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Comparison of effects of mixed versus sequential adminstration of levobupivacaine and fentanyl in spinal anaesthesia for leg surgeries.

Comparison of effects of mixed versus sequential adminstration of levobupivacaine and fentanyl in subarachnoid block for lower limb surgeries:A randomized control study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/08/035540
Enrollment
120
Registered
2021-08-09
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: O- Medical and Surgical Health Condition 2: T07- Unspecified multiple injuries

Interventions

Intervention1: Levobupivacaine: Effect of Levobupivacaine and fentanyl when given in sequence or as a mixture for subarachnoid block will be studied in lower limb surgeries. Control Intervention1: Lev

Sponsors

Sharda hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients of age between 18-65 years. American Society of Anaesthesiologists (ASA) grade I&II Scheduled for lower limb surgeries under subarachnoid block

Exclusion criteria

Exclusion criteria: 1)Patient refusal to participate in the study 2)Any History of allergy to the study medication 3)Any history of clotting or bleeding disorder 4)Infection at the site of lumbar puncture 5)Patients with pre existing neurological deficit 6)Any history of psychiatric illness Pregnant patients

Design outcomes

Primary

MeasureTime frame
1.To compare subarachnoid block characteristics after mixed versus sequential administration of levobupivacaine and fentanyl for lower limb surgeries. 2.To compare intraoperative hemodynamic parameters between the three groups. Timepoint: 1)Sensory block was assessed by a sterile pin prick every 2 min till 20 min and then after every 10 min till the highest level was achieved. 2)Onset was defined as the loss of sensation at T10 dermatome. The time to onset of motor block was defined as time taken to reach Modified Bromage score of 4. 3)Time of regression of motor block was assessed as time to reduce to from maximum attained Modified Bromage score to score of 0.

Secondary

MeasureTime frame
1.To compare the duration of postoperative analgesia between the three groups. 2.To evaluate opioid related side effects in the three groups. Timepoint: Analgesia remaining in the postoperative period will be assessed by VAS scale at hourly intervals for eight hours after completion of surgery

Countries

India

Contacts

Public ContactDr Harsh Vardhan

School of Medical Sciences and Research,Greater Noida.

harshvardhan23@hotmail.com9871952687

Outcome results

None listed

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