Quality of postoperative pain control and incidence and severity of nausea, vomiting, constipation, sedation, vertigo and somnolence during the treatment of postoperative pain with Palexia® compared to Targin®.

Quality of analgesia and side effect incidence and severity during postoperative pain management with Palexia® compared to Targin® - Palexia compared to Targin in postoperative pain.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-003238-15-DE

Enrollment

266

Registered

2012-10-24

Start date

2012-12-12

Completion date

Unknown

Last updated

2016-12-05

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

Conditions

Management of postoperative pain in trauma surgery patients (adults) requiring postoperative opiates for the management of postoperative pain. MedDRA version: 14.1 Level: LLT Classification code 10036236 Term: Postoperative pain relief System Organ Class: 100000004865

Interventions

Trade Name: Palexia retard® Product Name: Palexia retard® Pharmaceutical Form: Prolonged-release tablet INN or Proposed INN: Tapentadol CAS Number: 175591-23-8 Other descriptive name: TAPENTADOL Conc

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adult trauma patients ASA I-III requiring postoperative opiates for the management of pain Surgical treatment required Age > 18 Years Subjects must have signed an informed consent form indicating that they understand the purpose of and procedures required for the trial and are willing to participate in it 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 166 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: Patients unable to give informed consent Pregnant or breast-feeding women Pre- existing chronic pain treated with opiates Severe renal or hepatic impairment Treatment with MAO- inhibitors

Design outcomes

Primary

Measure	Time frame
Secondary Objective: Mean NRS-levels at rest, any unexpected side effect (AE and SAE) up to at least one week following surgery, detailed study of each side effect in the primary endpoint, its severity and therapeutic requirements, required dose of study- and control drug, dose of additional non-opioid-analgesics (dipyrone or paracetamol, ibuprofen or coxib), required rescue medication, preoperative opioid requirement, requirement of i.v. piritramid in the recovery room, total duration of postoperative opioid requirement, patient satisfaction at the end of the study period (5 days postoperative), eventually results of a prolonged observation period;Primary end point(s): There are 2 co- primary endpoints: • Analgesic efficacy revealed by the mean reduction of the pain level on a numeric rating scale (NRS) from 0-10 during exercise Analgesic efficacy will be assessed by quantifying the patients’ pain intensity level on the NRS during exercise once daily by the blinded investigator. The primary endpoint is the mean NRS level over the 5 days observation period. • Safety revealed by the incidence and severity of side-effect events A total of six opioid-induced side effects will be studied (nausea, vomiting, constipation, sedation, vertigo, somnolence). The severity of the side effects will be rated 0-2 where 0 is absence of respective side effect, 1 is side effect observed but no requirement for intervention, 2 is side effect requiring intervention. An “event” for the respective side effect will be defined when the sum score for the respective side effect over the 5 days observation period (maximum: 10) exceeds a pre-defined level of either 1 or 3. An event for the respective side effect is defined as follows: The patient had relevant side effects at a sum score over the 5-days observation period of • constipation = 1, and/or • nausea = 3, and/or • vomiting = 3, and/or • somnolence = 1, and/or • sedation = 3, and/or • vertigo = 3. for each side effect and/or at	—

Measure

Time frame

Secondary Objective: Mean NRS-levels at rest, any unexpected side effect (AE and SAE) up to at least one week following surgery, detailed study of each side effect in the primary endpoint, its severity and therapeutic requirements, required dose of study- and control drug, dose of additional non-opioid-analgesics (dipyrone or paracetamol, ibuprofen or coxib), required rescue medication, preoperative opioid requirement, requirement of i.v. piritramid in the recovery room, total duration of postoperative opioid requirement, patient satisfaction at the end of the study period (5 days postoperative), eventually results of a prolonged observation period;Primary end point(s): There are 2 co- primary endpoints: • Analgesic efficacy revealed by the mean reduction of the pain level on a numeric rating scale (NRS) from 0-10 during exercise Analgesic efficacy will be assessed by quantifying the patients’ pain intensity level on the NRS during exercise once daily by the blinded investigator. The primary endpoint is the mean NRS level over the 5 days observation period. • Safety revealed by the incidence and severity of side-effect events A total of six opioid-induced side effects will be studied (nausea, vomiting, constipation, sedation, vertigo, somnolence). The severity of the side effects will be rated 0-2 where 0 is absence of respective side effect, 1 is side effect observed but no requirement for intervention, 2 is side effect requiring intervention. An “event” for the respective side effect will be defined when the sum score for the respective side effect over the 5 days observation period (maximum: 10) exceeds a pre-defined level of either 1 or 3. An event for the respective side effect is defined as follows: The patient had relevant side effects at a sum score over the 5-days observation period of • constipation = 1, and/or • nausea = 3, and/or • vomiting = 3, and/or • somnolence = 1, and/or • sedation = 3, and/or • vertigo = 3. for each side effect and/or at

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Secondary

Measure	Time frame
Secondary end point(s): • Mean NRS-levels at rest, • Any unexpected side effect (AE and SAE) up to at least one week following surgery, • Detailed study of each side effect in the primary endpoint, its severity and therapeutic requirements, • Required dose of study- and control drug, dose of additional non-opioid-analgesics (dipyrone or paracetamol, ibuprofen or coxib), • Required rescue medication, • Preoperative opioid requirement, • Requirement of i.v. piritramid in the recovery room, • Total duration of postoperative opioid requirement, • Patient satisfaction at the end of the study period (5 days postoperative), • Eventually results of a prolonged observation period when patients cannot be discharged as scheduled ;Timepoint(s) of evaluation of this end point: The non-blinded staff involved in patient care will obtain these endpoints 3-times daily.	—

Measure

Time frame

Secondary end point(s): • Mean NRS-levels at rest, • Any unexpected side effect (AE and SAE) up to at least one week following surgery, • Detailed study of each side effect in the primary endpoint, its severity and therapeutic requirements, • Required dose of study- and control drug, dose of additional non-opioid-analgesics (dipyrone or paracetamol, ibuprofen or coxib), • Required rescue medication, • Preoperative opioid requirement, • Requirement of i.v. piritramid in the recovery room, • Total duration of postoperative opioid requirement, • Patient satisfaction at the end of the study period (5 days postoperative), • Eventually results of a prolonged observation period when patients cannot be discharged as scheduled ;Timepoint(s) of evaluation of this end point: The non-blinded staff involved in patient care will obtain these endpoints 3-times daily.

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Countries

Germany

Contacts

Public ContactAnaesthesia department secretary

Department anaesthesia and intensive care medicine

g.haeseler@kkrn.de00492365911491

Outcome results

None listed

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