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临床试验/CTRI/2024/03/064415
CTRI/2024/03/064415尚未招募4 期

A comparative study between 0.75% hyperbaric ropivacaine and 0.5% hyperbaric levobupivacaine for spinal anaesthesia in lower limb orthopaedic surgeries

Dr. Rudranka Basu1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2024年1月4日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
70
试验地点
1
主要终点
Aim- To compare the duration of analgesia between 0.75% hyperbaric ropivacaine and 0.5% hyperbaric levobupivacaine for spinal anaesthesia in patients undergoing lower limb orthopaedic surgeries

研究概览

简要总结

TITLE OF THESIS

A COMPARATIVE STUDY BETWEEN 0.75% HYPERBARIC ROPIVACAINE AND 0.5% HYPERBARIC LEVOBUPIVACAINE FOR SPINAL ANAESTHESIA IN LOWER LIMB ORTHOPAEDIC SURGERIES.

INTRODUCTION

New long-acting local anaesthetics, levobupivacaine and ropivacaine, both being pure left-isomers of bupivacaine and due to their three-dimensional structure seem to have lesser toxic effects on the central nervous system and the cardiovascular system. Through my study I intend to clinically compare the efficacy of 0.75% hyperbaric ropivacaine and 0.5% hyperbaric levobupivacaine in spinal anaesthesia.

AIMS AND OBJECTIVES

AIM:

To compare the duration of analgesia between 0.5% hyperbaric ropivacaine and 0.5% hyperbaric levobupivacaine for spinal anaesthesia in patients undergoing lower limb orthopaedic surgeries.

OBJECTIVES:

PRIMARY:

A)      To compare the onset of sensory block in two drugs.

B)      To compare the onset of motor block in two drugs.

SECONDARY:

A)      To compare the effect of the two drugs on hemodynamic parameters.

B)      To evaluate any adverse effects.

MATERIALS AND METHODS AND DATA COLLECTION PROCEDURE

A total of 70 patients will be randomly divided into two groups of 35 patients each. Group A will receive 15 mg 0.5% (3 ml) hyperbaric levobupivacaine for spinal anaesthesia. Group B will receive 22.5 mg 0.75% (3 ml) hyperbaric ropivacaine for spinal anaesthesia.

Onset and time taken for regression of sensory and motor block will be recorded after every 3 minutes for the first 15 min after injection then every five minutes for the next 25 min and at 60, 90, 120, 180, 240, 300, 360, 420, 480 minutes. Duration of analgesia will be assessed using Numerical Rating Scale Score at 2, 4, 6 and 12 hours in the post-operative period. Heart rate and Blood Pressure will be monitored at 5 minutes interval for first 15 minutes followed by 15 minutes interval till 90 minutes and then at every 30 minutes interval.

|RESULTS AND ANALYSIS

The result will be statistically analyzed using appropriate statistical formula and will be presented using textual, tabular and graphical form.

|CONCLUSION

After detailed discussion of the results and observation of the study, conclusion will be drawn in relation to above mentioned objectives of study.

REFERENCES

1.     H. Blomqvist and A. Nilsson, “Is Glucose-Free Bupiva-caine Isobaric or Hypobaric?†Regional Anesthesia and Pain Medicine, Vol. 14, No. 4, 1989, pp. 195-198.

2.     6 M. P. Vercauteren, H. C. Copp, V. L. Hoffmann, V. Sadien and H. A. Adriaensen, “Small-Dose Hyperbaric versus Plain Bupivacaine during Spinal Anesthesia for Cesarean Section,†Anesthesia & Analgesia, Vol. 86, No. 5, 1998, pp. 989-993.

3.      M. G. Richardson and R. N. Wissler, “Densities of Dextrose-Free İntrathecal Local Anesthetics, Opioids, and Combinations Measured at 37 Degrees C,†Anesthesia & Analgesia, Vol. 84, No. 1, 1997, pp. 95-99

4.      M. G. Richardson and R. N. Wissler, “Densities of Lumbar Cerebrospinal Fluid in Pregnant and Nonpregnant Humans,†Anesthesiology, Vol. 85, No. 2, 1996, pp. 326-330 3. M. G. Richardson and R. N. Wissler, “Densities of Lumbar Cerebrospinal Fluid in Pregnant and Nonpregnant Humans,†Anesthesiology, Vol. 85, No. 2, 1996, pp. 326-330

5.     Stefania Leone, Simone Di Cianni, Andrea Casati†, Guido Fanelli Department of Anesthesia and Pain Therapy, University Hospital of Parma, Parma (Italy), “Pharmacology, toxicology, and clinical use of new long acting local anesthetics, ropivacaine and levobupivacaineâ€

6.     Chung, Chan-Jong MD; Choi, So-Ron MD; Yeo, Kwang-Hwan MD; Park, Han-Suk MD; Lee, Soo-Il MD; Chin, Young-Jhoon MD, “Hyperbaric Spinal Ropivacaine for Cesarean Delivery: A Comparison to Hyperbaric Bupivacaineâ€

7.     Anjani Kumar Singh1, Selvakumar Palaniappan2, K. Selvaraju, “To Evaluate Efficacy and Safety of Isobaric Levobupivacaine Versus Hyperbaric Bupivacaine in Lower Limb Orthopaedic Surgeriesâ€

8.     Gianluca Cappelleri, MD*, Giorgio Aldegheri, MD*, Giorgio Danelli, MD†, Chiara Marchetti, MD*, Massimiliano Nuzzi, MD†, Gabriella Iannandrea, MD†, and Andrea Casati, MD† *Department of Anesthesiology, Vita-Salute University of Milan, IRCCS H. San Raffaele, Milan, Italy; †Department of Anesthesiology, University of Parma, Azienda Ospedaliera di Parma, Parma, Italy, “Spinal Anesthesia with Hyperbaric Levobupivacaine and Ropivacaine for Outpatient Knee Arthroscopy: A Prospective, Randomized, Double-Blind Studyâ€

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing lower limb orthopaedic surgeries under spinal anaesthesia.
  • Age 18-60 years
  • ASA 1 and 2
  • All genders
  • Patients posted for surgeries with expected duration less than 3 hours.

排除标准

  • Patient refusal
  • History of allergic reactions to Local Anaesthetics
  • Coagulopathy
  • History of neurological disorders
  • Patients with spinal deformity
  • Patients with previous spinal surgery.

结局指标

主要结局

Aim- To compare the duration of analgesia between 0.75% hyperbaric ropivacaine and 0.5% hyperbaric levobupivacaine for spinal anaesthesia in patients undergoing lower limb orthopaedic surgeries

时间窗: Onset and time taken for regression of sensory and motor block will be recorded after every 3 minutes for the first 15 minutes after injection then every 5 minutes for the next 25 minutes and at 60, 90, 120, 180, 240, 300, 360, 420, 480 minutes. Duration of analgesia was assessed using Numerical Rating Scale at 2, 4, 6 and 12 hours in the post-operative period.

Objective-

时间窗: Onset and time taken for regression of sensory and motor block will be recorded after every 3 minutes for the first 15 minutes after injection then every 5 minutes for the next 25 minutes and at 60, 90, 120, 180, 240, 300, 360, 420, 480 minutes. Duration of analgesia was assessed using Numerical Rating Scale at 2, 4, 6 and 12 hours in the post-operative period.

1. To compare the onset of sensory block in two drugs.

时间窗: Onset and time taken for regression of sensory and motor block will be recorded after every 3 minutes for the first 15 minutes after injection then every 5 minutes for the next 25 minutes and at 60, 90, 120, 180, 240, 300, 360, 420, 480 minutes. Duration of analgesia was assessed using Numerical Rating Scale at 2, 4, 6 and 12 hours in the post-operative period.

2. To compare the onset of motor block in two drugs.

时间窗: Onset and time taken for regression of sensory and motor block will be recorded after every 3 minutes for the first 15 minutes after injection then every 5 minutes for the next 25 minutes and at 60, 90, 120, 180, 240, 300, 360, 420, 480 minutes. Duration of analgesia was assessed using Numerical Rating Scale at 2, 4, 6 and 12 hours in the post-operative period.

次要结局

  • 1. To compare the effect of the two drugs on hemodynamic parameters.(2. To evaluate any adverse effects.)

研究者

发起方
Dr. Rudranka Basu
申办方类型
Other [self]

研究点 (1)

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