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

Emiliano Petrucci

Status and phase: Terminated; Phase 3

Conditions: Pain

Treatments: Drug: Saline; Drug: Levobupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02728323

0057864/13

Details and patient eligibility

About

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

Full 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.

Enrollment: 96 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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96 participants in 2 patient groups, including a placebo group

Levobupivacaine 100 mg, USG TAP Block

Active Comparator group

Description:

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

Treatment:

Drug: Levobupivacaine

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Saline