TAP vs QLB in Patients After Cesarean Delivery

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Postoperative Analgesia With Transversus Abdominis Plane Block or Quadratus Lumborum Block in Patients After Cesarian Delivery

Conditions
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Cesarean Section, Postoperative Pain

Intervention / Treatment
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* Procedure: TAP (transversus abdominis plane block)
* Procedure: QL (quadratus lumborum block)
* Drug: Ropivacaine
* Device: Needle
* Drug: paracetamol
* Drug: metamizole
* Drug: Ketoprofen
* Drug: Morphine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAP<br>Ultrasound-guided transversus abdominis plane block at the end of cesarean section | Procedure: TAP (transversus abdominis plane block)<br>* the ultrasound-guided regional block of abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375% ropivacaine administered (0.2 mL/kg).<br>Drug: Ropivacaine<br>* In both groups (TAP&QLB) 0.375% ropivacaine will be given (0.2 mL/kg)<br>Device: Needle<br>* Ultrasound-guided, Stimuplex ultra 360 needle will be used in the study<br>Drug: paracetamol<br>* Intravenous paracetamol will be used (1.0 gram), up to 4 grams per day<br>Drug: metamizole<br>* Intravenous metamizole will be used (1.0 gram), up to 4 grams per day<br>Drug: Ketoprofen<br>* Intravenous ketoprofen will be used (0.1 gram), up to 200 milligrams per day<br>Drug: Morphine<br>* Intravenous morphine (5 mg) will be given when pain exceeds 40 mm in VAS (maximum 2 doses per day)<br>|
| Experimental: QLB<br>Ultrasound-guided quadratus lumborum block at the end of cesarean section | Procedure: QL (quadratus lumborum block)<br>* the ultrasound-guided regional block of abdominal wall muscles to treat acute pain, similar to transversus abdominis plane block, but with a distribution of local anesthetic towards paravertebral space. Stimuplex Ultra 360 needle will be used and 0.25% bupivacaine administered (0.2 mL/kg).<br>Drug: Ropivacaine<br>* In both groups (TAP&QLB) 0.375% ropivacaine will be given (0.2 mL/kg)<br>Device: Needle<br>* Ultrasound-guided, Stimuplex ultra 360 needle will be used in the study<br>Drug: paracetamol<br>* Intravenous paracetamol will be used (1.0 gram), up to 4 grams per day<br>Drug: metamizole<br>* Intravenous metamizole will be used (1.0 gram), up to 4 grams per day<br>Drug: Ketoprofen<br>* Intravenous ketoprofen will be used (0.1 gram), up to 200 milligrams per day<br>Drug: Morphine<br>* Intravenous morphine (5 mg) will be given when pain exceeds 40 mm in VAS (maximum 2 doses per day)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Acute pain measured with VAS (visual-analogue scale). VAS in milimmeters. Minimum value 0, maximum 100. Less better - less severe pain. 0 no pain at all. | up to 24 hours after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropathic pain | Neuropathic pain occurrence assessed with Neuropathic Pain Symptom Inventory (NPSI) 10 descriptive variables, each one from 0 to 10. 0 means no pain. 10 very high chance of occurrence of neuropathic pain. | 6 months from the surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transversus abdominis plane block, quadratus lumborum block, neuropathic pain