Trial Outcomes & Findings for Wound Infusion vs Spinal Morphine for Post-caesarean Analgesia (NCT NCT02264821)

Results Overview

T0 until first request of morphine PCAIV

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

192 participants

Primary outcome timeframe

30 hours after spinal injection T0

Results posted on

2015-06-09

Participant Flow

Participant milestones

Participant milestones
Measure	Ropivacaine Infiltration ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline ropivacaine infiltration: wound infiltration	Rachi Morphine 100 µg intrathecal morphine and saline infiltration intrathecal morphine: 100 µg added to the spinal anaesthesia	Placebo intrathecal saline and saline infiltration placebo: placebo in spinal anaesthesia and in wound infiltration
Overall Study STARTED	64	64	64
Overall Study COMPLETED	63	61	58
Overall Study NOT COMPLETED	1	3	6

Reasons for withdrawal

Reasons for withdrawal
Measure	Ropivacaine Infiltration ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline ropivacaine infiltration: wound infiltration	Rachi Morphine 100 µg intrathecal morphine and saline infiltration intrathecal morphine: 100 µg added to the spinal anaesthesia	Placebo intrathecal saline and saline infiltration placebo: placebo in spinal anaesthesia and in wound infiltration
Overall Study Protocol Violation	1	3	6

Baseline Characteristics

Wound Infusion vs Spinal Morphine for Post-caesarean Analgesia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ropivacaine Infiltration n=63 Participants ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline ropivacaine infiltration: wound infiltration	Rachi Morphine n=61 Participants 100 µg intrathecal morphine and saline infiltration intrathecal morphine: 100 µg added to the spinal anaesthesia	Placebo n=58 Participants intrathecal saline and saline infiltration placebo: placebo in spinal anaesthesia and in wound infiltration	Total n=182 Participants Total of all reporting groups
Age, Continuous	30 years n=99 Participants	32 years n=107 Participants	32 years n=206 Participants	32 years n=7 Participants
Sex: Female, Male Female	63 Participants n=99 Participants	61 Participants n=107 Participants	58 Participants n=206 Participants	182 Participants n=7 Participants
Sex: Female, Male Male	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants
Region of Enrollment Belgium	63 participants n=99 Participants	61 participants n=107 Participants	58 participants n=206 Participants	182 participants n=7 Participants

PRIMARY outcome

Timeframe: 30 hours after spinal injection T0

T0 until first request of morphine PCAIV

Outcome measures

Outcome measures
Measure	Ropivacaine Infiltration n=63 Participants ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline ropivacaine infiltration: wound infiltration	Rachi Morphine n=61 Participants 100 µg intrathecal morphine and saline infiltration intrathecal morphine: 100 µg added to the spinal anaesthesia	Placebo n=58 Participants intrathecal saline and saline infiltration placebo: placebo in spinal anaesthesia and in wound infiltration
Duration of Effective Analgesia	351 minutes Interval 227.0 to 594.0	380 minutes Interval 215.0 to 1527.0	247 minutes Interval 182.0 to 338.0

PRIMARY outcome

Timeframe: 30 hours after spinal injection T0

Morphine consumption with PCAIV

Outcome measures

Outcome measures
Measure	Ropivacaine Infiltration n=63 Participants ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline ropivacaine infiltration: wound infiltration	Rachi Morphine n=61 Participants 100 µg intrathecal morphine and saline infiltration intrathecal morphine: 100 µg added to the spinal anaesthesia	Placebo n=58 Participants intrathecal saline and saline infiltration placebo: placebo in spinal anaesthesia and in wound infiltration
Morphine Consumption	8 milligrammes Interval 4.0 to 20.0	4 milligrammes Interval 1.0 to 10.0	20.5 milligrammes Interval 9.5 to 31.0

SECONDARY outcome

Timeframe: 30 hours after spinal injection

Is there a decrease of the incidence of morphine side effects such as nausea, vomiting, pruritus?

Outcome measures

Outcome data not reported

Adverse Events

Ropivacaine Infiltration

Serious events: 0 serious events

Other events: 61 other events

Deaths: 0 deaths

Rachi Morphine

Serious events: 0 serious events

Other events: 61 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 58 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Ropivacaine Infiltration n=63 participants at risk ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline ropivacaine infiltration: wound infiltration	Rachi Morphine n=61 participants at risk 100 µg intrathecal morphine and saline infiltration intrathecal morphine: 100 µg added to the spinal anaesthesia	Placebo n=58 participants at risk intrathecal saline and saline infiltration placebo: placebo in spinal anaesthesia and in wound infiltration
Vascular disorders Hypotension	34.9% 22/63	37.7% 23/61	51.7% 30/58
Gastrointestinal disorders Nausea and/or vomiting	15.9% 10/63	29.5% 18/61	15.5% 9/58
Skin and subcutaneous tissue disorders Pruritus	49.2% 31/63	57.4% 35/61	36.2% 21/58

Additional Information

Dr Madeleine Wilwerth

CHU Brugmann

Phone: 003224773996

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place