A study to observe and correlate the depth of needle insertion during spinal anesthesia measured using ultrasound and actual depth of needle insertion
- Conditions
- Measurement and Monitoring,
- Registration Number
- CTRI/2023/05/052966
- Lead Sponsor
- Dr.Thameem Ahamed M
- Brief Summary
After getting approval from the Research committee and Ethics committee of the institute, written informed consent will be obtained from the individuals who are going to undergo surgery under spinal anaesthesia. The study will be done under Department of Anaesthesia, Sri Manakula Vinayagar Medical College and Hospital.The nature of the study will be thoroughly informed to the participants and their attenders and the participants who satisfy the inclusion criteria only will be enrolled strictly.The study will be conducted in the hospital premises after fixing and posted for surgery. Pre operative assessment is done in PAC clinic and re-assessment will be done previous evening before the surgery.The relevant clinical information on BMI, previous surgery histories, airway assessments, history on CVA and MI will been recorded. The participant’s height, weight and BMI will be recorded using calibrated equipment. Procedure - Patient will be kept in NPO for 8 hours - Premedication given T.Alprazolam 0.5mg and T.Pantoprazole 40mg night before the surgery.- Informed written consent will be obtained from each of the participants enrolled. Thedata of the participants will be recorded in the proforma. Details like age, sex, contact information, comorbidities, airway assessment, spine assessment and ASA class will be recorded.On the day of surgery participant will be transferred from ward to OT Patients waiting room. There they will be pre assessed 1 hour before surgery. The patient will be shifted to the OT and necessary monitoring equipment will be attached like non-invasive BP, Pulse oximeter, electrocardiography monitors will be attached and connected. A peripheral I.V line will be secured under SAP.Base line parameters like heart rate, SpO2 and non-invasive blood pressure will be recorded.IV fluids will be connected, after that participant will be made sit in the table and Using ultrasonography measurements will be measured using SONOSITE ultrasound system with 2 – 5 MHz probe curvilinear array transducer will be placed by the observer 2 in a median sagittal plane over the sacrum to visualize the hyperechoic line corresponding to the image of the sacrum. The probe will be moved cephalad in the same plane to visualize the various interspinous spaces till the L3–L4 interspace encountered. A transverse scan will be performed. The L3–L4 interspinous space will be identified by moving the probe slowly cephalad or caudad to obtain the absence of after shadow and the view of the complex formed by the ligamentum flavum-dura mater and to find the vertebral body. The outlines of the various targets will be drawn with a sterile dermographic pen. The optimum sonogram will be taken picture and recorded. With the use of built-in calliper the distance from the skin to the anterior part of the ligamentum flavum-dura mater complex, the bottom limit before reaching intrathecal space, will be measured.For the purpose of study the SSD will be calculated by using Stocker’s formula [SSD (mm) =0.5 × weight (kg) +18] and recordedAfter the successful ultrasonography measurement. The patient will be made to sit in the table by the help of nurse assistants. The lumbar sacral region of the participant will be painted and draped by using povidone iodine and spirit. The l3-l4 space will be palpated by manual palpatory method. After infiltrating the space with 2% LIGNOCAINEsubcutaneously, using a 23G Quincke’s needle a lumbar puncture will be done and the needle will be advanced till the needle placed in sub arachnoid space. After checking the free flow ofcerebrospinal fluid, 0.5% hyperbaric Bupivacaine of required amount pertaining to case will be injected intrathecally at the rate of 0.2ml/second. And then the spinal needle will be withdrawn by marking the point with a sterile marker and depth will be measured using a measuring scale. After that patient will be kept in supine position and continuous vigilant monitoring of the vitals will be done. The level of blockade of sensory and motor blockade will be tested every two minutes till it reaches highest level of level of blockade. Pin-Prick test will be used to assess the sensory blockade and will be scored according to a three-point scale in the dermatomes. Motor Blockade is assessed using Modified Bromage scale.Hemodynamic parameters will be recorded every 10 minutes prior to the procedure and the every 5 mins during procedures for first 30 minutes and every 10 minutes from next hours.Heart rate of less than 50bpm will be managed by administration of injection atropine 0.6mg i.v and hypotension will be considered if mean arterial pressure is less than 20% and if so will be managed by injection EPHEDRINE 6MG iv.Any adverse reactions will be vigilantly seen, noted if any and treated accordingly. INJ.PARACETAMOL 15MG/KG will be used as peri operative analgesia. If there is any adverse events it will be informed to respected ethics committee within 24 hours of occurrence of the event
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 100
- Patients who are willing to give consent 2.
- Age between 18 and 60 years of age 3.
- Participants of either Gender 4.
- ASA grade I or II 5.
- Patients posted for Elective surgeries under Spinal Anaesthesia.
- Participants who are not willing to give consent for spinal anaesthesia 2.
- Absolutely contraindicated conditions for spinal anaesthesia 3.
- Participants with spinal abnormalities will be excluded 4.
- Emergency surgeries.
- Height less than 150cms.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the mean at end of procedure and standard deviation of subarachnoid space depth measured by at end of procedure ultrasonography and depth of needle insertion at end of procedure
- Secondary Outcome Measures
Name Time Method To compare measurements from ultrasound and depth of needle insertion with stocker’s formula.
Trial Locations
- Locations (1)
Sri Manakula vinayagar medical college and hospital
🇮🇳Pondicherry, PONDICHERRY, India
Sri Manakula vinayagar medical college and hospital🇮🇳Pondicherry, PONDICHERRY, IndiaDr Thameem Ahamed MPrincipal investigator09344144044thameemahamed@outlook.com