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Het effect van een TAP-blok op de postoperatieve pijnbestrijding na een gecombineerde spinaal-epidurale (ruggenprik) anesthesie voor een keizersnede.

The effect of transversus abdominis plane block on postoperative analgesia after combined spinal epidural anesthesia for Cesarean delivery.

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2015-001126-41-BE
Enrollment
Unknown
Registered
2015-06-15
Start date
2015-07-10
Completion date
Unknown
Last updated
2016-08-22

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

Conditions

providing adequate analgesia after cesarean delivery.

Interventions

Trade Name: Naropin Product Name: Naropin Pharmaceutical Form: Injection INN or Proposed INN: ROPIVACAINE CAS Number: 84057-95-4 Concentration unit: ml millilitre(s) Concentration type: equal Concentr

Sponsors

University Hospitals Leuven
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - obtained written consent from the patiënt. - Patiënt presenting for elective cesarean section. 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 200 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - age<18 years. - epidural analgesia started during labour. - preterm gestation (<37w ) - multiple gestations - contraindications for neuraxial anesthesia - intolerance to any of the study drugs - chronic steroid use - chronic opioid use - diabetes

Design outcomes

Primary

MeasureTime frame
Main Objective: we want to test the hypothesis that a USG QL block decreases postoperative morphine consumption compared to a control group, a “blind” approach posterior TAP block and an USG lateral TAP block after cesarean delivery.;Secondary Objective: not applicable;Primary end point(s): Total morphine consumption during the first 48 hours.;Timepoint(s) of evaluation of this end point: 6, 12, 24, 48 hours post-operative.

Secondary

MeasureTime frame
Secondary end point(s): - Pain scores. - sensory block postoperative nausea and vomiting. - the development of persistent pain. - Overall patient satisfaction;Timepoint(s) of evaluation of this end point: - pain scores : 6,12,24 and 48 hours after delivery both during rest and mobilization. - sensory block :pinpricks at 6,12,24 and 48 hours. - the development of persistent pain : after 6 months and 1 year. - Overall patient satisfaction : after 48 hours.

Countries

Belgium

Contacts

Public ContactResearch department anesthesiology

University Hospitals Leuven

christel.hugyens@uzleuven.be+32 16 344620

Outcome results

None listed

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