Trial Outcomes & Findings for Infiltration Analgesia After Caesarean Section (NCT NCT01094106)

NCT ID: NCT01094106

Last Updated: 2020-08-18

Results Overview

The amount of oxycodone required 48 hours after operation. Oxycodone was administered when the strength of pain is over 3 on numeric rating scale (NRS) 0-10.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 70 participants
• Primary outcome timeframe: 48 hours
• Results posted on: 2020-08-18

Participant Flow

Three patients were excluded after recruitment and randomisation, for the following reasons: For one patient, an emergency operation was needed before the scheduled operation time; for one patient, the hospital pharmacy was unable to provide the study drug in time, and for one patient, no study drug was initiated because of communication errors.

Participant milestones

Measure	Ropivacaine 0,75% Postoperative wound infusion 15 mg /h / 48h Ropivacaine 0,75%: Postoperative wound infusion 2 ml/ h/ 48h	NaCl 0,9% Postoperative wound infusion with NaCl 0,9% 2 ml /h /48h NaCl 0,9%: Postoperative wound infusion 2 ml/h/48h
Overall Study STARTED	33	34
Overall Study COMPLETED	33	34
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Infiltration Analgesia After Caesarean Section

Baseline characteristics by cohort

Measure	Ropivacaine 0,75% n=33 Participants Patients undergoing caesarean section under spinal anaesthesia Ropivacaine 0,75%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/ h/ 48h	NaCl 0,9% n=34 Participants Patients undergoing caesarean section under spinal anaesthesia NaCl 0,9%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/h/48h	Total n=67 Participants Total of all reporting groups
Age, Continuous	30.1 years STANDARD_DEVIATION 5.7 • n=5 Participants	30.9 years STANDARD_DEVIATION 5.7 • n=7 Participants	30.5 years STANDARD_DEVIATION 5.7 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants	34 Participants n=7 Participants	67 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Finland	33 participants n=5 Participants	34 participants n=7 Participants	67 participants n=5 Participants
Weight, kg	75.8 kg STANDARD_DEVIATION 12.6 • n=5 Participants	80.6 kg STANDARD_DEVIATION 17.2 • n=7 Participants	78.2 kg STANDARD_DEVIATION 15.2 • n=5 Participants
Height, cm	162.4 cm STANDARD_DEVIATION 5.7 • n=5 Participants	162.9 cm STANDARD_DEVIATION 6.4 • n=7 Participants	162.6 cm STANDARD_DEVIATION 6.0 • n=5 Participants
Dose of spinal bupivacaine, mg	11.9 mg STANDARD_DEVIATION 0.8 • n=5 Participants	11.7 mg STANDARD_DEVIATION 0.8 • n=7 Participants	11.8 mg STANDARD_DEVIATION 0.8 • n=5 Participants
Length of operation, min	50.6 min STANDARD_DEVIATION 18.3 • n=5 Participants	46.6 min STANDARD_DEVIATION 13.8 • n=7 Participants	47.0 min STANDARD_DEVIATION 16.2 • n=5 Participants

PRIMARY outcome

Timeframe: 48 hours

The amount of oxycodone required 48 hours after operation. Oxycodone was administered when the strength of pain is over 3 on numeric rating scale (NRS) 0-10.

Outcome measures

Measure	Ropivacaine 0,75% n=33 Participants Patients undergoing caesarean section under spinal anaesthesia Ropivacaine 0,75%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/ h/ 48h	NaCl 0,9% n=34 Participants Patients undergoing caesarean section under spinal anaesthesia NaCl 0,9%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/h/48h
The Demand of Rescue Analgesics (Oxycodone)	47.5 mg Standard Deviation 20.9	57.8 mg Standard Deviation 29.4

SECONDARY outcome

Timeframe: 48 hours, divided to five time intervals (0-6 h, 6-12 h, 12-24 h, 24-36 h and 36-48 h)

Intensity of pain was recorded on a numerical rating scale (0-10), where higher scores mean more severe pain, during rest and when moving, for five time intervals (0-6 h, 6-12 h, 12-24 h, 24-36 h and 36-48 h); for each time interval, the highest recorded pain score was taken into account.

Outcome measures

Measure	Ropivacaine 0,75% n=33 Participants Patients undergoing caesarean section under spinal anaesthesia Ropivacaine 0,75%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/ h/ 48h	NaCl 0,9% n=34 Participants Patients undergoing caesarean section under spinal anaesthesia NaCl 0,9%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/h/48h
Strength of Pain on Numerical Rating Scale (NRS) Highest recorded pain scores when moving, 0-6 h	6.5 units on a scale Interval 5.0 to 8.0	7 units on a scale Interval 5.0 to 8.0
Strength of Pain on Numerical Rating Scale (NRS) Highest recorded pain scores when moving, 6-12 h	5 units on a scale Interval 4.0 to 7.0	6 units on a scale Interval 4.0 to 7.0
Strength of Pain on Numerical Rating Scale (NRS) Highest recorded pain scores at rest, 0-6 h	5 units on a scale Interval 3.0 to 6.0	6 units on a scale Interval 4.0 to 7.0
Strength of Pain on Numerical Rating Scale (NRS) Highest recorded pain scores at rest, 6-12 h	3 units on a scale Interval 2.0 to 5.0	3.75 units on a scale Interval 2.0 to 5.0
Strength of Pain on Numerical Rating Scale (NRS) Highest recorded pain scores at rest, 12-24 h	3 units on a scale Interval 2.0 to 4.0	3 units on a scale Interval 1.5 to 5.0
Strength of Pain on Numerical Rating Scale (NRS) Highest recorded pain scores at rest, 24-36 h	2.25 units on a scale Interval 1.0 to 5.0	3 units on a scale Interval 2.0 to 4.0
Strength of Pain on Numerical Rating Scale (NRS) Highest recorded pain scores at rest, 36-48 h	1 units on a scale Interval 0.0 to 2.0	2 units on a scale Interval 0.0 to 4.0
Strength of Pain on Numerical Rating Scale (NRS) Highest recorded pain scores when moving, 12-24 h	5 units on a scale Interval 4.0 to 7.0	5.75 units on a scale Interval 4.0 to 6.5
Strength of Pain on Numerical Rating Scale (NRS) Highest recorded pain scores when moving, 24-36 h	4.25 units on a scale Interval 3.0 to 6.0	5 units on a scale Interval 3.0 to 6.0
Strength of Pain on Numerical Rating Scale (NRS) Highest recorded pain scores when moving, 36-48 h	3 units on a scale Interval 2.0 to 4.5	4 units on a scale Interval 3.0 to 6.0

SECONDARY outcome

Timeframe: 48 hours

The numbers of patients with at least mild nausea at any time post-operatively.

Outcome measures

Measure	Ropivacaine 0,75% n=33 Participants Patients undergoing caesarean section under spinal anaesthesia Ropivacaine 0,75%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/ h/ 48h	NaCl 0,9% n=34 Participants Patients undergoing caesarean section under spinal anaesthesia NaCl 0,9%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/h/48h
Postoperative Nausea and Vomiting (PONV)	7 participants	11 participants

Adverse Events

Ropivacaine 0,75%

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

NaCl 0,9%

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ropivacaine 0,75% n=33 participants at risk Patients undergoing caesarean section under spinal anaesthesia Ropivacaine 0,75%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/ h/ 48h	NaCl 0,9% n=34 participants at risk Patients undergoing caesarean section under spinal anaesthesia NaCl 0,9%: Postoperative wound infusion; initial bolus of 10 ml, followed by an infusion of 2 ml/h/48h
Skin and subcutaneous tissue disorders Wound dressings becoming unpleasantly wet, resulting in termination of the study drug infusion	3.0% 1/33	2.9% 1/34
Skin and subcutaneous tissue disorders Smarting of the wound	0.00% 0/33	2.9% 1/34

Additional Information

Matti Reinikainen

Kuopio University Hospital

Phone: +358447176681

Email: matti.reinikainen@kuh.fi

Results disclosure agreements

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