Intraoperative Nitrous Oxide and Postoperative Pain for Patients With Current Opioid Treatment (PROTOX)

Institut Bergonié

Status and phase: Completed; Phase 2

Conditions: Chronic Pain

Treatments: Procedure: Air; Procedure: Protox

Study type: Interventional

Funder types: Other

Identifiers

NCT00210158

IB2005-05

Details and patient eligibility

About

Peroperative opioids are known to induce N-Methyl-D-Aspartate dependent enhancement of postoperative hyperalgesia. For patients with current opioid treatment, these phenomena could be exagerated and could produce greater postoperative opioid consumption and higher pain score. Since Nitrous oxide has anti- N-Methyl-D-Aspartate properties, the aim of this study was to evaluate, in patients with current opioid treatment, the effects of peroperative Nitous oxide on postoperative opioid consumption and pain score, after vertebroplasty.

Enrollment: 39 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Older than 18 years
• Current opioid treatment > 1 month
• patients scheduled to undergo vertebroplasty with general anesthesia

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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39 participants in 2 patient groups

Air arm (Reference)

Sham Comparator group

Description:

Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of air and oxygen.

Treatment:

Procedure: Air

Protox Arm (Experimental)

Experimental group

Description:

Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide.

Treatment:

Procedure: Protox