Comparing the Effects of Levobupivacaine and Bupivacaine in Anorectal Surgery Under Saddle Spinal Anesthesia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- The degree of maximum motor block
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This study was a double blind research.
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I-II risk group with planned elective anorectal surgery
- •Approved to participate in the study and spinal anesthesia
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Levobupivacaine (as Levobupivacaine Hydrochloride) 75 Mg/10 mL Solution for Injection Ampoule (Drug)
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.
干预措施: Bupivacaine/Dextrose (Drug)
结局指标
主要结局
The degree of maximum motor block
时间窗: Up to 1 hour.
With 3 points in modified Bromage score (3= lower extremities cannot be moved).
Time to obtain maximum sensory block
时间窗: 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.
Two segment regression time of sensory block
时间窗: Up to 1 hour.
The time from the maximum sensory block level obtained to two segment regression
The end time of sensory block
时间窗: 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.
The time to obtain maximum motor block degree
时间窗: 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.
Adequate level of anesthesia for surgery
时间窗: 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.
The highest level of sensory block
时间窗: 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.
The end time of motor block
时间窗: Up to 4 hours.
Time from motor block start time until the modified Bromage score returns to 0 again.
次要结局
- Peripheral oxygen saturation - SpO2(From entry time to operating room until postoperative first 1 hour (minutes).)
- 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).)
- First analgesic requirement(Up to 12 hours.)
- First mobilization time(Up to 6 hours.)
- First voiding time(Up to 12 hours.)
- Patient satisfaction(Postoperative first 24 hours.)
- Surgeon satisfaction(Postoperative first 24 hours.)
研究者
Asst. Prof. Hasan Ali KİRAZ, MD
Assistant professor, MD
Çanakkale Onsekiz Mart University
