Comparison of efficacy in pain relief ,change in pulse rate, blood pressure and surgeons’ satisfaction between general anaesthesia with local anaesthetic in between lumbar vertebra and erector spine muscle and local anaesthetic injected in spinal space in lumbar spine surgery
- Conditions
- Medical and Surgical,
- Registration Number
- CTRI/2023/07/055014
- Lead Sponsor
- R. G. KAR MEDICAL COLLEGE AND HOSPITAL
- Brief Summary
The study was a randomized single blindedinterventional study and conducted in R.G Kar Medical College and Hospital,Kolkata with the primary objective of comparing the duration of analgesia in between GES (General anesthesia with ESPB)and SA group in terms of first dose of rescue analgesia and, secondaryobjective of observing perioperative hemodynamic changes, intraoperative bloodloss , surgeons’ satisfaction and postoperative nausea, vomiting in between these two groups. Thestudy was done on a total 80 patients divided in two groups( 40 patients in each group) in a spanof one year.
ASA I & II patients and patients not having anymajor co-morbidity were included in the study. They were explained the processwell & valid consent was taken . After all routine investigations, preanesesthetic check up and overnight fasting GES group were administered bilateral USG guided ESPBfollowed by GA and SA group were administered spinal anesthesia in sittingposition.Intra-operative vitals (HR, SBP, DBP,MAP , SPO2) were recorded every 15 minutes interval. VAS score for pain along with haemodynamic parameters wereassessed at 1hr, 2 hr, 4 hr, 6 hr, 12 hr and 24 hr.postoperatively. All the patients were instructed to inform when VASscore for pain > 4 thenrescue analgesia given with IV Tramadolat a dose of 2mg/kg which were repeated every 6 hours until pain score becomes <2. Overthe next 24 hr, PONV was also monitored. If nausea scores were greater than 50, antiemetictherapy with Inj Ondansetron 4 mg IV wasadministered whichwas repeated every 8 hours , if necessary , until vomiting ceased or nauseascores decreased to less than 20. Surgeon’ssatisfaction using 5 point Likert scaleand Blood loss using Boezzart’s scale were recorded after completion of surgery
This study hasshown that GA with ultrasound guided ESPB can provide prolong analgesia andless analgesic requirement in first 24 hourspost operative period in comparison to SA. It also shows us that there wasbetter surgeons’ satisfaction in GES group than SA group. But there is moreblood loss in GES group. Whereas there was no difference in terms ofperioperative hemodynamic changes and PONV.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
- Posted for one or two level lumbar discectomy/laminectomy ( L3 , L4 , L5) 2.
- ASA Grade 1 and 2 patients 3.
- Age between 18-60 years of either sex 4.
- Patients with BMI between 20-30.
- 1.Uncooperative patients or refusal.
- ASA Grade 3 or above 3.
- Duration of surgery more than 2 hours 4.
- Cardiac and neurological diseases.
- Uncontrolled Diabetes and Hypertension.
- Chronic Obstructive Pulmonary Disease and Bronchial Asthma.
- Bleeding disorder 8.
- On psychiatric medication.
- Known allergy to the drug used.
- Alcoholism.
- Chronic opioid use (Defined as daily and almost daily use of opioids for more than 3 months).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Duration of analgesia in both groups in terms of VAS score duration of analgesia is defined as time interval between complete sensory block and time of first rescue analgesia 2)Total analgesic requirement in first 24 hours in both group duration of analgesia is defined as time interval between complete sensory block and time of first rescue analgesia
- Secondary Outcome Measures
Name Time Method Intraoperative surgeons satisfaction in terms of 5point Likert scale It will be assessed immediately after completion of operation , preferably after 2 hours from start of operation
Trial Locations
- Locations (1)
R .G. Kar Medical College And Hospital
🇮🇳Kolkata, WEST BENGAL, India
R .G. Kar Medical College And Hospital🇮🇳Kolkata, WEST BENGAL, IndiaMD AZIZ BILLAHAPrincipal investigator8583841295azizbillaha@gmail.com