Trial | NCT02728323  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Terminated

  • Indication/Condition

    Pain

  • Study Participants

    96
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
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.
Study Started
Oct 31
2013
Primary Completion
Sep 30
2015
Study Completion
Oct 31
2015
Last Update
Aug 12
2020

Drug Levobupivacaine

100 mg of Levobupivacaine by intramuscular injection, at the end of surgery

  • Other names: Chirocaine

Drug Saline

20 ml of saline saline by intramuscular injection, at the end of surgery

  • Other names: Saline solution

Levobupivacaine 100 mg, USG TAP Block Active Comparator

100 mg of Levobupivacaine by intramuscular injection, at the end of surgery

Placebo Placebo Comparator

20 ml of Saline (for 100 mg Levobupivacaine) intramuscularly, at the end of surgery

Criteria 

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.
No Results Posted