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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

96 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-10-31

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Levobupivacaine 100 mg, USG TAP Block

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

Group Type ACTIVE_COMPARATOR

Levobupivacaine

Intervention Type DRUG

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

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

Interventions

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Levobupivacaine

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

Intervention Type DRUG

Saline

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

Intervention Type DRUG

Other Intervention Names

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Chirocaine Saline solution

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes