Comparison of Sequential Combined Spinal Epidural Anaesthesia and Single-Shot Spinal Anaesthesia for Lower Limb Orthopaedic Surgery

Block characteristics of Sequential Combined Spinal epidural anaesthesia versus Single shot Spinal Anaesthesia in patients undergoing elective lower limb orthopaedic surgeries: A randomised controlled Trial - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/06/112816

Enrollment

Registered

2026-06-16

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-22

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: Sequential combined spinal epidural anaesthesia: Post negative epidural test dose via the epidural catheter with 3ml Lignocaine 2% with adrenaline (15mcg) 1.5ml

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing elective lower limb orthopaedic surgery Patients of American Society of Anaesthesiology physical states ASA class 1 and 2

Exclusion criteria

Exclusion criteria: Patients having bleeding disorder, local site infection, neurological deficits, anticoagualtion therapy, allergy to local anaesthetic drugs Patient refusal

Design outcomes

Primary

Measure	Time frame
To compare the block characteristics of sequential combined Spinal Epidural Anaesthesia with single shot Spinal anaesthesia in patients undergoing elective lower limb orthopaedic surgeries with respect to: I.Time of Onset of sensory blockade (in min) II.Time of Onset of motor blockade (in min) III.Maximum height of sensory blockade achieved IV.Time taken to achieve T10 level (in min) V.Time taken for two segment regression (in min)Timepoint: The time of induction will be taken as 0 min. parameters will be checked every 5 mins for 30 mins and then every 10mins for the remaining of the surgery	—

Measure

Time frame

To compare the block characteristics of sequential combined Spinal Epidural Anaesthesia with single shot Spinal anaesthesia in patients undergoing elective lower limb orthopaedic surgeries with respect to: I.Time of Onset of sensory blockade (in min) II.Time of Onset of motor blockade (in min) III.Maximum height of sensory blockade achieved IV.Time taken to achieve T10 level (in min) V.Time taken for two segment regression (in min)Timepoint: The time of induction will be taken as 0 min. parameters will be checked every 5 mins for 30 mins and then every 10mins for the remaining of the surgery

—

Secondary

Measure	Time frame
To compare hemodynamic effects of sequential combined Spinal Epidural Anaesthesia with single shot Spinal anaesthesia in patients undergoing elective lower limb orthopaedic surgeries with respect to: I. Heart Rate II. Systolic Blood pressure (SBP) III. Diastolic Blood pressure (DBP) IV. Mean arterial pressure (MAP) V. SpO2Timepoint: The time of induction will be taken as 0 min. parameters will be checked every 5 mins for 30 mins and then every 10mins for the remaining of the surgery;To compare side effects of sequential combined spinal epidural anaesthesia with single shot spinal anaesthesia in patients undergoing elective lower limb orthopaedic surgeries in terms of- I. Nausea II. Vomiting III. Post dural puncture headache. Timepoint: time of end of operation will be taken as 0 hour. The patient will be assessed every hour for the first 6 hours then at 12 hours, 18 hours, 24 hours;To compare sequential combined spinal epidural anaesthesia with single shot spinal anaesthesia in patients undergoing elective lower limb orthopaedic surgeries in terms of postoperative analgesia.Timepoint: time of end of operation will be taken as 0 hour. The patient will be assessed every hour for the first 6 hours then at 12 hours, 18 hours, 24 hours	—

Measure

Time frame

To compare hemodynamic effects of sequential combined Spinal Epidural Anaesthesia with single shot Spinal anaesthesia in patients undergoing elective lower limb orthopaedic surgeries with respect to: I. Heart Rate II. Systolic Blood pressure (SBP) III. Diastolic Blood pressure (DBP) IV. Mean arterial pressure (MAP) V. SpO2Timepoint: The time of induction will be taken as 0 min. parameters will be checked every 5 mins for 30 mins and then every 10mins for the remaining of the surgery;To compare side effects of sequential combined spinal epidural anaesthesia with single shot spinal anaesthesia in patients undergoing elective lower limb orthopaedic surgeries in terms of- I. Nausea II. Vomiting III. Post dural puncture headache. Timepoint: time of end of operation will be taken as 0 hour. The patient will be assessed every hour for the first 6 hours then at 12 hours, 18 hours, 24 hours;To compare sequential combined spinal epidural anaesthesia with single shot spinal anaesthesia in patients undergoing elective lower limb orthopaedic surgeries in terms of postoperative analgesia.Timepoint: time of end of operation will be taken as 0 hour. The patient will be assessed every hour for the first 6 hours then at 12 hours, 18 hours, 24 hours

—

Countries

India

Contacts

Public ContactDr Aditi Kamdar

NKP Salve institute of Medical Sciences and Research Centre and Lata Mangeshkar Hospital

bhargavasumita@yahoo.in7709428071

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026