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Neuromuscular BlockadePhase 4NCT03701256

Bilateral Transversus Abdominis Plane Block Versus Atracurium During Laparoscopic Gynecology Procedures.

A Phase 4 study testing Bilateral ultrasound guided TAP bloc and Neuromuscular blockade agent: Atracurium 01mg/kg per bolus in people with Neuromuscular Blockade and Regional Anesthesia, run by University Tunis El Manar at 1 site in Tunisia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Neuromuscular Blockade, Regional Anesthesia
What is being tested?
Bilateral ultrasound guided TAP bloc and Neuromuscular blockade agent: Atracurium 01mg/kg per bolus
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteTunisia
Study dates
1 Feb 2015to 31 Oct 2015
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • American Association of anesthesiologists' class I to III (ASA I to ASA III)
  • undergoing laparoscopic gynecologic procedures
  • Non inclusion Criteria:
  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Tunisia1 site
  • Tunis maternity and neonatology center,

    Tunis, 1007

Other trials in Tunisia

About this study

Official title: Bilateral Transversus Abdominis Plane Block Versus Atracurium During Laparoscopic Gynecology Procedures. Do we Really Still Need the Systemic Neuromuscular Blocking Agents?

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)

Read the detailed description

We conducted a monocentric randomized single blinded controlled trial for six months starting from February 2015 until July 2015. Patients undergoing laparoscopic gynecologic procedures were included and randomly assigned in two groups receiving either an ultrasound guided TAP block (TAP group) or usual Neuromuscular blockade curare type: Atracurium (TRAC group). Randomization was simple and the allocation sequence was generated by a random number table via computer. The surgeon in charge was blinded about the performance of a TAP block.

Anesthesia protocol was almost the same in the two groups apart from the TAP block performance in the study group and the use of the neuromuscular blockade . No premedication was given to before the procedure. Monitoring was standard with a 5 leads electrocardioscope, non-invasive arterial pressure, pulsed oximetry (SpO2) and pressure of end tidal expired CO2 (PetCO2). Peripheral venous access was obtained and a 0.9 % saline vascular prefilling was done via an 18 or a 16 Gauges (G) percutaneous line in the non-dominant superior member. In the TRAC group, induction was given with 2.5 mg Propofol, 3 γ/kg Fentanyl and 0.6 mg/kg Atracurium. In The TAP group general anesthesia was induced, after a 3 minutes pre-oxygenation, with 3 γ/kg fentanyl, 2.5 mg/kg Propofol and 1mg/kg Suxamethonium. Thereafter the TAP block was performed under ultrasonography guidance with a Samsung (MySonoU6) transportable device and a linear high frequency 5-12 Megahertz transducer. The probe was oriented transversely on the antero-lateral abdominal wall and the image depth was set between 4 and 6 cm. Once anatomic structures were visualized and well distinct, the probe was moved posteriorly until the mid-axillary line between the 12th rib and the iliac crest. Operator should be able to identify from top to bottom: the subcutaneous fat tissue (hypo-echogenic), External Oblic Abdominal Muscle (EOAM), Internal Oblic Abdominal Muscle (IOAM), Transverse Abdominis Muscle (TAM) (heterogeneous), peritoneum (hyper-echogenic) and underneath intraabdominal organs both moving with respiration. The junction between the posterior fascia of the IOAM and the anterior fascia of the TAM is also hyper-echogenic and represent the region of interest as it is the local anesthetic injection site. The puncture was proceeded with 100 mm lenght needle 21 G (Vygon, France) needle witch progressed obliquely through the abdominal wall. Operator realized an in plane ultrasound guided approach. As soon as the tip of the needle was placed in the junction between the IOAM and TAM and the aspiration test negative, a priming of 3 ml local anesthetic injection was used in order to unsure a correct position of the needle. In this case the injectate would appear as a hypo-echogenic oval well-shaped volume spreading between the two muscle layers. An inaccurate injection was suspected by the absence of the described image. Intramuscular injection could appear as a poorly defined hyper-echogenic image within the muscle. Once the correct position verified, the rest of the 20 ml of the 2.5% bupivacaine is injected. The contralateral block was performed equally. Anesthesia was maintained by a total intravenous anesthesia in both groups. Fentanyl was systematically reinjected every 30 minutes and Propofol was infused at 8-10 mg/kg/h. In the TRAC group, Atracurium reinjections were guided by the monitoring of the NMB every 20 minute at a dose equal to 0.1mg/kg to be reevaluated after 5 minutes. In the TAP group, a rescue injection of NMB agent was indicated in case of diaphragmatic contractions, surgeons' complaint or patients' movement after optimization of narcosis by increasing propofol infusing speed to a maximum of 5 mg/kg/h beyond the baseline speed and checking analgesia. In both groups patients were ventilated on a volume assisted mode with 50 % of inspired fraction of Oxygen and 4-6 cmH2O of positive end expiratory pressure (PEEP) aiming to get an SpO2>95%. Tidal volume and respiratory rate were set as to maintain a PetCO2 between 30 and 45 mmHg. A nasogastric tube was inserted before trocars introduction (T0). Patients from the two study groups had a postoperative analgesia prescription including acetaminophen (1g/6h), Ketoprofen (100 mg/12h) and Nefopam (20mg/4h). A 5 mg subcutaneous morphine injection was considered as rescue analgesia.

Being tested
Bilateral ultrasound guided TAP bloc, Neuromuscular blockade agent: Atracurium 01mg/kg per bolus
Keywords
TAP block, curare, laparoscopy, gynecology surgery, abdominal compliance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Bilateral ultrasound guided TAP blocProcedure or surgery

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

  • 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

Study groups in NCT03701256
Study groupRoleWhat they receive
TAP GroupExperimentalBilateral ultrasound TAP bloc performed via 20 ml of 2.5% bupivacaine without neuromuscular blocking agents
Receives: Procedure: Bilateral ultrasound guided TAP bloc
TRAC GroupActive comparatorNeuromuscular blocking agent: Atracurium 0.1 mg/kg per bolus
Receives: Drug: Neuromuscular blockade agent: Atracurium 01mg/kg per bolus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

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

  2. 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)

    Measured: peroperatively

Secondary outcomes (8)
  1. Heart Rate (HR) (bpm)

    Heart rate

    Measured: peropertively from the laparoscopy trocars introduction until skin closure

  2. Mean arterial pressure (MAP) (mmHg)

    Mean arterial pressure

    Measured: peropertively from the laparoscopy trocars introduction until skin closure

  3. SpO2 (%)

    pulsed oxygen saturation

    Measured: peropertively from the laparoscopy trocars introduction until skin closure

  4. PetCO2 (mmHg)

    End Tidal CO2 pressure

    Measured: peropertively from the laparoscopy trocars introduction until skin closure

  5. Pp (cmH2O)

    Plateau pressure

    Measured: peopertively from the laparoscopy trocars introduction until skin closure

  6. awakening time after disruption/discontinuing analgesia

    time needed for extubation after discontinuing anesthesia maintenance

    Measured: peropertaively

  7. diaphgram mouvement

    diphgram mouvement assessed on the ventilator or in the laparoscopy monitor

    Measured: peropertively

  8. surgeons complaint

    surgeons complaints about operation conditions

    Measured: peropertaively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2018
  2. Study start1 Feb 2015
  3. Primary completion31 Jul 2015
  4. Study completion31 Oct 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03701256
Sponsor's protocol ID
TAP-TRAC
Status last verified
Oct 2018
First submitted
7 Oct 2018
Last updated
17 Oct 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bilateral ultrasound guided TAP bloc and Neuromuscular blockade agent: Atracurium 01mg/kg per bolus in people with Neuromuscular Blockade and Regional Anesthesia, run by University Tunis El Manar at 1 site in Tunisia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Abdominal compliance (Ca) (time frame: peroperatively every 10 minute from the introduction of the laparoscopy trocars until their removal). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018.

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