Regional Analgesia After Cesarean Section

Study Overview
=================
Brief Summary
-----------------
All patients will be anaesthetized with spinal technique. Each patient will be treated with intravenous morphine - patient controlled analgesia (PCA). 2 of 3 groups of patients will receive ultrasound-guided transversus abdominis plane or quadratus lumborum block to treat postoperative pain. Postoperative pain will measured with visual-analogue scale (VAS). Total morphine consumption and time to the first demand will be noted. 1, 2, 6 months after surgery each patient will be called to assess neuropathic pain with Neuropathic Pain Symptom Inventory (NPSI).

Detailed Description
-----------------
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. All patients will receive PCA (patient controlled analgesia) pump with morphine (1 mg/mL, 5 minute interval, no loading dose) after transfer to PACU (post-anesthesia care unit). In PACU vital signs will be monitored. Each patient will be randomly assigned to one of three groups. In the first group of patients no additional regional analgesia will be performed. In the second and the third group, ultrasound-guided transversus abdominis plane or quadratus lumborum block will be done with 0.375 % ropivacaine (0.2 ml per kg 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. 1, 3, 6 months patients will be called to assess neuropathic pain. Neuropathic Pain Symptom Inventory (NPSI) will be used.

Official Title
-----------------
Efficacy of Regional Analgesia Techniques (Quadratus Lumborum Block and Transversus Abdominis Plane Block) in Acute and Chronic Pain Treatment in Patients After Cesarean Delivery

Conditions
-----------------
Cesarean Section, Pain, Postoperative, Pain, Neuropathic

Intervention / Treatment
-----------------
* Procedure: TAP (transversus abdominis plane block)
* Procedure: QLB (quadratus lumborum block)
* Device: Stimuplex Ultra 360 needle
* Drug: Ropivacaine
* Drug: Paracetamol
* Procedure: subarachnoid anesthesia
* Procedure: PCA (patient controlled analgesia)
* Drug: Metamizol
* Drug: Ketoprofen
* Drug: Bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: obtained consent singleton pregnancy subarachnoid anaesthesia Exclusion Criteria: coagulopathy allergy to morphine and local anesthetics depression, antidepressant drugs treatment epilepsy usage of painkiller before surgery addiction to alcohol or recreational drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants were randomized 1:1:1
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PCA<br>Subarchnoid anesthesia with bupivacaine PCA with morphine in the PACU | Drug: Paracetamol<br>* Intravenous paracetamol will be used (1.0 gram), up to 4 grams per day<br>Procedure: subarachnoid anesthesia<br>* subarachnoid anesthesia for each patients participating in the study with pencil point needle<br>Procedure: PCA (patient controlled analgesia)<br>* All patients will receive PCA pump with morphine (1 mg/mL, 5 minute interval, no loading dose) after transfer to PACU (post-anesthesia care unit)<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: Bupivacaine<br>* Subarachnoid anesthesia with spinal bupivacaine (MARCAINE SPINAL 0.5% HEAVY)<br>* Other names: Marcaine;|
| Experimental: TAP<br>Subarchnoid anesthesia with bupivacaine TAP (transversus abdominis plane block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section. PCA with morphine in the PACU | Procedure: TAP (transversus abdominis plane block)<br>* ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain<br>Device: Stimuplex Ultra 360 needle<br>* ultrasound-guided needle will be used for QLB and TAP and regional blocks<br>Drug: Ropivacaine<br>* 0.375 % ropivacaine will be administered for both QLB and TAP (0.2 mL per kg on both sides)<br>Drug: Paracetamol<br>* Intravenous paracetamol will be used (1.0 gram), up to 4 grams per day<br>Procedure: subarachnoid anesthesia<br>* subarachnoid anesthesia for each patients participating in the study with pencil point needle<br>Procedure: PCA (patient controlled analgesia)<br>* All patients will receive PCA pump with morphine (1 mg/mL, 5 minute interval, no loading dose) after transfer to PACU (post-anesthesia care unit)<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: Bupivacaine<br>* Subarachnoid anesthesia with spinal bupivacaine (MARCAINE SPINAL 0.5% HEAVY)<br>* Other names: Marcaine;|
| Experimental: QLB<br>Subarchnoid anesthesia with bupivacaine QLB (quadratus lumborum block) ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375 % ropivacaine administered (0.2 mL/kg) at the and of cesarean section. PCA with morphine in the PACU | Procedure: QLB (quadratus lumborum block)<br>* ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain<br>Device: Stimuplex Ultra 360 needle<br>* ultrasound-guided needle will be used for QLB and TAP and regional blocks<br>Drug: Ropivacaine<br>* 0.375 % ropivacaine will be administered for both QLB and TAP (0.2 mL per kg on both sides)<br>Drug: Paracetamol<br>* Intravenous paracetamol will be used (1.0 gram), up to 4 grams per day<br>Procedure: subarachnoid anesthesia<br>* subarachnoid anesthesia for each patients participating in the study with pencil point needle<br>Procedure: PCA (patient controlled analgesia)<br>* All patients will receive PCA pump with morphine (1 mg/mL, 5 minute interval, no loading dose) after transfer to PACU (post-anesthesia care unit)<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: Bupivacaine<br>* Subarachnoid anesthesia with spinal bupivacaine (MARCAINE SPINAL 0.5% HEAVY)<br>* Other names: Marcaine;|

What is the study measuring?
-----------------
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 | 
| Morphine consumption | Total morphine consumption | up to 24 hours after surgery | 

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