Clinical Trials Logo

Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02744352
Other study ID # 823323
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date October 2016
Est. completion date October 5, 2018

Study information

Verified date March 2020
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare infraclavicular brachial plexus shot single shot block to continuous catheter nerve block done in adult patients who have under gone surgery to repair distal radius fractures. Visual analogue scores, opioid consumption, quality of recovery and quality of sleep up to 72 hours post operatively will be used for comparison.


Description:

If the patient is willing to participate and signs the consent, he/she will be randomized to one of the two treatment groups:

1. Single shot block

2. Continuous catheter

In the institution investigators usually advocate for regional anesthesia and intravenous sedation for the repair of open fracture of the distal radius.

Patients will be monitored during block performance with standard ASA monitors. All patients will receive 2 L of oxygen via a nasal cannula. Sedatives will be titrated to effect. Midazolam 1-2 mg, and fentanyl 50-100 mcg will be used for sedation.

Block time out will be preformed according to standard operating procedure. All blocks will be done under ultrasound guidance. Sonosite S nerve machine will be used with a low frequency curvilinear (C5) US probe with 2-5 MHZ frequency. Both single shot and continuous ICB will be performed according to the SOP in the department. Ultrasound survey of the deltopectoral groove below the clavicle will take place. The axillary artery and the three cords (posterior, medial and lateral) of the brachial plexus will be identified in short axis view deeper to the pectoralis minor muscle.

For single shot blocks: A 4 inch 21 gauge single shot (B-Braun) needle will be introduced in-plane towards the posterior cord of the brachial plexus and 1-2 mL of dextrose 5% (D5%) bolus will be used to verify correct placement of the needle in the vicinity of the posterior cord and adequate spread pattern to both lateral and medical cord. 20 ml of of Ropivicaine 0.5% will be injected through the needle with intermittent aspiration after each 5 ml bolus injection.

For the continuous block: A 4 gauge 18 inch tuohy needle ( B -Braun) will be introduced towards the posterior cord as above. When the needle tip and the pattern of spread is confirmed using D5% solution, a 21 gauge catheter will be introduced 2 cm beyond the needle tip under ultrasound visualization. The needle will be withdrawn over the catheter. Injection of a total of 20 ml of ropivacaine 0.5% ( in divided 5 ml boluses with intermittent aspiration) will take place through the catheter while observing the spread of local anesthetic under ultrasound. The catheter hub will be affixed to the upper lateral chest with sterile occlusive dressings and an anchoring device.

Block success will be defined as a change in cutaneous sensation to touch with an alcohol pad in the posterior, medial and lateral cord distribution over the forearm and the hand within 30min after injection. Subjects with successful catheter placement per protocol and nerve block onset will be retained in the study. Subjects with a failed catheter insertion or misplaced catheter indicated by a lack of sensory changes will have their catheter replaced or will be single shot blocked and withdrawn from the study.

Intraoperative sedation will consist of intermittent boluses of midazolam (1-2 mg), fentanyl (50-100 mcg) and propofol infusion, titrates to sedation and patient comfort (25-50 mcg/kg/min).

All patients will receive prophylaxis for postoperative nausea and vomiting (PONV) during surgery. The protocol for prophylaxis against PONV includes administration of 4 mg of dexamethasone after induction of anesthesia and 4 mg of ondansetron 20 minutes before recovery from anesthesia. Dexamethasone is withheld if the patient has poorly controlled diabetes mellitus (DM). Uncontrolled DM will be defined as random blood glucose above 250 mg/dl.


Recruitment information / eligibility

Status Terminated
Enrollment 8
Est. completion date October 5, 2018
Est. primary completion date October 5, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients scheduled for open reduction and internal fixation of a distal radius fracture

- American Society of Anesthesiologists (ASA) physical status I -III

- Mentally competent and able to give consent for enrollment in the study

Exclusion Criteria:

- Patient younger than 18 years old

- Allergy to local anesthetics, systemic opioids (fentanyl, morphine, hydromorphone and any of the drugs included in the standard of care

- Patients opting to go under general anesthesia and those refusing the block

- Chronic pain syndromes; Patients will be defined to have chronic pain if they are using regular daily doses of systemic narcotics for the past 6 months prior to the surgery

- BMI of 40 or more

Study Design


Intervention

Drug:
20ml bolus of 0.5% ropivicaine
Local anesthetic
0.2% of ropivacaine at 8 milliliter/hour
Local anesthetic

Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain Scores as Measured by the Visual Analog Scale Pain scores at rest and with movement. 72 hours
Primary Participants Need for Pain Relief as Measured by Opiate Consumption Amount of opiate consumption 72 hours
Secondary Quality of Recovery Score Score of QoR survey to determine recovery status 72 hours
Secondary Number of Subjects With Insomnia as Measured by Sleep Questionnaire Quality of sleep first 2 nights post surgery 48 hours
Secondary Range of Motion as Measured by the Disability Assessment of Shoulder and Hand Questionnaire Dash questionnaire to measure range of motion of the wrist and fingers 3 months after surgery 3 months
See also
  Status Clinical Trial Phase
Recruiting NCT05736068 - Is Casting of Displaced Pediatric Distal Forearm Fractures Non-inferior to Reduction in General Anesthesia? N/A
Completed NCT04554472 - Usefulness of Intraoperative Ultrasound in a Volar Plate Distal Radius Fixation
Completed NCT03613922 - Effects of Early Manual Therapy on Functional Outcomes After Volar Plating of Distal Radius Fractures N/A
Completed NCT01823692 - Evaluating Validity of Ultrasonography in Determining Distal Radius Fracture Reduction Phase 2
Completed NCT02286661 - Short-Arm Casting Effective in Type A2 Fractures in the Distal Radius N/A
Completed NCT01062997 - Volar Locked Plating Versus Bridging External Fixation N/A
Not yet recruiting NCT04100317 - Spanning Bridged Plate in Comminuted Distal Radius Fractures
Recruiting NCT04976335 - Quantitative and Clinical Assessment of Flexor Tendon Gliding Following Application of a Bioresorbable Hydrogel: A Prospective, Randomized Study in Patients Undergoing Distal Radius Fracture Repair N/A
Completed NCT03635060 - Distraction Osteogenesis for Distal Radius Fractures vs. Volar Plating N/A
Not yet recruiting NCT05095415 - Occupational Therapy Pre-operative Education in the Orthopedic Hand Setting N/A
Completed NCT05558306 - Radiological vs Clinical Outcome in DRF N/A
Completed NCT01778673 - Cortical Comminution and Intra-articular Involvement in Distal Radius Fractures Can Predict Radiological Outcome. A Prospective Multicenter Study N/A
Active, not recruiting NCT03349216 - Bier's Block Versus Systemic Analgesia Phase 2
Completed NCT04357470 - Manual Dexterity in Ulnar Styloid Fracture Patients N/A
Completed NCT05360836 - The Effect of Motor Imagery in Patients With Radius Distal End Fracture N/A
Recruiting NCT02957240 - Graded Motor Imagery for Women at Risk for Developing Type I CRPS Following Closed Treatment of Distal Radius Fractures N/A
Completed NCT03240471 - Cast OFF Trial: One Versus Four-five Weeks of Plaster Cast Immobilization N/A
Terminated NCT04089709 - Well-arm Exercise in Distal Radius Fractures N/A
Completed NCT05623865 - The Effect of Kinesio Taping on Edema Control and Wrist Functions in Conservatively Followed Distal Radius Fractures. N/A
Enrolling by invitation NCT04632745 - A Study Evaluating Splinting and Casting for Distal Radius Fractures in the Elderly N/A