NCT02728323

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P25-P50 for phase_3 pain

Timeline
Completed

Started Oct 2013

Typical duration for phase_3 pain

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2016

Completed
21 days until next milestone

First Posted

Study publicly available on registry

April 5, 2016

Completed
Last Updated

August 12, 2020

Status Verified

August 1, 2020

Enrollment Period

1.9 years

First QC Date

March 15, 2016

Last Update Submit

August 10, 2020

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Patient satisfaction at 72 hours from surgery

    72 hours

  • The time of recovery of bowel function at 72 hours from surgery

    72 hours

  • The time of hospital discharge at 72 hours after surgery

    72 hours

  • The consumption of painkillers at 72 hours after surgery

    72 hours

  • The healing of the surgical wound at 72 hours

    72 hours

Study Arms (2)

Levobupivacaine 100 mg, USG TAP Block

ACTIVE COMPARATOR

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

Drug: Levobupivacaine

Placebo

PLACEBO COMPARATOR

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

Drug: Saline

Interventions

LevobupivacaineDRUG

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

Also known as: Chirocaine
Levobupivacaine 100 mg, USG TAP Block
SalineDRUG

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

Also known as: Saline solution
Placebo

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiologists (ASA) physical status I-III
  • Caesarian Section. The Pfannenstiel incision was performed.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 27906937DERIVED

MeSH Terms

Conditions

Pain

Interventions

LevobupivacaineSodium ChlorideSaline Solution

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BupivacaineAnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Pierfrancesco Fusco, MD

    Anesthesia and Intensive care Unit, San Salvatore Academic Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Anesthesist

Study Record Dates

First Submitted

March 15, 2016

First Posted

April 5, 2016

Study Start

October 1, 2013

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

August 12, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share