Effectiveness of Hyaluronidase as an Adjuvant to Bupivacaine in Ultrasound Guided Supraclavicular Brachial Plexus Block for Upper Limb Surgery
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Onset of complete motor block
研究概览
简要总结
Background Brachial plexus block is a good choice for surgeries of the upper limb because it provides good quality of anesthesia and analgesia especially in patients with multiple comorbidities and in ambulatory surgery. Hyalaluronidase is a local anesthetic adjuvant used for ophthalmologic surgery. We evaluated the effect of adding hyaluronidase to bupivacaine as regard the onset and duration of motor and sensory block in ultrasound guided supraclavicular brachial plexus block.
Methodology prospective, randomized and double-blind study conducted at Sohag University Hospital. A total of 40 adults scheduled for upper limb surgery, ASA I or II were randomly assigned into two groups (n=20). Group I received bupivacaine 0.375 % 15 mL + normal saline 4ml +hyaluronidase 800 IUin 1 ml. Group II received bupivacaine 0.375% 15 mL + normal saline5 ml. Both groups will be compared for onset and duration of sensory and motor block, duration of analgesia and complications.
Results The onset of sensory and motor block was significantly faster in hyaluronidase group than control group. Significant difference could not be detected in either duration of the sensory or motor block between the two groups.
Conclusion The use of hyaluronidase as an additive to bupivacaine fastens the onset of sensory and motor block of the brachial plexus in supraclavicular approach without affecting the duration of the block.
详细描述
This prospective, randomized, controlled and double-blind study was conducted at Sohag University Hospital after approval from institution review board and obtaining written informed consents from all participants. Forty participants, aged 18 to 60 years, American Society of Anesthesiologists class I and II, scheduled for elective surgery of the upper extremities were included in this study. Participants who refuse or have allergy to local anesthetic or hyaluronidase or suffering from severe renal, hepatic, pulmonary, cardiac, neurologic, psychiatric or neuromuscular disease will be excluded from the study in addition to pregnant or lactating women, patients with morbid obesity, coagulation disorders as well.
Sealed envelopes technique was used to randomly assign patients to both study groups; Group I; received bupivacaine 0.375 % 15 mL + normal saline 4ml +hyaluronidase 800 IU in 1 ml.
Group II; received bupivacaine 0.375% 15 mL + normal saline5 ml. After arriving to the operative theater basic monitoring was applied and intravenous line was inserted. Midazolam 2mg and Fentanyl 50 mcg was administered intravenously to all participants 15 minutes before the procedure. Anesthesiologist who carried out the block and recorded the study measurements was blinded to the treatment groups.
The participants were in supine position with the head rotated to the opposite side and neck extended, 7 to 12 MHz linear ultrasound probe (SonoScape A5, SonoScape Co., Ltd., China) was placed above the clavicle to identify distal trunks or proximal divisions of the brachial plexus lateral and cephalad to the subclavian artery above the first rib. After ultrasound pre-scan and local infiltration with 3ml lidocaine 2%, 100 mm, 20 gauge nerve-stimulating needle (Locoplex®, VYGON, FRANCE) was inserted under real time ultrasound guided technique in line approach and advanced until reaching the brachial plexus sheath the needle was repositioned to allow local anesthetic spread around all trunks or divisions. Injection was stopped if an increased resistance to injection experienced or parathesia to avoid intra neural injection. All participants were transferred to post-anesthesia care unit postoperatively to be observed for the following measurements:
The primary measurement:
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 18 to 60 years
- •American Society of Anesthesiologists class I and II
- •Scheduled for elective surgery of the upper extremities
排除标准
- •allergy to local anesthetic or hyaluronidase
- •Severe renal or hepatic disease
- •Pulmonary, cardiac disease
- •Neurologic, psychiatric disease
- •Neuromuscular disease
- •Pregnant or lactating women
- •Morbid obesity
- •Coagulation disorders as well
研究组 & 干预措施
Group I
received bupivacaine 0.375 % 15 mL + normal saline 4ml +hyaluronidase 800 IU in 1 ml.
干预措施: Hyaluronidase (Drug)
结局指标
主要结局
Onset of complete motor block
时间窗: during the first 24 hours
time from injection to complete motor block
Onset of complete sensory block
时间窗: during the first 24 hours
time from injection to complete sensory block to pin prick
次要结局
- duration of motor block(during the first 24 hours)
- duration of anlgesia(during the first 24 hours)
- side effects(during the first 24 hours)
- Duration of sensory block(during the first 24 hours)
研究者
Hitham Mohammed Aly Elsayed
lecturer of anesthesia and surgical ICU
Sohag University