Postoperative Analgesia With Transversus Abdominis Plane Block or Quadratus Lumborum Block in Patients After Cesarian Delivery
| Registry | NCT03404908 |
|---|---|
| Status | Completed |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 105 (Actual) |
| Sponsor | Medical University of Lublin (Other) |
| Conditions | Cesarean Section, Postoperative Pain |
| Interventions | TAP (transversus abdominis plane block), QL (quadratus lumborum block), Ropivacaine, Needle, paracetamol, metamizole, Ketoprofen, Morphine (Procedure, drug, device) |
| Dates | start 2018-02-07, primary completion 2019-01-14, completion 2019-04-17, first posted 2018-01-19, last updated 2023-11-24 |
| Locations | 1 site in Poland |
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All trials for Cesarean Section All trials for Postoperative Pain All trials of TAP (transversus abdominis plane block) All trials of QL (quadratus lumborum block)
Comparison of two types of analgesia after cesarean section All patients will be anesthetized with spinal technique. Ultrasound-guided transversus abdominis plane or quadratus lumborum block to treat postoperative pain. Postoperative pain will be measured with visual-analog scale (VAS). 1, 2, 6 months after surgery each patient will be called to assess neuropathic pain with Neuropathic Pain Symptom Inventory (NPSI).
Written consent will be obtained before the cesarean section. Only subarachnoidally anesthetized patients may participate in the study. Pencil-point spinal needle and bupivacaine (Marcaine Heavy Spinal 0.5 %) will be used.
At the end of surgery ultrasound-guided regional block will be performed. Each patient will be randomly allocated to one of the treated group: transversus abdominis plane block (TAP) or quadratus lumborum (QL). Patients receive 0.2 mL of local anesthetic solution (0.375 % ropivacaine) on each side.
Postoperative pain will be measured with VAS (visual-analog scale) 2, 4, 8, 12 and 24 hours after the end of the operation.
Paracetamol, metamizole, ketoprofen may be given as required. Whenever pain exceeds 40 (VAS) 5 mg of morphine will be given intravenously (maximum two dosages per day).
1, 3, 6 months patients will be called to assess neuropathic pain. Neuropathic Pain Symptom Inventory (NPSI) will be used.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| TAP | Experimental | Procedure: TAP (transversus abdominis plane block); Drug: Ropivacaine; Device: Needle; Drug: paracetamol; Drug: metamizole; Drug: Ketoprofen; Drug: Morphine | Ultrasound-guided transversus abdominis plane block at the end of cesarean section |
| QLB | Experimental | Procedure: QL (quadratus lumborum block); Drug: Ropivacaine; Device: Needle; Drug: paracetamol; Drug: metamizole; Drug: Ketoprofen; Drug: Morphine | Ultrasound-guided quadratus lumborum block at the end of cesarean section |
Sex: Female, ages: 18 Years to 70 Years
Inclusion Criteria: * obtained consent * singleton pregnancy * subarachnoid anesthesia Exclusion Criteria: * coagulopathy * allergy to local anesthetics * depression, antidepressant drugs treatment * epilepsy * usage of painkiller before surgery * addiction to alcohol or recreational drugs
| Facility | City | Country | Status |
|---|---|---|---|
| II Department of Anesthesia and Intensive Care, Medical University of Lublin | Lublin | Poland |