal Pain	2.2% 1/45 • 6 weeks.	0.00% 0/45 • 6 weeks.
Renal and urinary disorders Urinary Retention	35.6% 16/45 • 6 weeks.	48.9% 22/45 • 6 weeks.

Additional Information

Michaele Menghini

Mayo Clinic

Phone: 480-301-6651

Email: menghini.michaele@mayo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place