Trial Outcomes & Findings for Superiority Study for Pain Treatment After Cesarean (NCT NCT01115101)

NCT ID: NCT01115101

Last Updated: 2016-12-12

Results Overview

The primary outcome measure was the change in patients assessment of pain after cesarean (CS) from baseline. For pain assessment a visual analog scale (VAS) was used. Women were asked to quantify pain using an eleven point numerical rating score from 0 to 10, with 0 indicating no pain, and 10 the worst pain. Single value were calculated (averaged).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 239 participants
• Primary outcome timeframe: Pain level was evaluated before therapy (2h after CS), 12h, 24h, 32h, 40h, 48 and 72h after CS.
• Results posted on: 2016-12-12

Participant Flow

Recruitment between July 2009 and November 2009. Of 1112 patients 257 met the inclusion criteria and 239 agreed to participate

Participant milestones

Measure	Oxycodon Patients randomized to the oral analgesia group received 20mg oxycodone at fixed intervals at 2 and 12 hours after cesarean section (CS).	Patient Controlled Device With Pritramid Patients assigned to the Patient-controlled analgesia (PCA) group received a single use i.v. PCA device (2mg piritramide/ml 0.9% saline, Vygon, Medical Products, Aachen, Germany). A patient initiated i.v. bolus injection contained 1mg piritramide with a lock out interval of 5 minutes. The maximum dose was limited to 30mg piritramide equivalent to 40mg oxycodone total dose.
Overall Study STARTED	113	126
Overall Study COMPLETED	113	126
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Superiority Study for Pain Treatment After Cesarean

Baseline characteristics by cohort

Measure	Oxycodon n=113 Participants Patients randomized to the oral analgesia group received 20mg oxycodone at fixed intervals at 2 and 12 hours after CS.	Patient Controlled Device With Pritramid n=126 Participants Patients assigned to the PCA group received a single use i.v. PCA device (2mg piritramide/ml 0.9% saline, Vygon, Medical Products, Aachen, Germany). A patient initiated i.v. bolus injection contained 1mg piritramide with a lock out interval of 5 minutes. The maximum dose was limited to 30mg piritramide equivalent to 40mg oxycodone total dose.	Total n=239 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	113 Participants n=5 Participants	126 Participants n=7 Participants	239 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	28.5 years STANDARD_DEVIATION 5.9 • n=5 Participants	29.8 years STANDARD_DEVIATION 5.1 • n=7 Participants	29.2 years STANDARD_DEVIATION 5.5 • n=5 Participants
Gender Female	113 Participants n=5 Participants	126 Participants n=7 Participants	239 Participants n=5 Participants
Gender Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Germany	113 participants n=5 Participants	126 participants n=7 Participants	239 participants n=5 Participants

PRIMARY outcome

Timeframe: Pain level was evaluated before therapy (2h after CS), 12h, 24h, 32h, 40h, 48 and 72h after CS.

Population: The sample size (intention to treat) was computed to detect a difference in VAS score at 24h of 1.2 (30% reduction) at a power of 80%, a two-sided significance level of 0.05.

The primary outcome measure was the change in patients assessment of pain after cesarean (CS) from baseline.

For pain assessment a visual analog scale (VAS) was used. Women were asked to quantify pain using an eleven point numerical rating score from 0 to 10, with 0 indicating no pain, and 10 the worst pain.

Single value were calculated (averaged).

Outcome measures

Measure	Oxycodon n=113 Participants Patients randomized to the oral analgesia group received 20mg oxycodone at fixed intervals at 2 and 12 hours after CS.	Patient Controlled Device With Pritramid n=126 Participants Patients assigned to the PCA group received a single use i.v. PCA device (2mg piritramide/ml 0.9% saline, Vygon, Medical Products, Aachen, Germany). A patient initiated i.v. bolus injection contained 1mg piritramide with a lock out interval of 5 minutes. The maximum dose was limited to 30mg piritramide equivalent to 40mg oxycodone total dose.
Difference of Pain Scores on the Visual Analog Scale	5.88 VAS score at 24 hours Standard Deviation 2.01	4.85 VAS score at 24 hours Standard Deviation 2.23

SECONDARY outcome

Timeframe: 6 month

Secondary Outcome Measures were to identify subgroups in benefit of either therapy.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 month

Evaluation of side effects

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 month

Evaluation of time to post surgical mobilization

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 month

Evaluation costs between groups

Outcome measures

Outcome data not reported

Adverse Events

Oxycodon

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Patient Controlled Device With Pritramid

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

Dr. Max Dieterich

University of Rostock

Phone: +493814401

Email: max.dieterich@uni-rostock.de

Results disclosure agreements

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