PainPhase 4NCT01115101

Superiority Study for Pain Treatment After Cesarean

A Phase 4 study testing Oral Oxycodon and Piritramid in people with Pain, run by Max Dieterich at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to investigate adequate pain treatment for patients after cesarean. In this study oral opioids were compared to intravenous opioids as they are supposed to provide superior pain control. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Pain
What is being tested?: Oral Oxycodon and Piritramid
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 239 participants
Where: 1 siteGermany
Study dates: Jul 2009to Nov 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

cesarean in spinal anesthesia,
no history of opioid or metamizol treatment
written consent
ability to use a Patient-controlled analgesia device

Who cannot join

cesarean in general anaesthesia
use of peridural catheter for pre-, peri- or post cesarean analgesia
additional post cesarean metamizol use
allergy/hypersensitivity to morphine, oxycodon, acetaminophen or ibuprofen
chronic use of general anaesthesia
history of known pain syndrome

Trial locations and contacts

1 site in 1 country.

Germany1 site

University of Rostock, Department of Obstetrics and Gynecology
Rostock, Mecklenburg-Vorpommern, 18055

Other trials in Germany

About this study

Official title: A Randomized Controlled Trial: Pain Management After Cesarean Section: Oxycodon vs. Intravenous Piritramide

Read the detailed description

Pain management after cesarean is an important topic for women. Pain during and after surgery is their greatest concern.

After surgery quick mobilization is important to take care of the newborn. When using a patient controlled analgesia (PCA) device mobilization is limited and women can not meet their expectations to take care of the newborn. Oral analgesia in comparison offers superior patient satisfaction.

This trial was conducted to investigate the effectiveness of both treatment options and improve patients pain management and overall content after cesarean.

Conditions: Pain
Being tested: Oral Oxycodon, Piritramid
Keywords: pain after cesarean, visual analog scale, oxycodon, piritramid
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Oral OxycodonDrug
Patients assigned to the oral analgesia group received 20mg oxycodon at fixed intervals: 2 hours (h) and between 12h and 14h after cesarean.
PiritramidDrug
Patients assigned to the PCA group received a single use intravenous PCA device (Vygon, Medical Products, Aachen, Germany) with a 30ml deposit of 9% sodium chloride solution containing 60mg piritramide. Bolus injection of 0.5ml was administered by the patient herself if needed, with a lock out interval of 5 minutes
Patients assigned to the oral analgesia group received 20mg oxycodon at fixed intervals: 2 hours (h) and between 12h and 14h after cesarean. The PCA was discontinued after 24 hours or earlier if demanded.

Study groups in NCT01115101
Study group	Role	What they receive
Oxycodon	Experimental	Not described Receives: Drug: Oral Oxycodon
Patient controlled analgesia (PCA) device with Pritramid	Active comparator	Not described Receives: Drug: Piritramid

What is being measured

The primary outcome is the main question the study is designed to answer.

Difference of Pain Scores on the Visual Analog Scale
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).
Measured: Pain level was evaluated before therapy (2h after CS), 12h, 24h, 32h, 40h, 48 and 72h after CS.

Secondary outcomes (4)

Subgroups
Secondary Outcome Measures were to identify subgroups in benefit of either therapy.
Measured: 6 month
Side Effects
Evaluation of side effects
Measured: 6 month
Mobilisation
Evaluation of time to post surgical mobilization
Measured: 6 month
Costs
Evaluation costs between groups
Measured: 6 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2009Nov 2009

First posted4 May 2010 (estimated)
Study startJul 2009
Primary completionNov 2009
Study completionNov 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 239 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01115101
Sponsor's protocol ID: KJ-2009-MD
Status last verified: Oct 2016
First submitted: 27 Apr 2010
Last updated: 12 Dec 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Stamer UM, Wiese R, Stuber F, Wulf H, Meuser T. Change in anaesthetic practice for Caesarean section in Germany. Acta Anaesthesiol Scand. 2005 Feb;49(2):170-6. doi: 10.1111/j.1399-6576.2004.00583.x.
PubMed 15715617
Davis KM, Esposito MA, Meyer BA. Oral analgesia compared with intravenous patient-controlled analgesia for pain after cesarean delivery: a randomized controlled trial. Am J Obstet Gynecol. 2006 Apr;194(4):967-71. doi: 10.1016/j.ajog.2006.02.025.
PubMed 16580284
Gammaitoni AR, Galer BS, Bulloch S, Lacouture P, Caruso F, Ma T, Schlagheck T. Randomized, double-blind, placebo-controlled comparison of the analgesic efficacy of oxycodone 10 mg/acetaminophen 325 mg versus controlled-release oxycodone 20 mg in postsurgical pain. J Clin Pharmacol. 2003 Mar;43(3):296-304. doi: 10.1177/0091270003251147.
PubMed 12638399
Carvalho B, Cohen SE, Lipman SS, Fuller A, Mathusamy AD, Macario A. Patient preferences for anesthesia outcomes associated with cesarean delivery. Anesth Analg. 2005 Oct;101(4):1182-1187. doi: 10.1213/01.ane.0000167774.36833.99.
PubMed 16192541
Dieterich M, Muller-Jordan K, Stubert J, Kundt G, Wagner K, Gerber B. Pain management after cesarean: a randomized controlled trial of oxycodone versus intravenous piritramide. Arch Gynecol Obstet. 2012 Oct;286(4):859-65. doi: 10.1007/s00404-012-2384-5. Epub 2012 May 24.
PubMed 22622852

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Controlled Trial: Pain Management After Cesarean Section: Oxycodon vs. Intravenous Piritramide
ClinicalTrials.gov ID: NCT01115101
Acronym / sponsor ID: KJ-2009-MD
Conditions: Pain
Keywords: pain after cesarean, visual analog scale, oxycodon, piritramid
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 239 participants (actual)
Lead sponsor: Max DieterichUniversity, hospital or other
Collaborators: University of Rostock
Study start: Jul 2009
Primary completion: Nov 2009 (actual)
Study completion: Nov 2009 (actual)
First posted: 4 May 2010 (estimated)
Results: Posted 15 Feb 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Pain management after cesarean is an important topic for women. Pain during and after surgery is their greatest concern.

This trial was conducted to investigate the effectiveness of both treatment options and improve patients pain management and overall content after cesarean.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Oxycodon	Experimental	Drug: Oral Oxycodon
Patient controlled analgesia (PCA) device with Pritramid	Active comparator	Drug: Piritramid

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

cesarean in spinal anesthesia,
no history of opioid or metamizol treatment
written consent
ability to use a Patient-controlled analgesia device

Key exclusion criteria (6 listed)

cesarean in general anaesthesia
use of peridural catheter for pre-, peri- or post cesarean analgesia
additional post cesarean metamizol use
allergy/hypersensitivity to morphine, oxycodon, acetaminophen or ibuprofen
chronic use of general anaesthesia

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Oral OxycodonPatients assigned to the oral analgesia group received 20mg oxycodon at fixed intervals: 2 hours (h) and between 12h and 14h after cesarean.	Drug	Oxycodon
PiritramidPatients assigned to the PCA group received a single use intravenous PCA device (Vygon, Medical Products, Aachen, Germany) with a 30ml deposit of 9% sodium chloride solution containing 60mg piritramide. Bolus injection of 0.5ml was administered by the patient herself if needed, with a lock out interval of 5 minutes Patients assigned to the oral analgesia group received 20mg oxycodon at fixed intervals: 2 hours (h) and between 12h and 14h after cesarean. The PCA was discontinued after 24 hours or earlier if demanded.	Drug	Patient controlled analgesia (PCA) device with Pritramid

Primary outcome

Difference of Pain Scores on the Visual Analog Scale
Time frame: Pain level was evaluated before therapy (2h after CS), 12h, 24h, 32h, 40h, 48 and 72h after CS.
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).

4 secondary outcomes

Subgroups
Time frame: 6 month
Side Effects
Time frame: 6 month
Mobilisation
Time frame: 6 month
Costs
Time frame: 6 month

Results and safety

Results posted to the registry on 15 Feb 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Oxycodon	113	113
Patient Controlled Device With Pritramid	126	126

Primary outcome: Difference of Pain Scores on the Visual Analog Scale

Time frame: Pain level was evaluated before therapy (2h after CS), 12h, 24h, 32h, 40h, 48 and 72h after CS.. Mean (Standard Deviation). Unit: VAS score at 24 hours

Measure	Oxycodon n = 113	Patient Controlled Device With Pritramid n = 126
Value	5.88 (2.01)	4.85 (2.23)

Oxycodon vs Patient Controlled Device With Pritramid: Mean Difference (Net): 0.05, p <0.05, Chi-squared

Population analysed: 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.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Oxycodon	0 of 113 (0%)	0 of 113 (0%)	Not reported
Patient Controlled Device With Pritramid	0 of 126 (0%)	0 of 126 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 15715617Stamer UM, Wiese R, Stuber F, Wulf H, Meuser T. Change in anaesthetic practice for Caesarean section in Germany. Acta Anaesthesiol Scand. 2005 Feb;49(2):170-6. doi: 10.1111/j.1399-6576.2004.00583.x.
Background: PubMed 16580284Davis KM, Esposito MA, Meyer BA. Oral analgesia compared with intravenous patient-controlled analgesia for pain after cesarean delivery: a randomized controlled trial. Am J Obstet Gynecol. 2006 Apr;194(4):967-71. doi: 10.1016/j.ajog.2006.02.025.
Background: PubMed 12638399Gammaitoni AR, Galer BS, Bulloch S, Lacouture P, Caruso F, Ma T, Schlagheck T. Randomized, double-blind, placebo-controlled comparison of the analgesic efficacy of oxycodone 10 mg/acetaminophen 325 mg versus controlled-release oxycodone 20 mg in postsurgical pain. J Clin Pharmacol. 2003 Mar;43(3):296-304. doi: 10.1177/0091270003251147.
Background: PubMed 16192541Carvalho B, Cohen SE, Lipman SS, Fuller A, Mathusamy AD, Macario A. Patient preferences for anesthesia outcomes associated with cesarean delivery. Anesth Analg. 2005 Oct;101(4):1182-1187. doi: 10.1213/01.ane.0000167774.36833.99.
Derived from this study: PubMed 22622852Dieterich M, Muller-Jordan K, Stubert J, Kundt G, Wagner K, Gerber B. Pain management after cesarean: a randomized controlled trial of oxycodone versus intravenous piritramide. Arch Gynecol Obstet. 2012 Oct;286(4):859-65. doi: 10.1007/s00404-012-2384-5. Epub 2012 May 24.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Max Dieterich, MD principal investigator

University of Rostock, Department of Obstetrics and Gynecology

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Oral Oxycodon and Piritramid in people with Pain, run by Max Dieterich at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Feb 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference of Pain Scores on the Visual Analog Scale (time frame: Pain level was evaluated before therapy (2h after CS), 12h, 24h, 32h, 40h, 48 and 72h after CS.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01115101, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2016.