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临床试验/CTRI/2025/05/087775
CTRI/2025/05/087775尚未招募不适用

Comparative study of haemodynamic stability in continuous spinal anaesthesia (CSA) vs single dose spinal anaesthesia (SDSA) in lower limb orthopedic surgeries

Shree Krishna Hospital1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2025年6月10日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
64
试验地点
1
主要终点
To Compare the Intra operative haemodynamic stability in Continuous

研究概览

简要总结

After obtaining ethical committee’s approval and written informed consent patients undergoing lower

limb orthopedic surgeries under Continuous Spinal Anaesthesia and Single Dose Spinal Anaesthesia

will be recruited in this study.

Participants will be allotted in to two groups through balanced randomization. A computer software viz.

WINPEPI will be used for the randomization. The procedure allocation will be kept in a sealed opaque

envelops and they will be opened after written informed consent of eligible participants.

Pre-anaesthetic check-up will be carried out in all patients.

Using a sealed envelope technique, patients will be randomly assigned into two

groups

Group C: will receive Continuous Spinal Anaesthesia with Initial dose of 0.5% hyperbaric

BUPIVACAINE 10 mg (2 ml)

Group S: will receive Single Dose Spinal Anaesthesia with Total dose of 0.5% hyperbaric

BUPIVACAINE 18-19 mg (3.6-3.8 ml)

After arrival to procedure room, a peripheral I.V line, a blood pressure cuff and pulse oximetry probe

will be attached.

Pre-operative heart rate, systolic, diastolic, mean arterial pressure, and SpO2 will be recorded.

All patients will be co loaded with Ringer lactate solution 10ml/kg over 15 minutes.

Intraoperative monitoring, including continuous electrocardiogram, pulse oximetry, and Non-invasive

blood pressure, will be attached and baseline vitals noted

Following equipments will be required:

 A portable sterile tray containing:

 Sterile towel and gauze packs

 Sterile gloves

 Spirit

 Bowls containing povidone iodine

 Sterile syringes of 2ml, 5ml and 10 ml

 Sterile needle 18G, 20G and 24G

 Sterile 23G Quincke’s spinal needle

 Epidural catheter set (18 G Epidural Needle, 20 G Epidural Catheter)

 Local anaesthetic agent- Inj Bupivacaine 0.5% (Hyperbaric)

 Local anaesthetic agent- Inj Lignocaine 2 %

Under all aseptic precautions the skin was cleaned with an antiseptic solution.

After palpating a space at or below L3/L4, subcutaneous tissues and muscles are infiltrated with 2 ml of

LIGNOCAINE 2%.

The Tuohy needle (18 G) is then inserted until the resistance of the ligaments is felt. Thereafter the

needle is cautiously advanced, pausing every 0.5 cm to remove the stylet and check for CSF.

Once CSF is identified the needle should be occluded before inserting the catheter 3–4 cm into the

subarachnoid space.

To check the catheter, the end should be lowered below the level of insertion and a constant, steady

drip of CSF is observed. The catheter is then secured using an epidural dressing and the filter is

connected.

 Give 2 ml Hyperbaric Bupivacaine 0.5% (i.e; 10 mg)

with the patient in a supine position and check the block height after 5–10 min.

Further doses of 1 ml Hyperbaric Bupivacaine 0.5% can be injected every 5–10 min until the desired

block height is achieved.

Top up doses of Hyperbaric Bupivacaine 0.5% 0.8 ml can be given every hour to maintain the sensory

at T10.

Sensory and motor level will be evaluated by blind individual every 30 seconds for first 5 minutes, 1

minute till 10 minutes, every 5 minutes till 30 minutes and every 30 minutes till the end of surgery.

Sensory block will be checked bilaterally at mid-clavicular line using pinprick method.

 Intraoperative Hemodynamic Parameters

  1. Mean Arterial Pressure (MAP)- measured every 2 minutes till first 10 minutes, Every 5 minutes

till first 10 minutes followed by every 15 minutes throughout the surgery.

  1. Heart Rate (HR)- measured every 2 minutes till first 10 minutes, Every 5 minutes till first 10

minutes followed by every 15 minutes throughout the surgery.

  1. Systolic Blood Pressure (SBP)- measured every 2 minutes till first 10 minutes, Every 5 minutes

till first 10 minutes followed by every 15 minutes throughout the surgery.

  1. Diastolic Blood Pressure (DBP)-measured every 2 minutes till first 10 minutes, Every 5

minutes till first 10 minutes followed by every 15 minutes throughout the surgery.

  1. Incidence of Hypotension- Decrease in MAP>20% from baseline

  2. Incidence of Bradycardia- Decrease in HR >20% from baseline

  3. Overall Incidence of Hemodynamic Instability- Decrease in MAP and HR >20% from baseline

  4. Use of Vasopressors- Frequency and total dose

  5. Use of Anticholinergics- Frequency and total dose

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing Continuous Spinal Anaesthesia and Single Dose Spinal Anaesthesia for lower limb orthopedic surgery.
  • 18 to 85 years old patients.
  • American Society of Anaesthesiologists Physical Status grade I-V.

排除标准

  • 1.Patients refusing in taking part in the study
  • Allergy to local anaesthetic drug
  • Patients with known bleeding disorders and significantly abnormal coagulation profiles.
  • Local infection at the proposed site of catheter insertion.

结局指标

主要结局

To Compare the Intra operative haemodynamic stability in Continuous

时间窗: 0 minutes, 20 minutes

Spinal Anaesthesia (CSA) vs. Single Dose Spinal Anaesthesia (SDSA) in Lower Limb

时间窗: 0 minutes, 20 minutes

Orthopedic Surgeries.

时间窗: 0 minutes, 20 minutes

次要结局

  • 1.Patients refusing in taking part in the study(2. Allergy to local anaesthetic drug)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Madhavi Chaudhari

Pramukh Swami Medical College,Bhaikaka university

研究点 (1)

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