Transversus Abdominis Plane Block in the Management of Acute Postoperative Pain Syndrome After Caesarean Section

Study Overview
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Brief Summary
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In many countries, caesarean section (CS) rates have been increasing. The international literature is unclear regarding the analgesic efficacy of the transversus abdominis plane block (TAPB) after a CS. In particular, no clinical trials exist in which the correct method of performing this block has been matched with the obtained analgesic effect after a CS. The primary goal of the study was to determine whether a correctly performed ultrasound-guided TAPB (USG-TAPB) could provide patients who underwent a CS with better control of acute postoperative pain during the first 72 hours after surgery

Detailed Description
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Transversus abdominis plane block (TAPB) is a regional anesthetic technique that can provide analgesia for lower abdominal surgical procedures. Previous meta-analyses and recently published clinical trials have demonstrated promising results for this technique when it is used as part of multimodal postoperative pain treatment, but no consensus exists regarding the potency of this type of anesthetic procedure for analgesia after a CS. The primary goal of the study was to determine whether a correctly performed ultrasound-guided TAPB (USG-TAPB) could provide patients who underwent a CS with better control of acute postoperative pain during the first 72 hours after surgery. In this study, the correct execution of an USG-TAPB was verified, and then the procedure was matched with the obtained analgesic effect after a CS. The secondary aims were to determine whether USG-TAPB could ensure a decline in postoperative requests for opiates and fewer opiate-related side effects, the return of faster bowel function, and shorter recovery time without generating critical hemodynamic changes.

Official Title
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Ultrasound-guided Transversus Abdominis Plane Block in the Management of Acute Postoperative Pain Syndrome After Caesarean Section: a Double-blind Randomized Controlled Clinical Trial

Conditions
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Pain

Intervention / Treatment
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* Drug: Levobupivacaine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologists (ASA) physical status I-III Caesarian Section. The Pfannenstiel incision was performed. Exclusion Criteria: body mass index (BMI) >35 allergy to local anesthetics skeletal and/or muscle abnormalities of the spine primary and/or secondary neurological diseases psychiatric diseases history of chronic pain and/or neuropathic disorders history of drug abuse state of sepsis infection and/or tumors within the skin on the back primary or secondary coagulopathies pre-eclampsia or eclampsia.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Levobupivacaine 100 mg, USG TAP Block<br>100 mg of Levobupivacaine by intramuscular injection, at the end of surgery | Drug: Levobupivacaine<br>* 100 mg of Levobupivacaine by intramuscular injection, at the end of surgery<br>* Other names: Chirocaine;|
| Placebo Comparator: Placebo<br>20 ml of Saline (for 100 mg Levobupivacaine) intramuscularly, at the end of surgery | Drug: Saline<br>* 20 ml of saline saline by intramuscular injection, at the end of surgery<br>* Other names: Saline solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain (Numeric Rate Scale) at 72 hours after surgery | The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine or worst pain imaginable). | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction at 72 hours from surgery | Descriptive scale of satisfaction in four step: not at all/slightly/somewhat/very satisfied) | 72 hours | 
| The time of recovery of bowel function at 72 hours from surgery | Time (in hours) to have defacation | 72 hours | 
| The time of hospital discharge at 72 hours after surgery | Time (days after surgery) for hospital discharging | 72 hours | 
| The consumption of painkillers at 72 hours after surgery | The equianalgesic dose (in mg) of morphine. | 72 hours | 
| The healing of the surgical wound at 72 hours | Descriptive scale of four step: unacceptable/acceptable/excellent healing | 72 hours |