Dose-Response of Adenosine for Perioperative Pain

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00298636

Enrollment

160

Registered

2006-03-02

Start date

2005-10-31

Completion date

Unknown

Last updated

2006-08-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Perioperative Pain

Brief 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.

Interventions

DRUGadenosine

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

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;

Design outcomes

Primary

Measure	Time frame
Dose-response	—

Secondary

Measure	Time frame
efficacy	—

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026