Comparing the Effects of Levobupivacaine and Bupivacaine in Anorectal Surgery Under Saddle Spinal Anesthesia
Description:
This study was completed in the General Surgery operating room within the Department of
Anesthesiology and Reanimation in Gazi University Faculty of Medicine after receiving
permission from Gazi University, Faculty of Medicine Local Ethics Committee (dated
28.05.2007, numbered 172). After receiving informed consent forms, the study included 60
patients aged 18-50 years in ASA I-II risk group with planned elective anorectal surgery.
Those with known hypersensitivity to amid-type local anesthetics, who did not accept regional
anesthesia administration, with preoperative motor and sensory loss, who did not accept
participation in the study and with contraindications for spinal anesthesia method were not
included in the study.
Patients did not have premedication before the operation. Patients were divided into two
groups with Group B given 7.5 mg (1.5 mL) hyperbaric bupivacaine (Marcaine® Spinal Heavy,
0.5%, 4 mL ampoule, AstraZeneca/England, Eczacıbaşı/Turkey, dextrose content 80 mg/mL), while
Group L were administered 7.5 mg (1.5 mL) hyperbaric levobupivacaine. In order to obtain
hyperbaric levobupivacaine, 1 mL 0.75% isobaric levobupivacaine (Chirocaine® 75 mg/10mL
ampoule Abbott/Turkey, Nycomed Pharma/Norway) was added to 0.24 mL 50% Dextrose (dextrose 120
mg) (Eczacıbaşı/Turkey) and 0.26 mL distilled water. While mixing hyperbaric levobupivacaine,
in order to obtain accurate doses of levobupivacaine, it was measured with 50% dextrose and 1
mL distilled water in an insulin injector. The hyperbaric bupivacaine and hyperbaric
levobupivacaine had specific gravity values measured in Gazi University, Central Biochemistry
Laboratory (solutions were heated before measurements and set with an electronic thermometer
– Microlife gold-tipped thermometer MT 3001, importer Trimpeks – İstanbul, Made in P.R.C.) at
37 ºC as 1.026 (URISYS 2400, Serial No:1744-017 part No:614-0010, Roche Diagnostics Germany,
Made in Japan Production year 2005). Based on specific gravity, mean density in water at 37
ºC was accepted as 0.993 g/mL (51,72) and we calculated the solution density used in our
study as 1.0188 g/mL (1.026 x 0.993 g/mL = 1.0188 g/mL).
Local anesthetics to be used for spinal anesthesia were prepared by another anesthesiologist
so the researcher who would administer and monitor the patient, and the patient, did not know
which was used. Sixty patients had the random double-blind study method applied according to
order until each group contained 30 patients. Before administering spinal anesthesia, IV
cannulation was performed on the nondominant hand with an 18-gauge (G) branule and patients
were administered 8-10 mL/kg Ringer lactate solution over 10-15 minutes. The fluid amounts
before anesthesia and in total were recorded. Patients taken to the operating room had ECG
(II derivation), SpO2, and noninvasive blood pressure (NIBP) monitoring performed (NIHON
KOHDEN, Model: BSM4113K, SN:01236, 2004 – Japan). The 4 L/min O2began to be administered
through a mask and basal hemodynamic parameters for patients with preoperative motor and
sensory examination were recorded as control values on the monitoring form prepared for the
study.
All patients had spinal anesthesia performed in the sitting position in the L4-5 or L5-S1
interspinous space. The number of spinal puncture attempts and the successful interval were
recorded. If puncture was unsuccessful on the third attempt, the case was excluded from the
study. All drugs were prepared for single use under sterile conditions.
After necessary skin disinfection, the interval for the intervention had local anesthesia
provided by 2 mL 2% lidocaine administered with a 22 G fine needle to infiltrate the
ligamentum flavum from the skin. The appropriate interval first had a 20 G 35 mm needle
introducer (guide needle) inserted from the spinal needle set. Within the introducer, a 26 G
atraumatic spinal needle (Atraucan®, B.Braun, Melsungen AG) was inserted parallel to the dura
fibers on the midline until the dura was passed and then the chuck of the spinal needle was
removed and after clear cerebrospinal fluid (CSF) was observed the needle opening was turned
toward sacral. For Group B 7.5 mg hyperbaric bupivacaine (1.5 mL) and for Group L 7.5 mg (1.5
mL) hyperbaric levobupivacaine was administered into the intrathecal space over 30 seconds
and the end of drug administration was accepted as 0 minutes. Supported by an assistant, the
patients were left in sitting position for 5 min and then laid supine. The break region of
the operating table was placed equivalent to the iliac crista of the patient and they were
given the prone jack-knife position.
Spinal anesthesia sensory block level, motor block degree and hemodynamic markers of heart
rate (HR), systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial
pressure (MAP) and SpO2values were recorded every 2.5 min until 15 min after spinal
anesthesia and later every 5 min until the end of surgery. Sensory block level was assessed
using a blunt-tipped needle with the ‘pin prick’ test by touching appropriate dermatome on
the standard dermatome map; sympathetic block degree was measured with the feeling of
temperature on the skin by touching with cold alcohol sponge; and motor block level was
assessed with the modified Bromage scale (0= no paralysis, thighs, legs and feet can be
raised, 1= thighs cannot be moved, knees moved, 2= knees cannot be moved, ankles can be
moved, 3= lower extremities cannot be moved). After identifying that all sacral dermatome
could not feel the tip of the needle, the operation was allowed to begin. The duration from
puncture to beginning of operation was recorded. With the ‘pin prick’ test, the region of
surgery was checked for sufficient sensory block for analgesia. Sensory block was recorded
and evaluated as the duration sensory block continued before regression to two dermatome.
Sensory and motor block assessments were performed during the operation. The duration to form
sufficient anesthesia for the relevant surgery, time when maximum levels were reached,
maximum level, time for sensory block to regress two segments and end time for sensory block
were recorded. For motor block, maximum motor block degree and formation duration, and end
time for motor block were assessed and recorded. If sufficient anesthesia was not provided 20
min after administration of spinal anesthesia, the case was excluded from the study and
general anesthesia was planned. MAP falling more than 20% according to control values or
below 60 mmHg was accepted as hypotension, and rapid fluid replacement began (50 mL/min). If
there was no response within three minutes, IV bolus 5 mg ephedrine (Ephedrine HCl ampoule,
0.05 g, 1 mL OSEL/İstanbul) was administered and total ephedrine amounts before being sent to
the ward were recorded. If HR fell below 50 beats/min, it was evaluated as bradycardia and IV
bolus 0.5 mg atropine (atropine sulfate, ½ mg, 1 mL ampoule, OSEL/İstanbul) was administered
and it was recorded on the monitoring form.
Patients were monitored for side effects like hypotension, bradycardia, nausea, vomiting,
pain, shivering, discomfort and respiratory depression during the operation and complications
were recorded. At the end of surgery, total surgical duration was recorded and patient and
surgical team were asked whether they were satisfied with the anesthesia method. Degree of
satisfaction was recorded on a 5-point scale as 0 poor, 1 mediocre, 2 good, 3 very good and 4
perfect.
At the end of the surgical intervention, cases were placed in supine horizontal position and
taken to the recovery room. In the recovery room, patients had the verbal numerical scale
(VNS) explained (0= no pain, 10= most severe pain possible) and severity of pain was
recorded. Patients with VNS scores above 4 were administered pethidine (Aldolan® ampoule,
Pethidine HCl 100 mg/2mL Liba/İstanbul, Gerot Pharmazeutika/Austria) IM 1 mg/kg. The time for
first analgesic requirements was recorded (total analgesia duration). In the first hour in
the recovery room, HR, SAP, DAP, MAP, SPO2, sensory block and motor block levels were
recorded every 10 minutes. Patients with normal parameters in the recovery room were sent to
the general surgery ward. SAP, DAP, MAP, sensory block levels, motor block degree and side
effects were recorded on the patient monitoring form prepared for the study in the ward every
30 min from the 90th minute to 3 hours and every hour from 3rd to 6th hours and at the 8th,
10th, 16th and 24th hours. Patients were requested to report their time of first urination
and time of first walking on the ward. Patients without pain during postoperative monitoring
in the recovery room were requested to note the time for first analgesic requirements (total
analgesia duration) and wards were visited to record this information. Patients were
monitored in terms of complications like headache, back ache, urinary retention, pain in
legs, weakness, urinary or anal incontinence, nausea, vomiting, hypotension, and bradycardia
from after the operation until discharge. Discharge day was recorded. After discharge, they
were told to inform the researchers of any problems and were telephoned and monitored for
headache and temporary neurologic symptoms.
Condition:
Outpatients
Treatment:
Levobupivacaine (as Levobupivacaine Hydrochloride) 75 Mg/10 mL Solution for Injection Ampoule
Start Date:
November 21, 2007
Sponsor:
Gazi University
For More Information:
https://clinicaltrials.gov/show/NCT04245774