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Orthopedic Surgery clinical trials

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NCT ID: NCT01063543 Completed - Orthopedic Surgery Clinical Trials

Pharmacokinetics of Fondaparinux in Patients With Major Orthopedic Surgery

POP-A-RIX
Start date: September 2004
Phase: N/A
Study type: Observational

Fondaparinux is a synthetic antithrombotic agent with specific anti-factor Xa activity. A population pharmacokinetic model of fondaparinux, based on data obtained in patients included in phase II/III trials, has been described. However, the validity of this model in everyday practice needed to be confirmed. This study was a multicenter, prospective cohort study in consecutive orthopedic patients treated with 2.5 mg of fondaparinux. Anti-Xa activities were recorded in 809 patients. Population parameters and inter-individual variability were estimated using NONMEM VI software. A two-compartment model with first-order absorption best described fondaparinux pharmacokinetics. Covariates partly explaining inter-individual variability were body weight, age and creatinine clearance estimated by the simplified Modification of Diet in Renal Disease formula. A body weight less than 50 kg and moderate renal failure increased drug exposure. These results suggest that fondaparinux pharmacokinetics need to be confirmed in patient populations not fully assessed in phase II/III studies

NCT ID: NCT01050738 Recruiting - Clinical trials for Rheumatoid Arthritis

Local Analgesia in Knee- and Hipatroplastic Surgery in Patients With Rheumatic Disease: Extra- vs. Intracapsulare Position of Catheter

Start date: January 2010
Phase: N/A
Study type: Interventional

Postoperative pain is part of surgery trauma. In orthopedic surgery artroplastic replacement of knee- and hipjoints are common. Postoperative pain relieve can be complicated. A new concept for pain relieve postoperative is local infiltration analgesia (LIA). This technique implicates that a catheter is left in the surgical area and that local anestesia can be administered post surgery. The goal is no or only little pain with minimal side effects. The catheter could be placed intra- or extracapsulare. The best position is not known. Primary aim is to study if position of the catheter effects the need of other postoperative analgesia. Secondary aim is to study if the position effects patient mobility within the first two days.

NCT ID: NCT01019005 Not yet recruiting - Orthopedic Surgery Clinical Trials

Pain Relief After Forefoot Surgery

Start date: February 2010
Phase: N/A
Study type: Interventional

The aim to test whether continues local anaesthetic infusion via tibial catheter or wound catheter will improve pain relief following forefoot surgery In this sequential prospective randomised, controlled clinical trial,75 Patients undergoing forefoot surgery will be randomized into three groups (tibial, wound, control). All groups will receive ankle block ± general anesthetic (standard technique). The tibial group will have a tibial catheter inserted through which local anaesthetic will be infused. The wound group will have a catheter inserted directly into the wound immediately after surgery. The control group will have a sham catheter (covered by a bandage across foot) attached to a pump which will not infuse. Patient maximum pain scores (primary outcome measure), nausea/ vomiting, analgesia use, satisfaction and sleep disturbance will be recorded postoperatively. All groups will be then followed by telephone calls 48 hours. Patients will be instructed to come to the clinic on the 4th postoperative day where the catheter will be removed.

NCT ID: NCT00724035 Completed - Trauma Clinical Trials

Ultrasound-Guided Axillary or Infraclavicular Nerve Block for Upper Limb Surgery

Start date: May 2008
Phase: Phase 4
Study type: Interventional

This study aims to detect differences in onset time of brachial plexus (i.e., arm) anesthesia using two different nerve block techniques. Using ultrasound guidance, axillary (i.e., at the armpit) and infraclavicular (i.e., below the collarbone) blocks will be performed to patients undergoing upper limb surgery. The investigators will analyze how long it takes for anesthesia to be adequate for pain-free surgery, thus determine the optimal technique for this kind of surgery.

NCT ID: NCT00702416 Completed - Nerve Block Clinical Trials

Ultrasound Guidance for Interscalene Brachial Plexus Block

Start date: May 2008
Phase: Phase 4
Study type: Interventional

This study has been designed to assess the possible advantages of using ultrasound imaging to block the brachial plexus (i.e., nerves of the upper limb) in patients undergoing shoulder surgery. The ultrasound technique will be compared with the current gold standard, electrical nerve stimulation. The aim of this study is to define which technique is better in terms of time to onset of anesthesia.

NCT ID: NCT00670826 Not yet recruiting - General Anesthesia Clinical Trials

Comparison Study of Intraoperative Patient Warming Systems

Start date: July 2008
Phase: N/A
Study type: Interventional

Medications used to put people to sleep during surgical procedures also cause changes in the body's ability to control its temperature. These changes can make a person's temperature drop below normal. To minimize this drop in body temperature, different types of body warming products are used during surgery. This study is designed to compare the the temperatures of people under general anesthesia after 60 minutes of warming with each product. The study hypothesis is that the people warmed with the Dynatherm Medical vitalHEAT vH2 System will decrease less in the first 60 minutes of warming time than people warmed with the Arizant Bair Hugger System.

NCT ID: NCT00293631 Completed - Orthopedic Surgery Clinical Trials

Study of Lornoxicam or Ketorolac or Placebo for Post-Operative Pain After Bunionectomy

Start date: November 2005
Phase: Phase 2
Study type: Interventional

To determine whether a single dose of intravenous lornoxicam is superior to intravenous placebo for management of post-operative pain in patients who have surgical removal of a bunion on the lower extremity. One-fourth of patients in this study will receive a single dose of intravenous ketorolac for management of pain and one-fourth of patients in this study will receive a single dose of an intravenous placebo.

NCT ID: NCT00270075 Completed - Blood Transfusion Clinical Trials

A Study to Determine the Safety and Effectiveness of Epoetin Alfa in Facilitating Self-donation of Blood Before Surgery in Patients Who Are Not Anemic and Who Will be Undergoing Orthopedic or Heart and Blood Vessel Surgery

Start date: January 1990
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to determine whether epoetin alfa will enable self-donation of at least 4 units of blood during the 2-week period before surgery (which is a shorter period of time than the conventional 3-week blood donation period before surgery) in patients who are not anemic and who will be undergoing orthopedic or heart and blood vessel surgery. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.

NCT ID: NCT00270023 Completed - Blood Transfusion Clinical Trials

A Study to Determine the Effectiveness of Epoetin Alfa in Facilitating Self-donation of Blood Before Surgery in Non-anemic Patients Who Are Undergoing Orthopedic, Heart and Blood Vessel, or Breast Reduction Surgery; Performed in Combination With a Procedure to Reduce Blood Loss During Surgery.

Start date: n/a
Phase: Phase 2/Phase 3
Study type: Interventional

The purpose of this study is to determine the safety and effectiveness of epoetin alfa and whether epoetin alfa will enable self-donation of blood during an 11-day period before surgery (which is shorter than the conventional 3-week blood donation period before surgery) in patients who are not anemic and who will be undergoing orthopedic, heart and blood vessel, or breast reduction surgery. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production. Normovolemic hemodilution (NVHD, withdrawal of a patient's blood immediately before surgery, immediate replacement of blood with an equal volume of fluid, and return of the withdrawn blood after completion of surgery; a procedure which reduces the loss of blood during surgery) will also be performed.

NCT ID: NCT00269971 Withdrawn - Anemia Clinical Trials

A Study to Determine an Effective Dose of Epoetin Alfa to Decrease the Number of Units of Blood Required to be Transfused During Hip Replacement Surgery.

Start date: May 1996
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine an effective dose of epoetin alfa to be administered prior to surgery, to decrease the need for blood transfusions during hip replacement. Epoetin alfa is a genetically engineered protein that stimulates red blood cell production.