Postoperative Analgesie and Antihyperalgesia of Tramadol and Acetaminophen peroral after Caesarean Section - Tramalstudie

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-005231-28-AT

Enrollment

120

Registered

2008-08-28

Start date

2008-10-01

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Pain after Cesarean Section in spinal anesthesia

Interventions

Trade Name: Zaldiar Pharmaceutical Form: Tablet INN or Proposed INN: Tramadol/Paracetamol CAS Number: 1-25827 Other descriptive name: Zaldiar Concentration unit: mg milligram(s) Concentration type: ra

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Female patients between 18 and 45 years, ASA-Status 1-2, BMI 19-29, that are scheduled for planned caesarean section and have given written informed consent, will be included Are the trial subjects under 18? no 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: Exclusion criteria are known allergies or hypersensitivities to evaluated drugs, history of pain syndrome, substance abuse, preeclampsia or eclampsia, deviation from standardised surgical procedure, treatment with magnesium sulfate, renal or hepatic impairment and deviations from the standardized anaesthetic treatment.

Design outcomes

Primary

Measure	Time frame
Main Objective: reducing evoked postperative pain after caesarean section;Secondary Objective: reducing total dose, side effects and hyperalgesia in pain treatment after caesarean section;Primary end point(s): Study objective is to evaluate the analgetic and antihyperalgetic potency of oral multi-dose tramadol and acetaminophen in combination and alone after Caesarean Section. In this study the following RESEARCH HYPOTHESIS will be tested: - Combining oral tramadol and acetaminophen is more effective in pain control than the use of tramadol alone - Combining tramadol and acetaminophen for postoperative pain control after Caesarean section reduces side-effects compared to the use of tramadol alone - The dosages of tramadol can be reduced - The combination has an additive antihyperalgetic effect	—

Measure

Time frame

Main Objective: reducing evoked postperative pain after caesarean section;Secondary Objective: reducing total dose, side effects and hyperalgesia in pain treatment after caesarean section;Primary end point(s): Study objective is to evaluate the analgetic and antihyperalgetic potency of oral multi-dose tramadol and acetaminophen in combination and alone after Caesarean Section. In this study the following RESEARCH HYPOTHESIS will be tested: - Combining oral tramadol and acetaminophen is more effective in pain control than the use of tramadol alone - Combining tramadol and acetaminophen for postoperative pain control after Caesarean section reduces side-effects compared to the use of tramadol alone - The dosages of tramadol can be reduced - The combination has an additive antihyperalgetic effect

—

Countries

Austria

Outcome results

None listed

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