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

Phase 1

Conditions: providing adequate analgesia after cesarean delivery.
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Registration Number: EUCTR2015-001126-41-BE

Lead Sponsor: niversity Hospitals Leuven

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: Not specified

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

- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Secondary end point(s): - Pain scores.<br>- sensory block postoperative nausea and vomiting.<br>- the development of persistent pain.<br>- 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.<br>- sensory block :pinpricks at 6,12,24 and 48 hours.<br>- the development of persistent pain : after 6 months and 1 year.<br>- Overall patient satisfaction : after 48 hours.