Hernia, Inguinal Clinical Trial
Official title:
Intrathecal 60mg Prilocaine, Hyperbaric 40mg 9-chloroprocaine and 10.5mg Bupivacaine Each With Added Sufentanil (2µg) for Elective Ambulatory Umbilical and Unilateral Inguinal Herniorrhaphy
Considering fast-track principles, an ideal spinal anesthetic should have minimal
complications and above all fast recovery so reducing in-hospital stay.
Between 1/8/2015 and 1/1/2016, a total of 101 patients attending the surgeon's practice with
an umbilical or unilateral inguinal hernia and no contra-indications for surgery were
included in this study. Patients were given 10.5mg bupivacaine (B-group), 40mg hyperbaric
2-chloroprocaïne (C-group) or 60mg prilocaïne (P-group), each with added sufentanil (2µg).
Motor block was assessed using the Bromage scale. Sensory block was measured by determining
the peak level dermatome. Intraoperative hemodynamic parameters were listed. Resolution of
sensory and motor block, time to void and home readiness were defined as clinical endpoints.
Open inguinal and umbilical hernia repair are two of the most performed interventions in
day-care surgery. Fast-track surgery implies a swift and effective form of anesthesia which
is easy to carry out, has few side-effects and is quickly reversed.
Spinal anesthesia has proven to be a safe method to ensure adequate analgesia for patients
undergoing elective open abdominal wall surgery as the need and side-effects of general
anesthesia are avoided. During many years, a variety of intrathecal products alongside a
plethora of adjuvants have been evaluated.
Three different types of spinal anesthetic products already used in routine care were
compared: hyperbaric 9-chloroprocaïne (Ampres®, Nordic Pharma), bupivacaine (Marcaine®,
AstraZeneca) and prilocaine (Tachipri®, Nordic Pharma).
Between 1/8/2015 and 1/1/2016, a total of 101 patients attending the surgeon's practice with
an umbilical or unilateral inguinal hernia and no contra-indications for surgery were
included in this study. Local ethical committee approval (EC0G099 - AZ Sint Dimpna, Geel,
Belgium) and individual written informed consent was obtained. Surgical procedures were
performed by 2 surgeons (TL and TG). The hernia was diagnosed clinically and/or by
ultrasonography. Patients were preoperatively informed about the details concerning surgery
and anesthesiology.
All patients were hospitalized on the day of surgery following standard preoperative
instructions. Spinal anesthesia was performed by 6 different anesthesiologists. Patients
with contraindications for spinal anesthesia were excluded: INR (international normalized
ratio) > 1.2, thrombocytopenia (<75.000/µl), symptomatic neurological disease and proven
allergy for local anesthetic. All patients received 1g of cefazolin (following standard
guidelines for antibiotic prophylaxis of surgical wounds).
Patient's baseline features were listed: gender, age, Body Mass Index (BMI),
Anesthesiologists Physical Status classification (ASA classification), their position at the
moment of intrathecal infusion (sitting up or lateral decubitus) and type and length of
surgery. Open inguinal herniorrhaphy was performed following the Liechtenstein technique as
described by Chastan. For the treatment of an umbilical hernia, a polypropylene-ePTFE hernia
patch (Ventralex™, BARD®) was used .
Patients were given 10.5mg bupivacaine (B-group), 40.0mg of hyperbaric 2-chloroprocaïne
(C-group) or 60.0mg prilocaïne (P-group), each in combination with sufentanil (2.0µg).
All patients with pre-existing hypotension (<120/80) were administered 5.0mg of ephedrine
and 0.2mg of glycopyrroniumbromide IV upon entering the operation theater through a standard
peripheral catheter. Regular monitoring was used during the procedure: electronic blood
pressure monitoring, pulse oximetry and 3-lead electrocardiogram. Hemodynamic anomalies were
listed: hypotension (systolic pressure <75% of baseline value), bradycardia (pulse <60/min)
and desaturation (<92% without oxygen).
Under sterile conditions, local anesthesia of the skin of the lower back was performed
(using 1% 3cc lidocaine). Afterwards, puncture of the arachnoid mater (using a 25G Sprottle
Needle) was performed at the L2-L3 interspace and the predetermined product instilled. This
procedure was performed sitting-up or in dorsolateral decubitus (in inguinal hernia repair
lying on the ipsilateral side when using prilocaine or bupivacaine and on the contralateral
side when using hyperbaric 2-chloroprocaine). Patients who received their spinal block in
the sitting up position were instantly put in the dorsolateral position after the injection
(side again depending on the product and type of surgery as described above). Regardless of
these proceedings, all patients receiving 9-chloroprocaine were put in the reverse
Trendelenburg position (approximately 20°) for 2 minutes immediately after infusion.
After injection, sensory and motor block assessment was performed and listed on
predetermined moments: 1, 3, 30 minutes after infusion and from then on every 15 minutes
until spontaneous voiding (>200ml) was achieved. Sensory block was evaluated from toe to
head at the surgical side using the loss of sensation to cold fluids (ether). Motor block
was assessed using the Bromage scale.
During surgery, hypotension (systolic pressure <75% of baseline value) was treated with
ephedrine and bradycardia with atropine or ephedrine. Patients who suffered from
desaturation (blood oxygen saturation <92%) received oxygen through a standard face mask
starting at 2l/min. Fentanyl 25 to 100µg was given when pain was felt by the patient. If
insufficient analgesia was achieved (insufficient sensory block), general anesthesia was
initiated. Intraoperative IV analgesia consisted of standard postoperative pain medication
(taradyl and perfusalgan). If there was a history of duodenal ulcus, kidney insufficiency
and/or intolerance for NSAIDs, taradyl was replaced with dynastat.
Postoperatively, all patients were transferred to the Post-Anesthesia Care Unit (PACU),
where they received standard postoperative analgesia (paracetamol 1g IV and/or taradyl 30mg
IV). If insufficient, fentanyl was administered. Postoperative nausea and vomiting (PONV)
was treated with alizapride and ondansetron. After a minimum stay of 90 minutes, signs of
regression of the motor block (Bromage scale) and normal hemodynamic parameters, patients
were transferred to the day-care hospital for further recovery.
Resolution of sensory and motor blockage, time to void and home readiness (spontaneous
voiding, ability to walk without assistance, the absence of nausea or vomiting and stable
hemodynamic parameters) were defined as clinical endpoints. Pain experienced at the day-care
hospital was managed with oral paracetamol (500mg) and/or ibuprofen (600mg), after
determination of a Visual Analog Scale for Pain (VAS).
All data was analyzed using IBM SPSS statistical software version 23 and Microsoft Excel
2010. Comparison of continuous variables was performed using the F-test and posthoc analysis
. Categorical variables were compared by means of a chi-square test. A P-value < 0.05 was
considered statistically significant.
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