Optimising pain control after caesarean section - an evaluation if oxycodone can replace morphine and low potency opioids postoperatively. - Cesarean section and pain control

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-018450-12-SE

Enrollment

Registered

2010-06-24

Start date

2010-08-18

Completion date

Unknown

Last updated

2012-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain management after elective cesarean section. MedDRA version: 12.1 Level: LLT Classification code 10036276 Term: Postoperative analgesia

Interventions

Trade Name: OxyContin 10 mg Pharmaceutical Form: Tablet Trade Name: OxyContin 20 mg Product Name: OxyContin Product Code: 13831 Pharmaceutical Form: Tablet Trade Name: OxyNorm 5 mg Product Name: Oxy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Women undergoing elective cesarean section at the Karolinska University Hospital. Women who intend to breast feed. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Women with previous chronic pain, mental illness requiring medication, drug abuse or difficulties to communicate, severe pregnancy complications, premature delivery, medical disease that can be suspected to influence the wellbeing of the newborn baby, intolerance to opiates or other drugs used in the present study or participation in another clinical trial during the last month.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate if oral oxycodone will can substitute for intravenous morphine during the first 24 hours after cesarean section as well as substitute for codeine during the following 4 days. The mean and maximum NRS for pain assessment will be registred for each of the different time periods (0-6, 6-12, 12-24 and 24-48 hours) as well as cumulatively and for the whole period. ;Secondary Objective: The total amount of opiates (opiate equivalents) will be documented and compared between the groups. The patients evaluation of the whole postoperative period on a scale between 0 and 10 where 10 represents a completely satisfactory pain management. Comparison of parameters related to the mothers mobilization. Midwifes will be asked to estimate time used for drug administration. Specific security variables include: Apgar score and collection of samples from the umbilical cord for blood gas analysis. Evaluation of the potential effects of opiate exposure on the newborn babies by the neurologic and adaptive capacity score (NACS) (Amiel-Tison, 1982). Measurement of oxycodone levels in breast milk and in serum from mother and child. Weight development in the newborns. Registration of any complications in the newborns leading to specific control or treatment, e.g. bilirubin levels above the normal range.;Primary end point(s): To evaluate whether oxycodone is as effective and as safe as the protocol used today in our clinic. The next question is whether administration of a more long-acting opiate with more stable basic serum levels might also reduce the number of episodes with break-through pain. Possibly the oral administration will be less time consuming for the midwifes than intravenous injections.	—

Measure

Time frame

Main Objective: To investigate if oral oxycodone will can substitute for intravenous morphine during the first 24 hours after cesarean section as well as substitute for codeine during the following 4 days. The mean and maximum NRS for pain assessment will be registred for each of the different time periods (0-6, 6-12, 12-24 and 24-48 hours) as well as cumulatively and for the whole period. ;Secondary Objective: The total amount of opiates (opiate equivalents) will be documented and compared between the groups. The patients evaluation of the whole postoperative period on a scale between 0 and 10 where 10 represents a completely satisfactory pain management. Comparison of parameters related to the mothers mobilization. Midwifes will be asked to estimate time used for drug administration. Specific security variables include: Apgar score and collection of samples from the umbilical cord for blood gas analysis. Evaluation of the potential effects of opiate exposure on the newborn babies by the neurologic and adaptive capacity score (NACS) (Amiel-Tison, 1982). Measurement of oxycodone levels in breast milk and in serum from mother and child. Weight development in the newborns. Registration of any complications in the newborns leading to specific control or treatment, e.g. bilirubin levels above the normal range.;Primary end point(s): To evaluate whether oxycodone is as effective and as safe as the protocol used today in our clinic. The next question is whether administration of a more long-acting opiate with more stable basic serum levels might also reduce the number of episodes with break-through pain. Possibly the oral administration will be less time consuming for the midwifes than intravenous injections.

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Countries

Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026