Transversus Abdominis Plane Block in the Management of Acute Postoperative Pain Syndrome After Caesarean Section
- Registration Number
- NCT02728323
- Lead Sponsor
- Emiliano Petrucci
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 96
- American Society of Anesthesiologists (ASA) physical status I-III
- Caesarian Section. The Pfannenstiel incision was performed.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Saline 20 ml of Saline (for 100 mg Levobupivacaine) intramuscularly, at the end of surgery Levobupivacaine 100 mg, USG TAP Block Levobupivacaine 100 mg of Levobupivacaine by intramuscular injection, at the end of surgery
- Primary Outcome Measures
Name Time Method Postoperative pain (Numeric Rate Scale) at 72 hours after surgery 72 hours 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").
- Secondary Outcome Measures
Name Time Method The consumption of painkillers at 72 hours after surgery 72 hours The equianalgesic dose (in mg) of morphine.
Patient satisfaction at 72 hours from surgery 72 hours Descriptive scale of satisfaction in four step: not at all/slightly/somewhat/very satisfied)
The time of recovery of bowel function at 72 hours from surgery 72 hours Time (in hours) to have defacation
The time of hospital discharge at 72 hours after surgery 72 hours Time (days after surgery) for hospital discharging
The healing of the surgical wound at 72 hours 72 hours Descriptive scale of four step: unacceptable/acceptable/excellent healing