STUDY TO COMPARE EFFECT OF BUPIVACAINE AND ROPIVACAINE BOTH WITH FENTANYL IN ULTRA LOW DOSE IN SPINAL ANAESTHESIA (SADDLE BLOCK) IN PATIENTS UNDERGOING ANORECTAL SURGERY.

COMAPARATIVE EVALUATION OF ULTRA LOW DOSE OF BUPIVACAINE AND ROPIVACAINE, BOTH IN COMBINATION WITH FENTANYL IN PATIENTS UNDERGOING ANO-RECTAL SURGERY UNDER SPINAL SADDLE BLOCK AS DAY CARE SURGERY

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/05/053089

Enrollment

160

Registered

2023-05-24

Start date

Unknown

Completion date

Unknown

Last updated

2023-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: Ropivacaine 0.75%: Inj ropivacaine 0.75% , 0.5 ml (3.75 mg) with inj fentanyl 25 mcg given in spinal saddle block Control Intervention1: Bupivacaine 0.5%: Inj bupivacaine 0.5% , 0.5 ml

Eligibility

Inclusion criteria

Inclusion criteria: 1.ASA grade 1 2.ASA grade 2

Exclusion criteria

Exclusion criteria: 1.Patients refusal 2.Patient allergic to study drug 3.Spine deformity 4.Pregnancy 5.ASA grade 3 and 4 6.Focal neurological deficit 7.Inability to understand VAS score 8.Morbid obesity 9.Coagulation disorder 10.Infection at the site of subarachnoid block 11.Preexisting peripheral neuropathy

Design outcomes

Primary

Measure	Time frame
To compare efficacy of ultra low dose of bupivacaine and ropivacaine both with fentanyl in terms of duration of sensory blockadeTimepoint: duration of sensory block will be assessed from time of onset of sensory block at S2 dermatome till regression to S2 dermatome which will be assessed every 2mins till two consecutive readings of sensory block are same and reassessed every 10 minutes till surgery and every 15 minutes postoperatively till regression to S2 dermatome	—

Measure

Time frame

To compare efficacy of ultra low dose of bupivacaine and ropivacaine both with fentanyl in terms of duration of sensory blockadeTimepoint: duration of sensory block will be assessed from time of onset of sensory block at S2 dermatome till regression to S2 dermatome which will be assessed every 2mins till two consecutive readings of sensory block are same and reassessed every 10 minutes till surgery and every 15 minutes postoperatively till regression to S2 dermatome

—

Secondary

Measure	Time frame
1.Onset of sensory block 2.Maximum sensory and motor block 3.Patient satisfaction 4.Surgeon satisfaction 5.Time to first analgesic requirement 6.Adverse events if any Timepoint: 1.Sensory block will be assessed by recording loss to pin prick in perianal ,sacral and lumbar region every 2 minutes till two consecutive readings of sensory block will be same . 2.Maximum sensory and motor blockade will be assessed every 10 min till surgery and every 15 minutes till first analgesic requirement	—

Measure

Time frame

1.Onset of sensory block 2.Maximum sensory and motor block 3.Patient satisfaction 4.Surgeon satisfaction 5.Time to first analgesic requirement 6.Adverse events if any Timepoint: 1.Sensory block will be assessed by recording loss to pin prick in perianal ,sacral and lumbar region every 2 minutes till two consecutive readings of sensory block will be same . 2.Maximum sensory and motor blockade will be assessed every 10 min till surgery and every 15 minutes till first analgesic requirement

—

Countries

India

Contacts

Public ContactRohini Dhote

North DMC medical college and Hindu Rao Hospital

drskgupta4u@gmail.com9810655949

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026