Single Shot Fascia Iliaca Block vs Femoral Nerve Block for Analgesia for Surgical Fixation of Hip Fractures

NCT02330302 | Completed

• 1 other identifier: 2014/453/D
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Hip fractures are common in our elderly population and is associated with pain before and after surgery. The current pain management for patients who have undergone surgery for hip fractures include a combination of oral painkillers, opioids (eg morphine) and regional anaesthesia techniques, which involves the injection of local anaesthetic drugs near nerves supplying the hip joint to numb the operation site. As opioids have many side effects, especially in the elderly patients, regional anaesthesia techniques can help to reduce the use of opioids and the related side effects. This may enhance their recovery and length of hospital stay

Conditions

Hip Fracture

Outcome Measures

Primary Outcomes (1)

• Pain scores

  resting and dynamic pain scores are obtained pre-intervention, 30mins post intervention (and on positioning for spinal anaesthesia), 1 hr post-operatively and at 24hrs post intervention

  up to 24 hours

Secondary Outcomes (1)

• opioid requirement/consumption

  for first 24 hrs (including intra operatively) following intervention

Other Outcomes (1)

• complications associated with intervention

  at 24 hrs post intervention

Study Arms (2)

Femoral nerve block

ACTIVE COMPARATOR

Procedure: Ultrasound-guided femoral nerve block Drug: Ropivacaine 0.5% 30mls

Drug: Ropivacaine

Fascia Iliaca block

ACTIVE COMPARATOR

Procedure: Ultrasound-guided suprainguinal approach to fascia iliaca block Drug: Ropivacaine 0.5% 30mls

Drug: Ropivacaine

Interventions

Ropivacaine DRUG

Ultrasound-guided femoral nerve block with Ropivacaine 0.5% 30mls

Also known as: naropin

Femoral nerve block

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for surgical fixation of hip fracture
• Patients with isolated inter-trochantric fracture
• American Society of Anesthesiologists (ASA) physical status 1 to 3
• Patients who are able to give their own consent

You may not qualify if:

• Patients unable to give consent or inability to communicate/ cooperate
• Patients with regular consumption of strong opioids (morphine, oxycodone) or steroids
• Patients with allergy to local anaesthetics or any drugs included in the study
• Patients with contraindications to spinal anaesthesia such as coagulation disorders/ thrombocytopenia and local infection at site of injection

Sponsors & Collaborators

• Changi General Hospital: lead

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

Location

MeSH Terms

Conditions

Hip Fractures

Interventions

Ropivacaine

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Yean Chin Lim, MBBS, MMed

  Changi General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2014
• First Posted: January 1, 2015
• Study Start: August 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: August 1, 2015
• Last Updated: January 25, 2018

Record last verified: 2018-01

Locations

SG (1)