Pain
Conditions
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.
Interventions
DRUGLevobupivacaine
100 mg of Levobupivacaine by intramuscular injection, at the end of surgery
DRUGSaline
20 ml of saline saline by intramuscular injection, at the end of surgery
Sponsors
Emiliano Petrucci
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 consumption of painkillers at 72 hours after surgery | 72 hours | The equianalgesic dose (in mg) of morphine. |
| The healing of the surgical wound at 72 hours | 72 hours | Descriptive scale of four step: unacceptable/acceptable/excellent healing |
Outcome results
None listed