Comparing two drugs with local anesthetic drug for postoperative epidural analgesia in lower limb orthopedic surgeries

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2021/07/034908
• Lead Sponsor: BLDE deemed to be university

Brief Summary

During the above study period 60 patients posted for lower limb orthopedic surgeries will undergo Spinal anesthesia + Epidural analgesia. Pre-anesthetic evaluation will be done . patients will be shifted to Ot and all standard monitors attached. Patient will be premedicated with Ondansetron 4mg IV. In supine or lateral position 20G portex epidural catheter will be inserted via an 18G Tuohy needle by loss of resistance to air technique and fixed after giving test dose. A 25G spinal needle will  be inserted in l3 l4 interspace and after confirming free flow of csf spinal anesthesia given with bupivacaine. patient monitored intraoperatively . In the post-operative period when patient complains of pain and VAS score is above 5 study drug will be given through epidural catheter

Group A- 2ml 0.5% bupivacaine + 1.5mcg/kg buprenorphine diluted with distilled water upto 10ml

Group B- 2ml bupivacaine + 1mcg/kg fentanyl diluted with distilled water upto 10ml

the patient pulse rate , blood pressure ans vas score will be recorded every 5 minutes for first half hour followed by every hour.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-07-14
• Study Start: 2021-07-20

Recruitment & Eligibility

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

Inclusion Criteria

ASA 1 and 2 only.

Exclusion Criteria

• patient refusal.
• contraindication for epidural .
• pregnant women.
• cardiorespiratory , hepatic, renal , neurological , blood disorders.
• Deformities of spine.
• ASA 3 and 4.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
VAS score less than 5 after administration of epidural drug.	Postoperative every 5minutes til first hour and then hourly for 24hours.

Secondary Outcome Measures

Name	Time	Method
hemodynamic outcomes after drug administration and any adverse effects	postoperatively every 5minutes for first hour and then hourly for 24hours

Trial Locations

Locations (1)

Shri B M Patil Medical College Hospital; 🇮🇳 Bijapur, KARNATAKA, India

Shri B M Patil Medical College Hospital

🇮🇳Bijapur, KARNATAKA, India

Namratha B M

Principal investigator

9945980378

bmnamratha@gmail.com