Surgical technology international
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Randomized Controlled Trial Multicenter Study
A Randomized, Multicenter, Double-Blind Study of Local Infiltration Analgesia with Liposomal Bupivacaine for Postsurgical Pain Following Total Knee Arthroplasty: Rationale and Design of the Pillar Trial.
Liposomal bupivacaine, a prolonged-release formulation of bupivacaine hydrochloride, is indicated for infiltration into the surgical site for postsurgical analgesia. Results from previous total knee arthroplasty (TKA) studies suggest that analgesic efficacy associated with liposomal bupivacaine may be impacted by variability in infiltration technique. The PILLAR study is designed to assess liposomal bupivacaine efficacy in TKA using a standardized infiltration protocol. Materials and Methods/Design: This phase 4, multicenter, randomized, double-blind, controlled, parallel-group study will compare the safety and efficacy of infiltration with liposomal bupivacaine versus standard bupivacaine for postsurgical pain control in adults undergoing primary unilateral TKA. All subjects will receive a standardized pre-surgical analgesic regimen, and will be randomized to receive either liposomal bupivacaine 266 mg/20 mL (admixed with standard bupivacaine 0.5% 20 mL and expanded to a total volume of 120 mL) or bupivacaine 0.5% 20 mL (expanded to a total volume of 120 mL). The study drug will be infiltrated using six syringes (prefilled with 20 mL of study drug solution) to deliver 1-1.5 mL infusions into prespecified periarticular tissues. All subjects will receive standardized postsurgical analgesia and access to rescue medication. The co-primary efficacy endpoints are area under the curve of visual analog scale pain intensity scores from 12-48 hours postsurgery and total postsurgical opioid consumption from 0-48 hours. Secondary efficacy endpoints include other pain assessments, time to first use of rescue medication, discharge readiness, use of skilled nursing facilities, and hospital length of stay. Safety will be evaluated based on adverse events. ⋯ The use of a standardized protocol comparing infiltration of equal volumes of the study drug, designed by experienced investigators to ensure complete coverage of all areas innervating the surgical site while minimizing leakage of study drug, will help define the role of liposomal bupivacaine in the setting of TKA.
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Randomized Controlled Trial Multicenter Study
Closure of midline laparotomies by means of small stitches: practical aspects of a new technique.
Randomized studies support the closure of midline incisions with a suture length to wound length ratio (SL:WL) of more than 4, accomplished with small tissue bites and short stitch intervals to decrease the risk of incisional hernia and wound infection. We investigated practical aspects of this technique possibly hampering the introduction of this technique. Patient data, operative variables and SL:WL ratio were collected at two hospitals: Sundsvall Hospital (SH) and Erasmus University Medical Center (EMC). ⋯ We conclude that calculation of an SL:WL ratio is easily performed. Suturing with the small bite-short stitch interval technique of SH required 5 minutes extra, outweighing the morbidity of incisional hernia. Without a structured implementation to suture with an SL:WL ratio of more than 4, a lower ratio is often achieved.
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Multicenter Study
Safety biocompatibility of gelatin hemostatic matrix (Floseal and Surgiflo) in neurosurgical procedures.
Adequate hemostasis in cranial and spinal surgery is of paramount importance in a neurosurgeon's daily practice. Generalized ooze bleeding from the surgical wall cavities, coming from the dura mater or nervous tissue may be troublesome and may limit visualization in minimally invasive neurosurgery. ⋯ A total of 318 patients undergoing cranial, craniospinal, and spinal procedure with the use of gelatin hemostatic matrix (Floseal and Surgiflo) were enrolled in this clinical study. We compared the different hemostatic techniques using the gelatin hemostatic matrix, and investigated indications, time to bleeding control, and its efficacy and safety in neurosurgery.
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Multicenter Study Clinical Trial
Lift-(gasless) laparoscopic surgery under regional anesthesia.
The objective of this Chapter was to investigate the feasibility and outcome of gasless laparoscopy under regional anesthesia. A prospective evaluation of Lift-(gasless) laparoscopic procedures under regional anesthesia (Canadian Task Force classification II-1) was done at three endoscopic gynecology centers (franchise system of EndGyn(r)). Sixty-three patients with gynecological diseases comprised the cohort. ⋯ All patients were operated without conversion to general anesthesia and without perioperative or anesthesiologic complications. Lift-laparoscopy under regional anesthesia can be recommended to all patients who desire laparoscopic intervention without general anesthesia. For elderly patients, those with cardiopulmonary risks, during pregnancy, or with contraindications for general anesthesia, Lift-laparoscopy under regional anesthesia should be the procedure of choice.