A Comparison of Clonidine versus Fentanyl as adjuvants to intrathe hyperbaric Bupivacaine in lower limb surgeries.

A Comparison of Clonidine versus Fentanyl as adjuvants to intrathecal 0.5 percent hyperbaric Bupivacaine in lower limb surgeries:A randomized clinical study. - NiL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/01/100772

Enrollment

Registered

2026-01-09

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-02

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: Nil: Nil Intervention2: Bupivacaine with Clonidine: 40 patients who will receive 2.5 ml of 0.5% hyperbaric Bupivacaine + 15 mcg Clonidine (diluted in 0.5 ml sterile normal saline maki

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adult patients of either sex, aged between 18-65 years age. 2. American Society of Anaesthesiologists (ASA) I and II status. 3. Patients undergoing lower limb surgeries. 4. Patient willing to take part in the study.

Exclusion criteria

Exclusion criteria: 1. To assess and compare the onset of sensory block and two segment regression. 2. To assess and compare the onset and duration of motor block. 3. To monitor and compare hemodynamic stability. (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure, Mean Arterial Pressure) 4. To compare the incidence of adverse effects associated with each adjuvant. (Nausea, Vomiting, Pruritus, Bradycardia, Hypotension, Respiratory Depression)

Design outcomes

Primary

Measure	Time frame
To compare the duration of analgesia between the two groupsTimepoint: To compare the duration of analgesia between the two groups	—

Secondary

Measure	Time frame
1. To assess & compare the onset of sensory block & two segment regression. 2. To assess & compare the onset & duration of motor block. 3. To monitor & compare hemodynamic stability. (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure, Mean Arterial Pressure) 4. To compare the incidence of adverse effects associated with each adjuvant. (Nausea, Vomiting, Pruritus, Bradycardia, Hypotension, Respiratory Depression)Timepoint: Sensory block will be assessed bilaterally every 2 minutes till the loss of sensation at T- 10 The highest level of sensory block will be evaluated every 5 mins for 20 mins after the injection, thereafter every 15 mins. Postoperatively, the pain will be assessed every 30 mins using Visual Analog Scale (VAS) between 0 & 10 (0 = no pain, 10 = severe pain)	—

Measure

Time frame

1. To assess & compare the onset of sensory block & two segment regression. 2. To assess & compare the onset & duration of motor block. 3. To monitor & compare hemodynamic stability. (Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure, Mean Arterial Pressure) 4. To compare the incidence of adverse effects associated with each adjuvant. (Nausea, Vomiting, Pruritus, Bradycardia, Hypotension, Respiratory Depression)Timepoint: Sensory block will be assessed bilaterally every 2 minutes till the loss of sensation at T- 10 The highest level of sensory block will be evaluated every 5 mins for 20 mins after the injection, thereafter every 15 mins. Postoperatively, the pain will be assessed every 30 mins using Visual Analog Scale (VAS) between 0 & 10 (0 = no pain, 10 = severe pain)

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Countries

India

Contacts

Public ContactDr Sheetal

Maharaja Agrasen Medical College Agroha Hisar

sheetalbhatia1234@gmail.com9812426301

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 7, 2026