Trial Outcomes & Findings for Intraoperative Nitrous Oxide and Postoperative Pain for Patients With Current Opioid Treatment (NCT NCT00210158)

Results Overview

Morphine consumption (mg) during PCA (Patient Controlled Analgesia)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

39 participants

Primary outcome timeframe

Between surgery and up to 48 hours

Results posted on

2025-09-09

Participant Flow

Participant milestones

Participant milestones
Measure	Air Arm (Reference) Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of air and oxygen. Air: Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of air and oxygen.	Protox Arm (Experimental) Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide. Protox: Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide.
Overall Study STARTED	19	20
Overall Study COMPLETED	19	18
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Air Arm (Reference) Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of air and oxygen. Air: Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of air and oxygen.	Protox Arm (Experimental) Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide. Protox: Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide.
Overall Study Protocol Violation	0	2

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Air Arm (Reference) n=19 Participants Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of air and oxygen. Air: Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of air and oxygen.	Protox Arm (Experimental) n=18 Participants Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide. Protox: Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide.	Total n=37 Participants Total of all reporting groups
Age, Continuous	61.6 years STANDARD_DEVIATION 2.8 • n=19 Participants	63.6 years STANDARD_DEVIATION 2.7 • n=18 Participants	62.6 years STANDARD_DEVIATION 2.5 • n=37 Participants
Sex: Female, Male Female	12 Participants n=19 Participants	10 Participants n=18 Participants	22 Participants n=37 Participants
Sex: Female, Male Male	7 Participants n=19 Participants	8 Participants n=18 Participants	15 Participants n=37 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment France	19 participants n=19 Participants	18 participants n=18 Participants	37 participants n=37 Participants

PRIMARY outcome

Timeframe: Between surgery and up to 48 hours

Population: Participants with a record of morphine consumption (mg) during PCA (Patient Controlled Analgesia)

Morphine consumption (mg) during PCA (Patient Controlled Analgesia)

Outcome measures

Outcome measures
Measure	Air Arm (Reference) n=18 Participants Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of air and oxygen. Air: Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of air and oxygen.	Protox Arm (Experimental) n=18 Participants Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide. Protox: Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide.
Post-operative Morphine Consumption	54.6 mg Standard Deviation 51.2	44.8 mg Standard Deviation 46.4

SECONDARY outcome

Timeframe: Between surgery and up to 48 hours

Population: Participants with a VAS score record available.

Pain is measured using a visual analog scale (VAS), ranging from 0 (no pain) to 100 (worst pain ever). A participant is considered to have pain if VAS score is \>= 40.

Outcome measures

Outcome measures
Measure	Air Arm (Reference) n=19 Participants Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of air and oxygen. Air: Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of air and oxygen.	Protox Arm (Experimental) n=16 Participants Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide. Protox: Patients undergo long-term morphine treatment and vertebral cementoplasty. During the procedure, patients are ventilated with a mixture of oxygen and nitrous oxide.
Proportion of Participants With Post-operative Pain	2 Participants	1 Participants

Adverse Events

Air Arm (Reference)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Protox Arm (Experimental)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Simone Mathoulin-Pélissier, Director of Clinical Trials Unit

Institut Bergonié, Comprehensive Cancer Center, Bordeaux, FR

Phone: +33 5 56 33 33 33

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place