Dose-Response of Adenosine for Perioperative Pain

Perioperative Pain Clinical Trial

Official title:

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Escalating Dose-Response Trial of Intravenous Adenosine for Perioperative Analgesia in Females Undergoing Abdominal Hysterectomy or Myomectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00298636
• Other study ID #: ADO-122
• Status: Completed
• Phase: Phase 2
• First received: February 28, 2006
• Last updated: August 1, 2006
• Start date: October 2005

Study information

• Verified date: August 2006
• Source: Xsira Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Adenosine A1 and A2 receptors are widely distributed in the brain and spinal cord and represent a non-opiate target for pain management. Activated spinal A1 receptors inhibit sensory transmission by inhibiting the slow ventral root potential, which is the C-fiber-evoked excitatory response associated with nociception. Adenosine may inhibit intrinsic neurons through an increase in K+ conductance and presynaptic inhibition of sensory nerve terminals to inhibit the release of substance P and perhaps glutamate. Although adenosine A3 receptors are not found in the nervous system, adenosine is also known to have anti-inflammatory properties that may contribute to pain relief in the peripheral setting of inflammation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Female gender; age 18 to 65 years;

• American Society of Anesthesiology (ASA) physical classification I to III;

• scheduled for non-emergent abdominal hysterectomy (with or without salpingo-oophorectomy) or myomectomy under general anesthesia;

Exclusion Criteria:

• ASA physical classification of IV or V;

• documented history of cardiovascular disease including coronary artery disease, uncontrolled hypertension, aortic stenosis, congestive heart failure, cardiac arrhythmias or conduction defects greater that first degree atrioventricular (AV) block, sinoatrial (SA) or AV node disease including sick sinus syndrome or symptomatic bradycardia, presence of devices including pacemakers or internal defibrillators, or history of symptoms consistent with any of the aforementioned conditions (e.g., angina, dyspnea on exertion, paroxysmal nocturnal dyspnea);

• history of asthma, bronchospastic lung disease, or hyper-reactive airway disease;

• history of gout;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Perioperative Pain

Intervention

Drug:
• adenosine

Locations

Country	Name	City	State
United States	Medical College of Georgia	Augusta	Georgia
United States	University of Chicago	Chicago	Illinois
United States	Duke University Medical Center	Durham	North Carolina
United States	Memorial Hermann-Memorial City Hospital	Houston	Texas
United States	University of Miami/Miller School of Medicine	Miami	Florida
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	University of California, San Francisco	San Francisco	California
United States	Wake Forest University/Forsyth Medical Center	Winston Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Xsira Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose-response
Secondary	efficacy