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

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

Study Overview

• Status: Terminated
• Conditions: Pain
• Intervention / Treatment: Drug: Levobupivacaine; Drug: Saline

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.

• Study Type: Interventional
• Enrollment (Actual): 96
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Levobupivacaine 100 mg, USG TAP Block; 100 mg of Levobupivacaine by intramuscular injection, at the end of surgery	Drug: Levobupivacaine; 100 mg of Levobupivacaine by intramuscular injection, at the end of surgery; Other Names: Chirocaine
Placebo Comparator: Placebo; 20 ml of Saline (for 100 mg Levobupivacaine) intramuscularly, at the end of surgery	Drug: Saline; 20 ml of saline saline by intramuscular injection, at the end of surgery; Other Names: Saline solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain (Numeric Rate Scale) at 72 hours after surgery	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction at 72 hours from surgery	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	Time (in hours) to have defacation	72 hours
The time of hospital discharge at 72 hours after surgery	Time (days after surgery) for hospital discharging	72 hours
The consumption of painkillers at 72 hours after surgery	The equianalgesic dose (in mg) of morphine.	72 hours
The healing of the surgical wound at 72 hours	Descriptive scale of four step: unacceptable/acceptable/excellent healing	72 hours

Collaborators and Investigators

• Sponsor: Emiliano Petrucci

Publications and helpful links

General Publications

• Fusco P, Cofini V, Petrucci E, Scimia P, Pozone T, Paladini G, Carta G, Necozione S, Borghi B, Marinangeli F. Transversus Abdominis Plane Block in the Management of Acute Postoperative Pain Syndrome after Caesarean Section: A Randomized Controlled Clinical Trial. Pain Physician. 2016 Nov-Dec;19(8):583-591.

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: March 15, 2016
• First Submitted That Met QC Criteria: April 4, 2016
• First Posted (Estimate): April 5, 2016

Study Record Updates

• Last Update Posted (Actual): August 12, 2020
• Last Update Submitted That Met QC Criteria: August 10, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Levobupivacaine
• Other Study ID Numbers: 0057864/13

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No