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Comparing the Effects of Levobupivacaine and Bupivacaine in Saddle Spinal Anesthesia

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ClinicalTrials.gov Identifier: NCT04245774
Recruitment Status : Completed
First Posted : January 29, 2020
Last Update Posted : January 29, 2020
Sponsor:
Information provided by (Responsible Party):
Asst. Prof. Hasan Ali KİRAZ, MD, Çanakkale Onsekiz Mart University

Brief 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.

Condition or disease Intervention/treatment Phase
Outpatients General Surgery Anorectal Disorder Anesthesia Drug Effect Drug: Levobupivacaine (as Levobupivacaine Hydrochloride) 75 Mg/10 mL Solution for Injection Ampoule Drug: Bupivacaine/Dextrose Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants were divided into two groups.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: This study was a double blind research.
Primary Purpose: Other
Official Title: Comparing the Effects of Levobupivacaine and Bupivacaine in Anorectal Surgery Under Saddle Spinal Anesthesia
Actual Study Start Date : November 21, 2007
Actual Primary Completion Date : August 13, 2008
Actual Study Completion Date : December 17, 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group L (Hyperbaric Levobupivacaine)

7,5 mg (1.5 mL) of 0,5% hyperbaric levobupivacaine injected into the intrathecal space in sitting position through L4-L5 or L5-S1 intervertebral space in 30 seconds.

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.

Drug: Levobupivacaine (as Levobupivacaine Hydrochloride) 75 Mg/10 mL Solution for Injection Ampoule
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.
Other Name: 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.

Active Comparator: Group B (Hyperbaric Bupivacaine)
7,5 mg (1.5 mL) of 0,5% hyperbaric bupivacaine (Marcaine® Spinal Heavy, 0.5%, 4 mL ampoule, AstraZeneca/England, Eczacıbaşı/Turkey, dextrose content 80 mg/mL) injected into the intrathecal space in sitting position through L4-L5 or L5-S1 intervertebral space in 30 seconds.
Drug: Bupivacaine/Dextrose
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 Name: Marcaine® Spinal Heavy, 0.5%, 4 mL ampoule, AstraZeneca/England, Eczacıbaşı/Turkey, dextrose content 80 mg/mL.




Primary Outcome Measures :
  1. Adequate level of anesthesia for surgery [ Time Frame: The first 20 minutes after administering spinal anesthesia. ]
    The time until the needle tip is not felt in all sacral dermatomes with "pin prick" test at determined time intervals after spinal anesthesia.

  2. Time to obtain maximum sensory block [ Time Frame: Time from administering spinal anesthesia to the end of the surgery (minutes). ]
    The time which the highest level of dermatome is formed when the needle tip is not felt with the "pin prick" test at the specified time intervals.

  3. The highest level of sensory block [ Time Frame: The maximum sensory block level reached until the end of the surgery. ]
    The highest dermatome level where the needle tip is not felt pointed with the "pin prick" test at the specified time intervals.

  4. Two segment regression time of sensory block [ Time Frame: Up to 1 hour. ]
    The time from the maximum sensory block level obtained to two segment regression

  5. The end time of sensory block [ Time Frame: First 24 hours in postoperative period. ]
    The time from sensory block start time until sensory block is removed in all dermatomes assessed by pin prick test.

  6. The degree of maximum motor block [ Time Frame: Up to 1 hour. ]
    With 3 points in modified Bromage score (3= lower extremities cannot be moved).

  7. The time to obtain maximum motor block degree [ Time Frame: Up to 1 hour. ]
    The time until the maximum level of motor block with 3 points in modified Bromage score (3= lower extremities cannot be moved) after spinal anesthesia.

  8. The end time of motor block [ Time Frame: Up to 4 hours. ]
    Time from motor block start time until the modified Bromage score returns to 0 again.


Secondary Outcome Measures :
  1. Heart rate [ Time Frame: From entry time to operating room until postoperative first 24 hours (minutes). ]
    Heart rate as beats/minute

  2. Systolic arterial pressure [ Time Frame: From entry time to operating room until postoperative first 24 hours (minutes). ]
    Non-invasive measurement of systolic arterial pressure (mmHg)

  3. Diastolic arterial pressure [ Time Frame: From entry time to operating room until postoperative first 24 hours (minutes). ]
    Non-invasive measurement of diastolic arterial pressure (mmHg)

  4. Mean arterial pressure [ Time Frame: From entry time to operating room until postoperative first 24 hours (minutes). ]
    Non-invasive measurement of mean arterial pressure (mmHg). To calculate a mean arterial pressure, double the diastolic blood pressure and add the sum to the systolic blood pressure. Then divide by 3.

  5. Peripheral oxygen saturation - SpO2 [ Time Frame: From entry time to operating room until postoperative first 1 hour (minutes). ]
    Non-invasive measurement of SpO2 (%).

  6. First analgesic requirement [ Time Frame: Up to 12 hours. ]
    The time that severity of pain measured using Verbal Numerical Scale (0= no pain, 10= most severe pain possible) above 4 points.

  7. First mobilization time [ Time Frame: Up to 6 hours. ]
    The first time the patient can mobilize in postoperative period

  8. First voiding time [ Time Frame: Up to 12 hours. ]
    The first time the patient can urinate in postoperative period

  9. Patient satisfaction [ Time Frame: Postoperative first 24 hours. ]
    Degree of satisfaction was recorded on a 5-point scale as 0 poor, 1 fair, 2 good, 3 very good and 4 perfect.

  10. Surgeon satisfaction [ Time Frame: Postoperative first 24 hours. ]
    Degree of satisfaction was recorded on a 5-point scale as 0 poor, 1 fair, 2 good, 3 very good and 4 perfect.


Other Outcome Measures:
  1. Perioperative hypotension, bradycardia, nausea, vomiting and respiratory depression [ Time Frame: From entry time to operating room until postoperative first 1 hour (minutes). ]
    Perioperative side effects

  2. Postoperative hypotension, bradycardia, nausea, vomiting, respiratory depression, headache, urinary retention, back pain [ Time Frame: Postoperative first 24 hours. ]
    Postoperative side effects

  3. Number of patients with perioperative ephedrine administered. [ Time Frame: From entry time to operating room until postoperative first 1 hour (minutes). ]
    The mean arterial pressure 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 was administered.

  4. Number of patients with perioperative atropine administered. [ Time Frame: From entry time to operating room until postoperative first 1 hour (minutes). ]
    If heart rate fell below 50 beats/min, it was evaluated as bradycardia and intravenous bolus 0.5 mg atropine was administered.

  5. Number of patients discharged on operation day. [ Time Frame: The day of the surgical operation done. ]
    Number of patients discharged on operation day.

  6. Number of patients discharged on the day after operation. [ Time Frame: One day after the day of the surgical operation done. ]
    Number of patients discharged on the day after operation.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ASA I-II risk group with planned elective anorectal surgery
  • Approved to participate in the study and spinal anesthesia

Exclusion Criteria:

  • Known hypersensitivity to amid-type local anesthetics
  • Not to accept regional anesthesia administration
  • With preoperative motor and sensory loss
  • Not to accept participation in the study
  • Contraindications for spinal anesthesia method

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04245774


Sponsors and Collaborators
Gazi University
Investigators
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Study Director: Cengiz B DEMİREL, 1 Gazi University (formerly)
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Responsible Party: Asst. Prof. Hasan Ali KİRAZ, MD, Assistant professor, MD, Çanakkale Onsekiz Mart University
ClinicalTrials.gov Identifier: NCT04245774    
Other Study ID Numbers: Thesis No: 224639
First Posted: January 29, 2020    Key Record Dates
Last Update Posted: January 29, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Asst. Prof. Hasan Ali KİRAZ, MD, Çanakkale Onsekiz Mart University:
Saddle block
Hyperbaric levobupivacaine and bupivacaine
Outpatient anorectal surgery
Additional relevant MeSH terms:
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Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Bupivacaine
Levobupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents