A CLINICAL TRIAL TO STUDY THE EFFICACY OF TWO BLOCKS FOR LUMBAR DISECTOMY SURGERIES

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2022/01/039249
• Lead Sponsor: IMS BHU

Brief Summary

The study will be conducted in Department of Anaesthesiology, IMS, BHU,Varanasi after obtaining written and informed consent and institutional ethical approval. After CTRI registration,60 patients undergoing lumbar disectomy surgeries, of age 25 to 50 years will be included. Patients will be excluded from study if patient has local infection or significant coagulopathy/bleeding disorders,allergy to Local anaesthetics,psychiatric disorders,history of previous spine surgery and patient refusal. Patient will be divided randomly using computer generated number and concealed using sequentially numbered, sealed opaque envelop technique into two equal groups.

Group (E) will receive USG guided erector spinae block at the level of third lumbar vertebra with 20ml of 0.2% ropivacaine with dexmeditomedine 1mcg/kg on either side.



Group (T) will receive USG guided thoracolumbar interfascial plane block at the level of third lumbar vertebra with 20 ml 0.2% ropivacaine with dexmeditomedine 1mcg/kg on either side.



After 20 minutes,block effect will be checked and those patients for whom block is unsuccessful ,will be excluded from the study.

Then patient will be placed in supine position and anesthesia is induced with propofol 2 mg/kg titrated to effect plus fentanyl 2 μg/kg will be administered for analgesia and muscle relaxation will be achieved with vecuronium 0.1 mg/kg following which oral endotracheal intubation will be done. Anesthesia will be maintained with isoflurane 1MAC and nitrous oxide in 30% oxygen.Inj.Fentanyl 1mcg/kg will be repeated every hourly intraoperatively.



For rescue analgesia in postoperative period,Injection ketorolac 30mg will be given.



In intraoperative period,hemodynamic parameters  (Heart rate,systolic/diastolic/mean blood pressure) will be monitored at minutes 3,5,15,30,60,then hourly,total fentanyl consumption intraoperatively and duration of surgery are noted.



In postoperative period,VAS score will be monitored at 30 minutes,hours 1,6,13,24 (at rest and in motion),time for requirement of first rescue analgesia,total rescue analgesia needed in 24 hours,l and time of mobilisation of patient are noted.



The study will end after mobilisation of patient,after all data has been collected.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-06-01
• Study Start: 2022-10-01

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

ASA grade 1,2 Cases of prolapsed intervertebral disc(PIVD) undergoing disectomy.

Exclusion Criteria

• Patient’s age <25 years and >50 years.
• Patients with Bleeding diasthesis.
• Patient allergic to LA agents.
• Presence of infection at the injection area.
• Patients with H/O previous spine surgeries.
• Refusal of consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual analogue scale	30 minutes,hours 1,6,12,24

Secondary Outcome Measures

Name	Time	Method
Total rescue analgesia requirement in 24 hours	24 hours

Trial Locations

Locations (1)

Trauma centre and superspecialty hospital,IMS,BHU; 🇮🇳 Varanasi, UTTAR PRADESH, India

Trauma centre and superspecialty hospital,IMS,BHU

🇮🇳Varanasi, UTTAR PRADESH, India

Dr Gokulakannan

Principal investigator

8056567635

gokulakannan95@gmail.com