Clinical Trials Logo

Clinical 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)


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03701256
Study type Interventional
Source University Tunis El Manar
Contact
Status Completed
Phase Phase 4
Start date February 1, 2015
Completion date October 31, 2015

See also
  Status Clinical Trial Phase
Recruiting NCT05558969 - The Effect of Magnesium Use in Reversal of Neuromuscular Block With Sugammadex N/A
Completed NCT03168308 - Sugammadex vs. Neostigmine for Neuromuscular Blockade Reversal in Thoracic Surgical Patients Phase 4
Not yet recruiting NCT03978780 - Erector Spinae Block vs. Placebo Block Study N/A
Completed NCT02892045 - Mindray Neuromuscular Transmission Transducer
Completed NCT02912039 - Electromyographic Assessment of the TetraGraph in Normal Volunteers
Completed NCT03427385 - Minimum Local Anesthetic Dose for Adductor Canal Block N/A
Completed NCT01450813 - The Effect of Neuromuscular Blockade on the Composite Variability Index (CVI) During Laryngoscopy N/A
Completed NCT00535496 - Relation Between TOF-Watch® SX and a Peripheral Nerve Stimulator After 4.0 mg.Kg-1 Sugammadex (P05698) Phase 3
Recruiting NCT05794503 - Postoperative Urinary Retention After Reversal of Neuromuscular Block by Neostigmine Versus Sugammadex Early Phase 1
Not yet recruiting NCT05993390 - Pharmacological Reversal of Neuromuscular Blockade in Critically Ill Patients N/A
Recruiting NCT04609410 - Bleeding in Laparoscopic Liver Surgery N/A
Terminated NCT03649672 - The Validity and Tolerability of Awake Calibration of the TOF Watch SX Monitor N/A
Completed NCT05474638 - Comparison of Mechanomyographic 100 Versus 200 Hz 5 Second Tetanic Fade Ratios During Neuromuscular Block Recovery N/A
Completed NCT05687253 - Evaluation of Intubation Conditions Following BX1000 or Rocuronium in Subjects Undergoing Surgery Phase 2
Completed NCT05120999 - Comparison of Onset of Neuromuscular Blockade With Electromyographic and Acceleromyographic Monitoring
Completed NCT03572413 - The Effect of Low Pressure Pneumoperitoneum During Laparoscopic Colorectal Surgery on Innate Immune Homeostasis. Phase 4
Completed NCT03608436 - The Effect of Low Pressure Pneumoperitoneum During Laparoscopic Colorectal Surgery on Early Quality of Recovery Phase 4
Recruiting NCT02930629 - Residual Block in Postoperative Anaesthetic Care Unit N/A
Completed NCT02932254 - Magnesium Sulfate Effect Following the Reversal of Neuromuscular Blockade Induced by Rocuronium With Sugammadex Phase 4
Completed NCT01828385 - Effect of Magnesium on the Recovery Time of Neuromuscular Blockade With Sugammadex Phase 4