Trial Outcomes & Findings for Analgesic Efficacy of Inter Pleural Ropivacaine Road in Post Thoracotomy Pain for Oncologic Surgery (NCT NCT00210132)

NCT ID: NCT00210132

Last Updated: 2025-09-08

Results Overview

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 major pain if VAS score is \>= 70.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 90 participants
• Primary outcome timeframe: Between surgery and up to 48 hours
• Results posted on: 2025-09-08

Participant Flow

Participant milestones

Measure	Ropivacaine Arm ropivacaine at 7.5 mg/ml: 4 ml + 4 ml of saline solution to obtain 8 ml of a ropivacaine solution at 3.75 mg/ml injected into the intrapleural catheter every 6 hours. Treatment administration = every 6 hours for 48 hours. Ropivacaine: ropivacaine at 7.5 mg/ml: 4 ml + 4 ml of saline solution to obtain 8 ml of a ropivacaine solution at 3.75 mg/ml injected into the intrapleural catheter every 6 hours. Treatment administration = every 6 hours for 48 hours.	Reference Arm 8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours. Reference: 8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours.
Overall Study STARTED	45	45
Overall Study COMPLETED	44	41
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Measure	Ropivacaine Arm ropivacaine at 7.5 mg/ml: 4 ml + 4 ml of saline solution to obtain 8 ml of a ropivacaine solution at 3.75 mg/ml injected into the intrapleural catheter every 6 hours. Treatment administration = every 6 hours for 48 hours. Ropivacaine: ropivacaine at 7.5 mg/ml: 4 ml + 4 ml of saline solution to obtain 8 ml of a ropivacaine solution at 3.75 mg/ml injected into the intrapleural catheter every 6 hours. Treatment administration = every 6 hours for 48 hours.	Reference Arm 8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours. Reference: 8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours.
Overall Study Protocol Violation	1	4

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Ropivacaine Arm n=44 Participants ropivacaine at 7.5 mg/ml: 4 ml + 4 ml of saline solution to obtain 8 ml of a ropivacaine solution at 3.75 mg/ml injected into the intrapleural catheter every 6 hours. Treatment administration = every 6 hours for 48 hours. Ropivacaine: ropivacaine at 7.5 mg/ml: 4 ml + 4 ml of saline solution to obtain 8 ml of a ropivacaine solution at 3.75 mg/ml injected into the intrapleural catheter every 6 hours. Treatment administration = every 6 hours for 48 hours.	Reference Arm n=41 Participants 8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours. Reference: 8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours.	Total n=85 Participants Total of all reporting groups
Age, Continuous	56.1 years STANDARD_DEVIATION 12.9 • n=44 Participants	51.4 years STANDARD_DEVIATION 13.6 • n=41 Participants	53.9 years STANDARD_DEVIATION 13.4 • n=85 Participants
Sex: Female, Male Female	19 Participants n=44 Participants	11 Participants n=41 Participants	30 Participants n=85 Participants
Sex: Female, Male Male	25 Participants n=44 Participants	30 Participants n=41 Participants	55 Participants n=85 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment France	44 participants n=44 Participants	41 participants n=41 Participants	85 participants n=85 Participants

PRIMARY outcome

Timeframe: Between surgery and up to 48 hours

Population: Participants with a VAS score 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 major pain if VAS score is >= 70.

Outcome measures

Measure	Ropivacaine Arm n=41 Participants ropivacaine at 7.5 mg/ml: 4 ml + 4 ml of saline solution to obtain 8 ml of a ropivacaine solution at 3.75 mg/ml injected into the intrapleural catheter every 6 hours. Treatment administration = every 6 hours for 48 hours. Ropivacaine: ropivacaine at 7.5 mg/ml: 4 ml + 4 ml of saline solution to obtain 8 ml of a ropivacaine solution at 3.75 mg/ml injected into the intrapleural catheter every 6 hours. Treatment administration = every 6 hours for 48 hours.	Reference Arm n=39 Participants 8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours. Reference: 8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours.
Proportion of Patients With Major Post-operative Pain at Mobilization Following Lung Surgery by Posterolateral Thoracotomy	4 Participants	3 Participants

SECONDARY outcome

Timeframe: between surgery and 48 hours

Population: Participants with available data at 48 hours.

Morphine consumption during the 48 hours following surgery. Morphine consumption is defined as the number of morphine boluses (1 bolus = 1mg).

Outcome measures

Measure	Ropivacaine Arm n=31 Participants ropivacaine at 7.5 mg/ml: 4 ml + 4 ml of saline solution to obtain 8 ml of a ropivacaine solution at 3.75 mg/ml injected into the intrapleural catheter every 6 hours. Treatment administration = every 6 hours for 48 hours. Ropivacaine: ropivacaine at 7.5 mg/ml: 4 ml + 4 ml of saline solution to obtain 8 ml of a ropivacaine solution at 3.75 mg/ml injected into the intrapleural catheter every 6 hours. Treatment administration = every 6 hours for 48 hours.	Reference Arm n=32 Participants 8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours. Reference: 8 ml of saline solution will be injected into the intrapleural catheter. Treatment administration = every 6 hours for 48 hours.
Post-operative Morphine Consumption Following Lung Surgery by Posterolateral Thoracotomy	29.9 boluses Standard Deviation 23.5	15.6 boluses Standard Deviation 17.4

Adverse Events

Ropivacaine Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Reference Arm

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: s.mathoulin@bordeaux.unicancer.fr

Results disclosure agreements

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