Bilateral Transversus Abdominis Plane Block Versus Atracurium During Laparoscopic Gynecology Procedures.
Condition: Neuromuscular Blockade; Regional Anesthesia
Study type: Interventional
Phase: Phase 4

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)
    

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.
    

Intervention name(s): Bilateral ultrasound guided TAP bloc; Neuromuscular blockade agent: Atracurium 01mg/kg per bolus
Intervention type(s): Procedure; Drug
Intervention description(s): In the TAP group: Bilateral ultrasound guided TAP bloc for laparoscopic gynecologic surgery; In the TRAC group: Neuromuscular blockade agent: Atracurium 01mg/kg per bolus for maintaining muscular relaxation and immobilization during laparoscopic gynecologic surgery
Intervention MeSH terms: Atracurium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: TAP block; curare; laparoscopy; gynecology surgery; abdominal compliance