Assessment of pain relief between erector spinae block and local wound site infiltration in patients undergoing lumbar spinal surgeries
- Conditions
- Medical and Surgical, (2) ICD-10 Condition: O||Medical and Surgical,
- Registration Number
- CTRI/2023/10/059119
- Lead Sponsor
- Rajarajeswari medical college and hospital
- Brief Summary
Spine surgeries are a widely accepted treatment for patients with pathology in the spine. However, postoperative pain following these surgeries is one of the most common complications.In addition, spinal surgery is one of the most painful surgical procedures, creating a major challenge in pain management. This pain begins with an irritation or inflammatory reaction by surgical trauma of the afferent neuron in different back tissues such as ligaments, nerve root sleeves, intervertebral discs, dura, muscles, facet joint capsules and fascia.
**Erector spinae plane (ESP)** block is an interfascial blockade, first described by Forero in 2016. The erector spinae muscle (ESM) is a complex formed by the spinalis, longissimus thoracis, and iliocostalis muscles that run vertically in the back. The ESP block is performed by depositing the local anesthetic (LA) in the fascial plane, deeper than the ESM at the tip of the transverse process of the vertebra and LA is distributed in the cranio-caudal fascial plane one dermatome a median of each 3.4 ml of injected volume.
Aim is to Compare The Efficacy Of Ultrasound Guided Erector spinae block Vs wound infiltration For Post Operative Analgesia In Lumbar spine surgery using levobupivacaine.
Method of collection of data.
After obtaining institutional ethical committee clearance, a comparative study will be carried in Rajarajeshwari Medical college and Hospital in Department of Anaesthesia.
The purpose, the procedure and the risks involved with the study will be explained to the patient and an informed consent will be taken.
50 patients of ASA 1 and ASA 2 aged between 20 and 65 years scheduled for elective single level lumbar discectomy surgeries will be selected. All patients will be subjected to detailed preanesthetic evaluation. Routine and specific investigations will be done as per patients clinical evaluation along with optimising with regular medication if required. Patients will be randomly allocated into two groups of 25 each by single blinded open envelope technique.
Group A – Patients will receive 25 ml of 0.25% Levobupivacaine at the level of L2.
Group B – Patients will receive 25 ml of 0.25% Levobupivacaine over the the surgical wound site.
All the patients will be reviewed and explained about the procedure.
Patients will be kept nil by oral for 6 hours and will be given T.Pantoprazole 40mg T. Alpralozolam.
On arrival of the patient to the operation theatre, monitors will be connected and base line respiratory rate, pulse rate, non-invasive blood pressure, SPO2 and ECG recorded. Intravenous line of 18G shall be secured and intravenous fluids will be started as per requirement.
Patient in supine position with adequate preoxygenation and premedication with Inj Midazolam 0.01mg/kg and Inj Glycopyrolate 0.2mg will be induced with Inj Fentanyl 1-2mcg/kg, Inj Propofol 2mg/kg and Inj. Vecuronium 0.1mg/kg.
After obtaining adequate muscle relaxation, laryngoscopy will be done and intubated with endotracheal tube. Bilateral airway entry is confirmed and secured appropriately.
Patient is changed to prone position and hemodynamic parameters will be monitored throughout the procedure at regular intervals.
At the end of surgery, under strict aseptic conditions, counting above from L4 vertebrae from the tuffiers line , L3 vertebrae will be identified. A curvilinear USG probe will be placed across the L2 spine and probe will be moved to identify L2 lateral process.
20 ml of 0.25% levobupivacaine is injected below the fascia of erector spinae level using 23G Quincke needle by out of plane technique. Before this 2-3 ml of NS will be injected to make out the spread. In the other group, local wound site infiltration is done using 20 ml of 0.25% levobupivacaine.
The patient is changed to supine position and extubation will be done after a reversal of residual neuromuscular block with neostigmine (0.05 mg/kg) and glycopyrrolate (0.01 mg/kg) at the end of the surgery. Patients will be transferred to post anesthesia care unit to monitor hemodynamic parameters, postoperative pain, sedation, nausea and vomiting at 0,1,2,4,6,8,12,16,20,24hrs. Patients will be evaluated pain postoperatively for the duration of analgesia and pain will be assessed using a standard 10 cm linear VAS.
Pain assessment will be done 20 minutes after extubation which will be considered as zero time.
Total duration of analgesia will be taken from zero time till the first rescue analgesic requirement.
When VAS score is more than or equal to 4, Inj.Paracetamol 1g will be given as rescue analgesia. Total number of doses of Inj Paracetamol 1g given in 24 hours will be noted.
Patients will be left out of the study in case of block failures
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 50
- ASA grade 1 and 2 patients.
- Patients aged 20-65 yrs undergoing single level lumbar discectomy surgeries.
Patient refusal Patients with known hypersensitivity to local anaesthetics Patient with bleeding disorder, uncontrolled Diabetes Mellitus, severe Renal & Liver Diseases Patient with Epilepsy Mentally unstable patients.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare & assess the analgesic efficacy postoperatively between Erector spinae block & local wound site infiltration. To compare & assess the analgesic efficacy postoperatively between Erector spinae block & local wound site infiltration in FIRST 24 hrs.
- Secondary Outcome Measures
Name Time Method To compare the need of rescue analgesia postoperatively between Erector spinae block & local wound site infiltration Comparison of hemodynamic parameters. complications if any
Trial Locations
- Locations (1)
Rajarajeswari medical college and hospital
🇮🇳Bangalore, KARNATAKA, India
Rajarajeswari medical college and hospital🇮🇳Bangalore, KARNATAKA, IndiaDr Karthik G SPrincipal investigator9538220515drgskarthik@gmail.com