Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00876746
Other study ID # Supra / Infra Catheters
Secondary ID
Status Completed
Phase Phase 4
First received April 3, 2009
Last updated June 14, 2010
Start date December 2008
Est. completion date January 2010

Study information

Verified date April 2009
Source University of California, San Diego
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

This research study is to determine if the insertion site of a perineural catheter or tiny tube placed next to the nerves that go to the part of the body (hand or arm) having surgery, affects the amount of pain relief that is experienced after surgery. Catheters will be placed in either the supraclavicular or infraclavicular location.


Description:

To determine if a particular perineural local anesthetic catheter location (supraclavicular or infraclavicular) will maximize postoperative analgesia, minimize oral opioid requirements, minimize sleep disturbances resulting from postoperative pain, and maximize patient satisfaction.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date January 2010
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 18 years of age or older

- unilateral, upper (at or distal to the elbow) extremity orthopedic surgery with moderate-to-severe postoperative pain expected

- patients already agree to and want a continuous brachial plexus block for postoperative analgesia

Exclusion Criteria:

- patients who have difficulty understanding the study protocol or caring for the infusion pump/catheter system

- patients who have any known contraindication to study medications

- insulin-dependent diabetes mellitus

- neuropathy of any etiology in the affected extremity

- contraindication to regional blockade (e.g. clotting deficiency)

- any known acute or chronic hepatic or renal insufficiency or failure

- any incision site outside of the catheter-effected area

- chronic opioid use

- history of opioid abuse

- obesity

- pregnancy

- incarceration

- inability to communicate with the investigators and hospital staff

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Procedure:
Supraclavicular vs. Infraclavicular ropivicaine infusion
Patients will be randomized to one of two groups: nerve blocks in the supraclavicular location or the infraclavicular location. Following surgery the patient will be called by study staff to assess pain scores, sleep disturbances, infusion side effects, feeling in fingers and other study outcomes.

Locations

Country Name City State
United States UCSD Medical Center San Diego California

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Surgical pain as measured on a 0-10 scale where 0=no pain and 10=worst imaginable pain. The values for the two different catheter locations will be compared to see which site is optimal for catheter placement. 3 days No
Secondary Opioids consumed by patient each day after surgery as reported to study staff. 3 days No
Secondary Sleeping disturbances (difficulty sleeping and awakenings due to pain) as reported to the study staff. 3 days No
Secondary Infusion side effects (shortness of breath) as reported to study staff. 3 day No
Secondary Satisfaction with pain control as measured on a 0-10 scale where 0=very unsatisfied and 10=very satisfied, as reported to study staff at time of daily phone calls 3 days No
Secondary Sensory and motor deficits (ability to move fingers and numbness of fingers) as reported to study staff. 3 days No
Secondary Catheter site discomfort, leakage at catheter site, and catheter related pain on the 0-10 rating scale, where 0=no pain and 10=worst imaginable pain, as reported to study staff during phone calls. 3 days No
See also
  Status Clinical Trial Phase
Completed NCT02489526 - Evaluate the Analgesic Efficacy and Safety of VVZ-149 Injections for Post-Operative Pain Following Colorectal Surgery Phase 2
Terminated NCT05146453 - Sternotomies and PectoIntercostal Fascia Blocks in Fast-Track Cardiac Anesthesiology Phase 4
Completed NCT05635916 - Trial of Liposomal Bupivacaine for TKA Phase 4
Recruiting NCT06028126 - Superficial Parasternal Intercostal Plane Block in Cardiac Surgery Trial N/A
Not yet recruiting NCT03591172 - Using Three Different Final Irrigants and Showing Their Effects on the Success of Revascularization N/A
Completed NCT01667445 - Evaluation of the Use of Spinal Epimorph in Total Knee Arthroplasty Phase 4
Completed NCT01686802 - Post-operative Oral Morphine Versus Ibuprofen Phase 2
Completed NCT01444924 - Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery Phase 2
Completed NCT00968955 - Effect of Local Infiltration Analgesia in Total Hip Arthroplasty Phase 4
Completed NCT00830089 - Trial of a Transversus Abdominis Plane (TAP) Block in Laparoscopic Colorectal Surgery N/A
Completed NCT00847093 - LMX-4 for Postoperative Pain Management in Infants and Children Undergoing Penoplasty Surgery Phase 4
Terminated NCT00875862 - Shoulder Adhesive Capsulitis and Ambulatory Continuous Interscalene Nerve Blocks Phase 4
Completed NCT00390312 - Efficacy and Safety of Intranasal Morphine for Pain After Third Molar Extraction Phase 2
Recruiting NCT05278494 - Dextromethorphan for Treatment of Postoperative Pain N/A
Recruiting NCT05973045 - Investigation of the Effect of Distention Medium Temperature on Image Quality, Hyponatremia Risk, and Post-operative Pain in Operative Hysteroscopy N/A
Not yet recruiting NCT04999670 - Fascial Closure and Post-caesarean Pain N/A
Enrolling by invitation NCT04346407 - Dronabinol for Post-operative Pain After Lumbar Fusion Phase 4
Completed NCT03635515 - Occurrence of Post-op Pain Following Gentlewave N/A
Terminated NCT03201809 - Comparison of Preoperative Ultrasound Guided Pectoralis Nerve Block Placement Versus Intra-operative Placement: A Prospective Randomized Trial N/A
Completed NCT03254056 - Fascial Closure Techniques Post-Operative Pain Laparoscopy N/A