Pain Management in Children Undergoing Supracondylar Humerus Fracture Repair

NCT01812863 | Withdrawn

• 1 other identifier: 2012-14957
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine if US-guided supraclavicular anesthetic blocks reduce postoperative pain, use of rescue medication, and improve functional outcomes in children who underwent surgery for supracondylar humerus fractures.

Conditions

Humeral Fractures; Fractures, Closed

Keywords

Pain Management; Child; Surgery

Outcome Measures

Primary Outcomes (1)

• Rescue medication

  We will record use of extra morphine in the PACU, if needed.

  In PACU following surgery

Secondary Outcomes (4)

• Pain Scores

  First 42 hours after surgery

• Range of Motion

  9-10 weeks postoperatively

• Physical therapy

  9-10 weeks postoperatively

• Vomiting

  First 24 hours after surgery

Other Outcomes (2)

• Nausea

  First 24 hours post-op

• Somnolence

  First 24 hours post-op

Study Arms (2)

Supraclavicular Nerve Block

EXPERIMENTAL

Maximum dose of 5 mL of 0.25% bupivacaine, and we base the dose on a ml/ kg (0.2 ml/kg) with a maximum dose not to exceed 2.5 mg/kg. Bupivacaine is given with 1:200,000 epinephrine

Procedure: Supraclavicular nerve block

No Nerve Block

PLACEBO COMPARATOR

A band-aid will be placed on all patients where a supraclavicular nerve block would have been inserted, and parents will be asked to leave the band-aid on for 3 days to maintain the blindness to the treatment type by the patient.

Procedure: Supraclavicular nerve block

Interventions

Supraclavicular nerve block PROCEDURE

Following injection of morphine, an ultrasound-guided supraclavicular nerve catheter (Angiocath) will be placed in Group 2. All catheters will be placed by one of the anesthesiologist trained in regional pain control using a 25 mm linear US probe in a sterile fashion. If the examination is unchanged from preoperative assessment, an injection block using 5 ml of 0.25% bupivacaine with 1:200,000 epinephrine will be administered. Bupivacaine is a long acting local anesthetic that prevents nerve conduction and action potential initiation by decreasing the permeability of the neuronal membrane to sodium. We use a maximum dose of 5 mL of 0.25% bupivacaine, and we usually base the dose on a ml/kg (0.2 ml/kg) with a maximum dose not to exceed 2.5 mg/kg. This will be well below toxic levels.

No Nerve Block; Supraclavicular Nerve Block

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients between 2 and 10 years old undergoing reduction and closed pinning of supracondylar humerus fractures
• Ability to obtain consent from the parents for participation in the study
• Patient has the ability to follow commands and train preoperatively the finger movements that are needed to determine nerve integrity.
• Written informed consent from the parent or guardian

You may not qualify if:

• Children with significant preoperative swelling in the elbow, as determined by the surgeon, that may lead to compartment syndrome
• Children with the potential for nerve entrapment as demonstrated by preoperative nerve deficit examination
• Children who have any contraindications (relative and absolute) to a supraclavicular block, including anticoagulation or coagulopathy, as well as patients that have active pulmonary disease that may exhibit respiratory compromise in response to potential phrenic nerve palsy or pneumothorax

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead

Study Sites (1)

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Humeral Fractures; Fractures, Closed; Agnosia

Condition Hierarchy (Ancestors)

Arm Injuries; Wounds and Injuries; Fractures, Bone; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Joseph A Janicki, MD

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 14, 2013
• First Posted: March 18, 2013
• Study Start: July 1, 2012
• Primary Completion: March 1, 2013
• Last Updated: March 7, 2018

Record last verified: 2018-01

Locations

US (1)