Comparing the Effects of Levobupivacaine and Bupivacaine in Saddle Spinal Anesthesia
Condition: Outpatients; General Surgery; Anorectal Disorder; Anesthesia; Drug Effect
MeSH terms: Rectal Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      İn this study; it was aimed to investigate the effects of equipotent doses of hyperbaric
      bupivacaine and hyperbaric levobupivacaine in outpatient anorectal surgery under saddle
      block. Sixty patients between the age of 18- 50 and in the risk group of ASA I-II included in
      the study. 7,5 mg of 0,5% hyperbaric bupivacaine or 7,5 mg of 0,5% hyperbaric levobupivacaine
      injected into the intrathecal space in sitting position through L4-L5 or L5-S1 intervertebral
      space in 30 seconds. All patients kept in sitting position for 5 minutes with aid after
      intrathecal injection and than layed in supine position, finally they positioned in prone
      jack-knife. Hemodynamic parameters like NIBP, HR, SpO2, sensory and motor block
      characteristics, duration of analgesia, time of first voiding, mobilization time, patient and
      surgeon satisfaction, adverse effects and discharge time were recorded during and after
      surgery.
    

Detailed 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.
    

Intervention name(s): Levobupivacaine (as Levobupivacaine Hydrochloride) 75 Mg/10 mL Solution for Injection Ampoule; Bupivacaine/Dextrose
Intervention type(s): Drug; Drug
Intervention description(s): 7,5 mg (1.5 mL) of 0,5% hyperbaric levobupivacaine (1 mL 0.75% isobaric levobupivacaine (Chirocaine® 75 mg/10mL ampoule Abbott/Turkey, Nycomed Pharma/Norway) plus 0.24 mL 50% Dextrose (dextrose 120 mg) (Eczacıbaşı/Turkey) and 0.26 mL distilled water) injected into the intrathecal space in sitting position through L4-L5 or L5-S1 intervertebral space in 30 seconds. All patients kept in sitting position for 5 minutes with aid after intrathecal injection and than layed in supine position, finally they positioned in prone jack-knife.; 7,5 mg (1.5 mL) of 0,5% hyperbaric bupivacaine (dextrose content 80 mg/mL) injected into the intrathecal space in sitting position through L4-L5 or L5-S1 intervertebral space in 30 seconds. All patients kept in sitting position for 5 minutes with aid after intrathecal injection and than layed in supine position, finally they positioned in prone jack-knife.
Other intervention name(s): 1 mL 0.75% isobaric levobupivacaine (Chirocaine® 75 mg/10mL ampoule Abbott/Turkey, Nycomed Pharma/Norway) plus 0.24 mL 50% Dextrose (dextrose 120 mg) (Eczacıbaşı/Turkey) and 0.26 mL distilled water.; Marcaine® Spinal Heavy, 0.5%, 4 mL ampoule, AstraZeneca/England, Eczacıbaşı/Turkey, dextrose content 80 mg/mL.
Intervention MeSH terms: Bupivacaine; Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were divided into two groups.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Saddle block; Hyperbaric levobupivacaine and bupivacaine; Outpatient anorectal surgery