A Dose Finding Study for Pain Relief of a Broken Hip

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by NHS Greater Glasgow and Clyde.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Chief Scientist Office of the Scottish Government
Information provided by:
NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier:
NCT00926666
First received: June 22, 2009
Last updated: August 3, 2009
Last verified: August 2009
  Purpose

Studies have suggested a link with effective pain relief and reduced illness and death in high risk patients. Ultrasound guided nerve blocks have been associated with an increased success rate and allow visualization of all the anatomical structures and the distribution of the local anesthetic on injection. The hospital mortality for patients admitted to hospital from home in the UK in 2006 with a fractured hip is 14.3% (Bottle and Aylin 947-51).

The aim of this clinical trial is to determine the effective dose of local anesthetic to provide pain relief to patients with a broken hip using ultrasound to guide needle insertion. The hospital mortality for patients admitted to hospital from home in the UK in 2006 with a fractured hip was 14.3%. Patients for emergency surgical fixation or replacement of broken hip will be recruited prior to surgical fixation. All patients recruited to this study will receive standard anesthesia and surgical fixation of their broken hip.

The trial can be divided into two sequential parts; the results of part A will be an amount of local anesthetic which will relieve pain of a broken hip in 95% of all patients. Part B will determine the duration of pain relief provided by the amount of local anaesthetic from part A and blood levels of local anesthetic.

In parts A and B a standard pain relieving nerve block to numb the nerves supplying the hip joint will be administered using ultrasound to guide the injection of local anesthetic. The patient will then be observed for 30 minutes during which time the feeling in the upper leg and pain scores will be recorded. Patients with ineffective nerve blocks will be given immediate pain relief and withdrawn from further participation in the study.

In part A the amount of local anesthetic for the next patient will be increased or decreased if the nerve block is ineffective or effective respectively.

In part B the dose will be the same (calculated from the results of part A). In order to determine the duration of pain relief pain scores will be recorded hourly for up to 24 hours. Blood samples will be taken before the pain relieving nerve block and at 5, 10, 20, 30 and 60 minutes afterwards.


Condition Intervention Phase
Femoral Neck Fractures
Drug: Levobupivacaine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Official Title: A Dose Finding Study for Ultrasound Guided Anterior Psoas Compartment Blocks in Patients With a Fractured Neck of Femur?

Resource links provided by NLM:


Further study details as provided by NHS Greater Glasgow and Clyde:

Primary Outcome Measures:
  • Duration of analgesia [ Time Frame: 24 hours after local anaesthetic nerve block ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • VAS resting acute pain scores [ Time Frame: 10 mins, 20 mins and 30 mins after nerve block ] [ Designated as safety issue: No ]
  • Blood pressure, respiratory rate, pulse and oxygen saturations [ Time Frame: 10 mins, 20 mins and 30 mins after nerve block ] [ Designated as safety issue: No ]
  • Liver function tests [ Time Frame: Before nerve block ] [ Designated as safety issue: No ]
  • Venous blood gases [ Time Frame: before nerve block ] [ Designated as safety issue: No ]
  • Serum levels of levobupivacaine [ Time Frame: At 5, 10, 20, 30 and 60 mins after nerve block ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 48
Study Start Date: October 2009
Estimated Study Completion Date: April 2011
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Levobupivacaine
    Dose finding study for levobupivacaine in fractured neck of femur patients. Ultrasound guided anterior psoas compartment nerve block to determine EC50 using up/Down methodology in patient before surgery to fix broken hip.
  Eligibility

Ages Eligible for Study:   35 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Emergency proximal fractured neck of femur for surgical fixation
  • Visual analogue pain score at rest of >=5
  • American Society of Anaesthesiology grading <=4
  • Able to give informed consent
  • Resting visual analogue pain score of greater than 50mm on a 100mm scale before recruitment
  • Patient is able to cooperate with sensory testing of lower limb function

Exclusion Criteria:

  • Abnormal clotting screen (coagulopathy) or thrombocytopenia (< 100,000)
  • Acute mental test score of <=7 at any time preoperatively
  • Allergy to local anaesthetic
  • Contra-indication to levobupivacaine
  • Signs, symptoms or laboratory evidence of local infection or systemic sepsis
  • No pre-existing neurological deficit (sensory or motor) affecting the lower limb
  • Patient with lower limb amputations or other condition affecting sensation in lower limbs
  • Patient with a history of chronic pain
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00926666

Locations
United Kingdom
Western Infirmary Not yet recruiting
Glasgow, Lanarkshire, United Kingdom, G11 7AB
Contact: malcolm watson, Mb Ch B    00442112069    malcolmwatson.wtson@ntlworld.com   
Sub-Investigator: Emily Walker, MM ChB         
Principal Investigator: Alexander Binning, MB chB         
Sub-Investigator: Simone Rowell, Mb ChB         
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
Chief Scientist Office of the Scottish Government
Investigators
Principal Investigator: Malcolm J Watson, MB chB NHS Greater Glasgow and Clyde Health Board
  More Information

No publications provided

Responsible Party: Dr aureen Travers / R+D Cooridator, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT00926666     History of Changes
Other Study ID Numbers: MW001, EURACT 2009-013462-25, R+D:NumberGN09AN334
Study First Received: June 22, 2009
Last Updated: August 3, 2009
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by NHS Greater Glasgow and Clyde:
Ageing
Pain
Pharmacology
Imaging
Anaesthesiology
Musculoskeletal disease

Additional relevant MeSH terms:
Femoral Neck Fractures
Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Leg Injuries
Levobupivacaine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014