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

Neuromuscular Blockade Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03701256
• Other study ID #: TAP-TRAC
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2015
• Est. completion date: October 31, 2015

Study information

• Verified date: October 2018
• Source: University Tunis El Manar
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 31, 2015
• Est. primary completion date: July 31, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• unsuccessful TAP block

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

Related Conditions & MeSH terms

• Neuromuscular Blockade
• Regional Anesthesia

Intervention

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

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

Locations

Country	Name	City	State
Tunisia	Tunis maternity and neonatology center,	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
University Tunis El Manar

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abdominal compliance (Ca)	Ca calculation was based on the formula: Ca= ?V/?P with ?V and ?P referring to the volume variation of CO2 insufflated and ?P to the variation of intraabdominal pressure during the procedure	peroperatively every 10 minute from the introduction of the laparoscopy trocars until their removal
Primary	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	Heart Rate (HR) (bpm)	Heart rate	peropertively from the laparoscopy trocars introduction until skin closure
Secondary	Mean arterial pressure (MAP) (mmHg)	Mean arterial pressure	peropertively from the laparoscopy trocars introduction until skin closure
Secondary	SpO2 (%)	pulsed oxygen saturation	peropertively from the laparoscopy trocars introduction until skin closure
Secondary	PetCO2 (mmHg)	End Tidal CO2 pressure	peropertively from the laparoscopy trocars introduction until skin closure
Secondary	Pp (cmH2O)	Plateau pressure	peopertively from the laparoscopy trocars introduction until skin closure
Secondary	awakening time after disruption/discontinuing analgesia	time needed for extubation after discontinuing anesthesia maintenance	peropertaively
Secondary	diaphgram mouvement	diphgram mouvement assessed on the ventilator or in the laparoscopy monitor	peropertively
Secondary	surgeons complaint	surgeons complaints about operation conditions	peropertaively