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A study to compare the characteristics of premixed hyperbaric ropivacaine and fentanyl versus hyperbaric ropivacaine and fentanyl given separately during spinal anesthesia (anaesthesia technique in which drug is injected in lower back of the patient).

Comparison of subarachnoid block characteristics using pre-mixing versus sequential injection of fentanyl and hyperbaric ropivacaine (0.75%) - nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/065735
Enrollment
80
Registered
2024-04-16
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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: M95- Other acquired deformities of musculoskeletal system and connective tissue Health Condition 3: M25- Other joint disorder, not elsewhere classified Health Condition 4: M20-M25- Other joint disorders

Interventions

Intervention1: Pre-mixing of injection fentanyl and hyperbaric ropivacaine 0.75%.: Sandardised anaesthesia protocol will be followed. In sitting position, under all aseptic precautions, 25- gauge Quin

Sponsors

Pt B D Sharma PGIMS, Rohtak Haryana
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: The study will include 80 patients of either sex of age 18-65 years, belonging to American Society of Anesthesiologists (ASA) physical status of I-II scheduled for lower Limb surgery sub-arachnoid block.

Exclusion criteria

Exclusion criteria: Patient refusal to participate Contraindication to spinal anaesthesia Known to allergy to local anaesthesia Pregnancy

Design outcomes

Primary

MeasureTime frame
To compare the total duration of sensory block in both the groups.Timepoint: Sensory block will be assessed at 1 minute interval by using alcohol swab in the mid-clavicular line, bilaterally, till T10 level is achieved. Time will be noted and surgery will be started. However, sensory level will be checked every 1 minute thereafter, till the time the sensory level is noted to be the same for 2 consecutive intervals. This level will be taken as the maximum sensory level achieved and last but one reading, in minutes, will be taken as time to achieve the maximum level.—

Secondary

MeasureTime frame
Onset, highest level attained, motor block, hemodynamics parameters.Timepoint: Motor blockade will be assessed every 5 minutes and the maximum motor level achieved at 20 minutes from the intrathecal injections of drugs , as per modified bromage scale.—

Countries

India

Contacts

Public ContactDr Punit Kumar

Pt B D Sharma PGIMS, Rohtak

parulgrover89@gmail.com7834994170

Outcome results

None listed

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