Spinal Anesthesia

Study of Functional Recovery after Chloroprocaine and Bupivacaine in Spinal Anaesthesia

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/11/022014

Enrollment

Registered

2019-11-15

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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

Conditions

Health Condition 1: - Health Condition 2: N433- Hydrocele, unspecified

Interventions

Intervention1: Chloroprocaine: Injection 1% Chloroprocaine, 4ml given in subarachnoid space Control Intervention1: Bupivacaine: Injection 0.25% Bupivacaine, 4ml given in subarachnoid space

Eligibility

Inclusion criteria

Inclusion criteria: ASA Grade 1 and 2 of either sex Age between 18-60 years Lower abdominal, pelvic, perineal and lower limb surgeries Patients planned for surgery not more than 1 hour

Exclusion criteria

Exclusion criteria: 1.Patients with active mental dysfunction or cognitive deficiency 2.History of psychiatric illness. 3.Patients with neuro-muscular, vestibular, hepatic or major systemic disease. 4.History of alcohol or drug abuse. 5.History of allergy to local anaesthetic. 6.Patients with any contraindication to spinal anaesthesia 7. Morbid obesity. 8. Medical conditions affecting balance and coordination.

Design outcomes

Primary

Measure	Time frame
Intraoperative assessment- Time to achieve height of block at T10,T5,to reach the MBS Grade 3,to sensory regression to L1 level SLR test,Deep knee bend,Heel-shin touch,Joint position +ve or - ve,Grade of MBS at 1,2,4 hr Postoperative Assessment- SLR Test 30,60,90 degree,Deep knee bend,Heel-shin touch,Joint position,Time to MBS Grade 0,Time to Romberg test negative,assisted ambulation,complete ambulation,void urine Duration of analgesia Timepoint: Intraoperative sensory-motor assessment will be done at 5, 10, 30, 40, 50, 60 minutes. Postoperative clinical assessment will be done at 1st, 2nd, 3rd, 4th, 4.5th, 5th hour.	—

Measure

Time frame

Intraoperative assessment- Time to achieve height of block at T10,T5,to reach the MBS Grade 3,to sensory regression to L1 level SLR test,Deep knee bend,Heel-shin touch,Joint position +ve or - ve,Grade of MBS at 1,2,4 hr Postoperative Assessment- SLR Test 30,60,90 degree,Deep knee bend,Heel-shin touch,Joint position,Time to MBS Grade 0,Time to Romberg test negative,assisted ambulation,complete ambulation,void urine Duration of analgesia Timepoint: Intraoperative sensory-motor assessment will be done at 5, 10, 30, 40, 50, 60 minutes. Postoperative clinical assessment will be done at 1st, 2nd, 3rd, 4th, 4.5th, 5th hour.

—

Secondary

Measure	Time frame
To assess other sequential motor recovery process including recovery parameters of home readiness till ability to pass urine and to note any side effects eg nausea,vomiting,headache,hypotension,bradycardia and prolonged motor block which could delay the dischargeTimepoint: Time since spinal anaesthesia given to 5 hours	—

Countries

India

Contacts

Public ContactManoj Kumar

Jawaharlal Nehru Medical College, AMU, Aligarh

shahlahaleem@yahoo.co.in8384882732

Outcome results

None listed

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