A study to compare the clinical features of drugs 0.75% ropivacaine and the combination of ropivacaine 0.75% with fentanyl 25 mcg for spinal anaesthesia in patients undergoing perianal surgeries

Phase 1

Not yet recruiting

• Conditions: Other Procedures,

• Registration Number: CTRI/2024/02/063007
• Lead Sponsor: Dr ARUNKUMAR A BARASAKALE

Brief Summary

Subarachnoid block (SAB) is most widely used regional anesthesia technique in the world. It is a reliable, quick, effective and safe technique with predictable benefits, and has been the procedure of choice for perianal surgeries unless contraindicated.  The changing trend of surgical practice from an inpatient to outpatient has urged us to use short duration acting local anesthetic.

An ideal anesthetic for spinal anesthesia in ambulatory

surgery should provide rapid onset, adequate potency, predictable duration, decreased neurotoxicity along with minimal systemic side effects.The evidence for transient neurological symptoms (TNS) associated with the short-acting spinal anesthetic lidocaine has led to the use of alternative drugs such as bupivacaine, levobupivacaine or ropivacaine. Ropivacaine is the pure S enantiomer of propivacaine and is a amide local anaesthetic which is associated with a lower grade of motor block, a shorter duration of action than bupivacaine and a reduced potential for CNS and cardiac toxicity, making it a possible alternative to lidocaine for shorter outpatient procedures.

The dose of local anesthetic  can be reduced by the addition of adjuvant like opioids and alpha 2 adrenergic agonists.

Subarachnoid fentanyl is known to provide rapid onset of analgesia, improve surgical blockade quality and enhance the effect of small doses of subarachnoid local anaesthetic.

We hypothesise that addition of fentanyl to ropivacaine as neuraxial adjuvant improves the quality of spinal block and prolongs postoperative analgesia without significantly prolonging the time for ambulation without assistance.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2024-02-20
• Study Start: 2024-03-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• a) Patients aged between 18 to 60 years of age posted for elective perianal surgeries.
• b) ASA grade I and II patient.

Exclusion Criteria

• a)Patients who has H/o coagulation and bleeding disorders.
• b) Local site infections.
• c) H/o hypersensitivity to study drugs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.Time taken for ambulation without assistance.	24 hours

Secondary Outcome Measures

Name	Time	Method
1.Time to achieve T10 sensory block	2.Maximum height of sensory block

Trial Locations

Locations (1)

DR.ARUNKUMAR. A. BARASAKALE; 🇮🇳 Bangalore, KARNATAKA, India

DR.ARUNKUMAR. A. BARASAKALE

🇮🇳Bangalore, KARNATAKA, India

DRARUNKUMAR A BARASAKALE

Principal investigator

7204602149

arun.16evez@gmail.com