Comparing a patient-controlled pain pump to a regular pump after fixing a broken thigh bone

Patient-controlled epidural analgesia versus conventional epidural analgesia for postoperative pain control in surgery for fractured shaft of femur- a randomized control trial. - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2026/05/110521

Enrollment

Registered

2026-05-12

Start date

Unknown

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

Health Condition 1: S723- Fracture of shaft of femur

Interventions

Intervention1: Patient-Controlled Epidural Analgesia (PCEA): Group P: Patient-Controlled Epidural Analgesia (PCEA) using the Levobupivacaine-Dexmedetomidine mixture. Control Intervention1: Conventiona

Eligibility

Inclusion criteria

Inclusion criteria: All patients undergoing surgery for fractured shaft of femur under combined spinal plus epidural anesthesia along with the following criteria Age: 18 years to 60 years. ASA Grade: I, II on pre-anesthetic evaluation Body Mass Index (BMI): 18 30 kg/m2. Injury: Isolated mid-shaft diaphyseal femur fracture (AO/OTA Type 32) scheduled for reamed intramedullary nailing. Conscious, oriented, cooperative. Written informed consent for participation.

Exclusion criteria

Exclusion criteria: Open fractures (Gustilo-Anderson Grade II or III). Concurrent neurological, thoracic, or abdominal injuries. Known allergy to local anesthetics or dexmedetomidine. Pre-existing coagulopathy or localized infection at the epidural site. History of long-term opioid therapy Indication of revision surgery during immediate post-operative period Inability to comprehend the PCEA pumps mechanism.

Design outcomes

Primary

Measure	Time frame
The primary outcome is the intensity of postoperative pain measured by the Visual Analogue Scale (VAS) at rest and during movement.Timepoint: Assessments will be conducted postoperatively at 2, 4, 8, 12, 24, 48, and 72 hours.	—

Secondary

Measure	Time frame
. Secondary outcomes include patient satisfaction (5-point Likert scale), time to achieve mILAS functional milestones, total analgesic consumption, and safety parameters (incidence of bradycardia, hypotension, and motor block density).Timepoint: Assessments will be conducted postoperatively at 2, 4, 8, 12, 24, 48, and 72 hours	—

Countries

India

Contacts

Public ContactDr Yangyasmit Mohanty

Pandit Raghunath Murmu Medical College and Hospital Baripada

yangyasmit@gmail.com9090213024

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026