Comparison of Two Pain-treatment Techniques After Cesarean Section

Study Overview
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Brief Summary
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Comparison of two types of analgesia after cesarean section. All patients will anaesthetised with spinal technique. Ultrasound-guided transversus abdominis plane or quadratus lumborum block to treat postoperative pain. Postoperative pain will measured with visual-analogue 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 anaesthetised 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 (0.25 % bupivacaine) on each side. Postoperative pain will be measured with VAS (visual-analogue scale) 2, 4, 8, 12 and 24 hours after the end of operation. Paracetamol, metamizol, 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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Effectiveness of Transversus Abdominis Plane Block Versus Quadratus Lumborum Technique in Patients After Cesarean Section

Conditions
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Cesarean Section, Pain Management, Neuropathic Pain

Intervention / Treatment
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* Procedure: TAP (transversus abdominis plane block)
* Procedure: QL (quadratus lumborum block)
* Drug: Bupivacaine
* Device: Needle
* Drug: Paracetamol
* Drug: Metamizol
* Drug: Ketoprofen
* Drug: Morphine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: obtained consent singleton pregnancy subarachnoid anaesthesia Exclusion Criteria: coagulopathy allergy to 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: 75 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAP (transversus abdominis plane)<br>Ultrasound-guided transversus abdominis plane block at the end of cesarean section | Procedure: TAP (transversus abdominis plane block)<br>* ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.25% bupivacaine administered (0.2 mL/kg).<br>Drug: Bupivacaine<br>* In both groups (TAP&QL) 0.25% bupivacaine 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: Metamizol<br>* Intravenous metamizol 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: QL (quadratus lumborum)<br>Ultrasound-guided quadratus lumborum block at the end of cesarean section | Procedure: QL (quadratus lumborum block)<br>* ultrasound-guided regional block between abdominal wall muscles to treat acute pain, similar to transversus abdominis plane block, but with 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: Bupivacaine<br>* In both groups (TAP&QL) 0.25% bupivacaine 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: Metamizol<br>* Intravenous metamizol 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 measured with VAS | Acute pain measured with VAS (visual-analogue scale). | up to 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropathic pain assessed with NPSI | Neuropathic pain occurrence with Neuropathic Pain Symptom Inventory (NPSI) | 6 months from the surgery | 

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