NCT03701256

Brief Summary

A monocentric, prospective, randomized controlled trial, including patients proposed for a laparoscopic gynecologic surgery comparing the muscular relaxing effect of a bilateral ultrasound-guided Transversus Abdominis Plane block to usual neuromuscular blockade agent (Atracurium)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2015

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

February 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2015

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

October 7, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
Last Updated

October 17, 2018

Status Verified

October 1, 2018

Enrollment Period

6 months

First QC Date

October 7, 2018

Last Update Submit

October 15, 2018

Conditions

Neuromuscular BlockadeRegional Anesthesia

Keywords

TAP blockcurarelaparoscopygynecology surgeryabdominal compliance

Outcome Measures

Primary Outcomes (2)

  • Abdominal compliance (Ca)

    Ca calculation was based on the formula: Ca= ΔV/ΔP with ΔV and ΔP referring to the volume variation of CO2 insufflated and ΔP to the variation of intraabdominal pressure during the procedure

    peroperatively every 10 minute from the introduction of the laparoscopy trocars until their removal

  • surgeon satisfaction

    Surgeons were asked at the end of the procedure about their satisfaction. Their answers were put on a scale between 1 and 4 (1: poor, 2: average, 3: good, 4: excellent)

    peroperatively

Secondary Outcomes (8)

  • Heart Rate (HR) (bpm)

    peropertively from the laparoscopy trocars introduction until skin closure

  • Mean arterial pressure (MAP) (mmHg)

    peropertively from the laparoscopy trocars introduction until skin closure

  • SpO2 (%)

    peropertively from the laparoscopy trocars introduction until skin closure

  • PetCO2 (mmHg)

    peropertively from the laparoscopy trocars introduction until skin closure

  • Pp (cmH2O)

    peopertively from the laparoscopy trocars introduction until skin closure

  • +3 more secondary outcomes

Study Arms (2)

TAP Group

EXPERIMENTAL

Bilateral ultrasound TAP bloc performed via 20 ml of 2.5% bupivacaine without neuromuscular blocking agents

Procedure: Bilateral ultrasound guided TAP bloc

TRAC Group

ACTIVE COMPARATOR

Neuromuscular blocking agent: Atracurium 0.1 mg/kg per bolus

Drug: Neuromuscular blockade agent: Atracurium 01mg/kg per bolus

Interventions

Bilateral ultrasound guided TAP blocPROCEDURE

In the TAP group: Bilateral ultrasound guided TAP bloc for laparoscopic gynecologic surgery

TAP Group
Neuromuscular blockade agent: Atracurium 01mg/kg per bolusDRUG

In the TRAC group: Neuromuscular blockade agent: Atracurium 01mg/kg per bolus for maintaining muscular relaxation and immobilization during laparoscopic gynecologic surgery

TRAC Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Association of anesthesiologists' class I to III (ASA I to ASA III)
  • undergoing laparoscopic gynecologic procedures
  • patients' refusal to be part of the study
  • ASA IV and higher
  • known allergic history to Propofol or any of its components (eggs, soya and beans, etc.), suxamethonium, Fentanyl or Atracurium.
  • Patients who presents any regional anesthesia contraindication as clotting disorders, injection site infection and allergy to local anesthetics
  • Psychiatric and neurologic disorders and the inability to understand pain scores and the study protocol

You may not qualify if:

  • unsuccessful TAP block
  • Observed anesthesia or surgical incident which requires the end of the ongoing procedure or the conversion to laparotomy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tunis maternity and neonatology center,

Tunis, 1007, Tunisia

Location

Study Officials

  • Hayen Maghrebi, Professor

    Tunis Maternity Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 7, 2018

First Posted

October 9, 2018

Study Start

February 1, 2015

Primary Completion

July 31, 2015

Study Completion

October 31, 2015

Last Updated

October 17, 2018

Record last verified: 2018-10

Locations

TU(1)