Transversus Abdominis Plane Block in the Management of Acute Postoperative Pain Syndrome After Caesarean Section
Ultrasound-guided Transversus Abdominis Plane Block in the Management of Acute Postoperative Pain Syndrome After Caesarean Section: a Double-blind Randomized Controlled Clinical Trial
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 3
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Levobupivacaine 100 mg, USG TAP Block
100 mg of Levobupivacaine by intramuscular injection, at the end of surgery
|
100 mg of Levobupivacaine by intramuscular injection, at the end of surgery
Andra namn:
|
|
Placebo-jämförare: Placebo
20 ml of Saline (for 100 mg Levobupivacaine) intramuscularly, at the end of surgery
|
20 ml of saline saline by intramuscular injection, at the end of surgery
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Postoperative pain (Numeric Rate Scale) at 72 hours after surgery
Tidsram: 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").
|
72 hours
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Patient satisfaction at 72 hours from surgery
Tidsram: 72 hours
|
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
Tidsram: 72 hours
|
Time (in hours) to have defacation
|
72 hours
|
|
The time of hospital discharge at 72 hours after surgery
Tidsram: 72 hours
|
Time (days after surgery) for hospital discharging
|
72 hours
|
|
The consumption of painkillers at 72 hours after surgery
Tidsram: 72 hours
|
The equianalgesic dose (in mg) of morphine.
|
72 hours
|
|
The healing of the surgical wound at 72 hours
Tidsram: 72 hours
|
Descriptive scale of four step: unacceptable/acceptable/excellent healing
|
72 hours
|
Samarbetspartners och utredare
Sponsor
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 0057864/13
Plan för individuella deltagardata (IPD)
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