A study to find the effect of two different drugs Dexamethason and fentanyl on popliteal block for leg surgeries

“ A prospective randomized controlled study comparing Dexamethasone and Fentanyl as adjuvant to Bupivacaine in ultrasound guided popliteal sciatic nerve block in below knee surgeries - not applicable

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/01/061206

Enrollment

Registered

2024-01-08

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

Health Condition 1: PCS- Health Condition 2: M205- Other deformities of toe(s) (acquired)

Interventions

Intervention1: Group I and Group II: ultra sound guided popliteal block with addition of adjuvant dexamethasone in group I with Buppivacaine in comparison to fentanyl with bupivacain. Control Interve

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either Gender 2. Patients aged between 18-70 years 3. Patients with BMI between 18.5 and 29.9 kg/m2 4. Patients with ASA grade1, 2 and 3 5. Patients posted for elective below knee surgery

Exclusion criteria

Exclusion criteria: 1. Patient refusal 2. Patients with known hypersensitivity or contraindications to the study drugs 3. Infection at the site of block 4. Patients with advanced renal, hepatic, respiratory or cardiac diseases 5. Patients with severe coagulopathy 6. Pregnant patients 7. Patients with neurological, psychiatric or neurovascular disorders 8. Patient with alcohol/drug abuse

Design outcomes

Primary

Measure	Time frame
To compare the effectiveness of adding Dexamethasone and Fentanyl to Bupivacaine on duration of sensory and motor blockade of the popliteal sciatic nerve block in below knee surgeries. This is done by observing and assessing the 1.Time to the onset of the sensory block 2.Time to the onset of the motor block 3.Duration of motor block 4.Duration of sensory block 5.Time of request of first rescue analgesic (which indicates the duration of post operative analgesia) This study will be demonstrated with adding Fentanyl (1mcg/kg) and 8 mg of dexamethasone as an adjuvant to 0.5% bupivacaine for the popliteal nerve block in patients undergoing ankle and foot surgeries. Were one of the group is expected to show decreases time of onset of anaesthesia, shows significant increase in duration of sensory and motor blockade and also increases the post operative analgesia. Timepoint: ONSET OF SENSORY BLOCK: After injection of the solution (time zero) every patient will be checked in the following times: 0, 5, 10, 15, 20 and 30 minutes for onset of sensory blockade using pinprick test using the following scale (three-point scale) ONSET OF MOTOR BLOCK: After injection of the total dose of LA (time zero) every patient will be checked in the following times 0, 5, 10,15, 20 and 30	—

Measure

Time frame

To compare the effectiveness of adding Dexamethasone and Fentanyl to Bupivacaine on duration of sensory and motor blockade of the popliteal sciatic nerve block in below knee surgeries. This is done by observing and assessing the 1.Time to the onset of the sensory block 2.Time to the onset of the motor block 3.Duration of motor block 4.Duration of sensory block 5.Time of request of first rescue analgesic (which indicates the duration of post operative analgesia) This study will be demonstrated with adding Fentanyl (1mcg/kg) and 8 mg of dexamethasone as an adjuvant to 0.5% bupivacaine for the popliteal nerve block in patients undergoing ankle and foot surgeries. Were one of the group is expected to show decreases time of onset of anaesthesia, shows significant increase in duration of sensory and motor blockade and also increases the post operative analgesia. Timepoint: ONSET OF SENSORY BLOCK: After injection of the solution (time zero) every patient will be checked in the following times: 0, 5, 10, 15, 20 and 30 minutes for onset of sensory blockade using pinprick test using the following scale (three-point scale) ONSET OF MOTOR BLOCK: After injection of the total dose of LA (time zero) every patient will be checked in the following times 0, 5, 10,15, 20 and 30

—

Secondary

Measure	Time frame
3. Duration of motor block 4. Duration of sensory block 5. Time of request of first rescue analgesic (which indicates the duration of post operative analgesia) Timepoint: 0 min- time of removal of block needle. 0,5, 10, 15, 20, 30,45,60min,90min,120min,150min,180min,210min,240min,360min,480min,720min,1440min.	—

Countries

India

Contacts

Public ContactRaveena Ragavi C G V

Sri Muthukumaran Medical college and research institute

drrvanaes@gmail.com9444066434

Outcome results

None listed

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