Comparing the Effects of Levobupivacaine and Bupivacaine in Saddle Spinal Anesthesia

NCT04245774 | Completed Phase 4 DMC

• 1 other identifier: Thesis No: 224639
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Outpatients; General Surgery; Anorectal Disorder; Anesthesia; Drug Effect

Keywords

Saddle block; Hyperbaric levobupivacaine and bupivacaine; Outpatient anorectal surgery

Outcome Measures

Primary Outcomes (8)

• Adequate level of anesthesia for surgery

  The time until the needle tip is not felt in all sacral dermatomes with "pin prick" test at determined time intervals after spinal anesthesia.

  The first 20 minutes after administering spinal anesthesia.

• Time to obtain maximum sensory block

  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.

  Time from administering spinal anesthesia to the end of the surgery (minutes).

• The highest level of sensory block

  The highest dermatome level where the needle tip is not felt pointed with the "pin prick" test at the specified time intervals.

  The maximum sensory block level reached until the end of the surgery.

• Two segment regression time of sensory block

  The time from the maximum sensory block level obtained to two segment regression

  Up to 1 hour.

• The end time of sensory block

  The time from sensory block start time until sensory block is removed in all dermatomes assessed by pin prick test.

  First 24 hours in postoperative period.

• The degree of maximum motor block

  With 3 points in modified Bromage score (3= lower extremities cannot be moved).

  Up to 1 hour.

• The time to obtain maximum motor block degree

  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.

  Up to 1 hour.

• The end time of motor block

  Time from motor block start time until the modified Bromage score returns to 0 again.

  Up to 4 hours.

Secondary Outcomes (10)

• Heart rate

  From entry time to operating room until postoperative first 24 hours (minutes).

• Systolic arterial pressure

  From entry time to operating room until postoperative first 24 hours (minutes).

• Diastolic arterial pressure

  From entry time to operating room until postoperative first 24 hours (minutes).

• Mean arterial pressure

  From entry time to operating room until postoperative first 24 hours (minutes).

• Peripheral oxygen saturation - SpO2

  From entry time to operating room until postoperative first 1 hour (minutes).

Other Outcomes (6)

• Perioperative hypotension, bradycardia, nausea, vomiting and respiratory depression

  From entry time to operating room until postoperative first 1 hour (minutes).

• Postoperative hypotension, bradycardia, nausea, vomiting, respiratory depression, headache, urinary retention, back pain

  Postoperative first 24 hours.

• Number of patients with perioperative ephedrine administered.

  From entry time to operating room until postoperative first 1 hour (minutes).

Study Arms (2)

Group L (Hyperbaric Levobupivacaine)

EXPERIMENTAL

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

Group B (Hyperbaric Bupivacaine)

ACTIVE COMPARATOR

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

Interventions

Levobupivacaine (as Levobupivacaine Hydrochloride) 75 Mg/10 mL Solution for Injection Ampoule DRUG

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.

Also known as: 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.

Group L (Hyperbaric Levobupivacaine)

Bupivacaine/Dextrose DRUG

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.

Also known as: Marcaine® Spinal Heavy, 0.5%, 4 mL ampoule, AstraZeneca/England, Eczacıbaşı/Turkey, dextrose content 80 mg/mL.

Group B (Hyperbaric Bupivacaine)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gazi University: lead

MeSH Terms

Conditions

Rectal Diseases

Interventions

Levobupivacaine; Solutions; Glucose; Bupivacaine

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pharmaceutical Preparations; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Cengiz B DEMİREL, 1

  Gazi University (formerly)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study was a double blind research.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor, MD

Model Details: Participants were divided into two groups.

Study Record Dates

• First Submitted: January 20, 2020
• First Posted: January 29, 2020
• Study Start: November 21, 2007
• Primary Completion: August 13, 2008
• Study Completion: December 17, 2008
• Last Updated: January 29, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share