title: Oxiplex reduces leg pain, back pain, and associated symptoms after lumbar discectomy.
abstract: METHODS
  Prospective, randomized, blinded clinical trial.
  
  
  OBJECTIVE
  To evaluate effectiveness of Oxiplex gel for reduction of pain and associated symptoms after lumbar discectomy.
  
  
  BACKGROUND
  Oxiplex gel (carboxymethylcellulose, polyethylene oxide, and calcium) is used during discectomy to coat the surgical site for reduction of pain and symptoms after lumbar discectomy.
  
  
  METHODS
  Patients undergoing single-level lumbar discectomy performed by laminectomy or laminotomy and randomized to receive either surgery plus Oxiplex gel (treatment group) or surgery alone (control group) were assessed 6 months after surgery using (1) a quality of life questionnaire (Lumbar Spine Outcomes Questionnaire [LSOQ]) and (2) clinical evaluations.
  
  
  RESULTS
  There were no statistically significant differences in baseline demographics, surgical procedures, LSOQ scores, and clinical evaluations between treatment (N = 177) and control (N = 175) groups. More gel-treated patients were satisfied with outcome of their surgical treatment than control patients (P = 0.05). The gel-treated group showed greater reductions in pain and symptoms from baseline compared with surgery-only controls. Additional benefits of gel were consistently shown in reduction of leg and back pain at 6 months in the patient population having substantial back pain at baseline (greater than or equal to the median LSOQ pain score of 63). In that population, there was a statistically significant reduction of leg pain and back pain (P < 0.01) in the treatment group compared with controls. Fewer patients in the treatment group had abnormal musculoskeletal physical examinations at 6 months compared with controls. There were no cases of cerebrospinal fluid leaks and no differences in laboratory values or vital signs. Patients in the treatment group had less hypoesthesia, paraesthesia, sensory loss, and fewer reoperations during the 6-month follow-up than controls (1 vs. 6).
  
  
  CONCLUSIONS
  These data demonstrate improvements in clinical outcomes resulting from the use of Oxiplex gel in discectomy procedures for treatment of lumbar disc herniation.
authors: OrthoCarolina Spine Center, Charlotte, NC, USA.
authors: Alfred L
authors: AL
authors: Rhyne
authors: Scott L
authors: SL
authors: Blumenthal
authors: Edmund H
authors: EH
authors: Frank
authors: Ken Y
authors: KY
authors: Hsu
authors: Kee D
authors: KD
authors: Kim
authors: Jim A
authors: JA
authors: Youssef
authors: Jeffrey C
authors: JC
authors: Wang
authors: Paul
authors: P
authors: Arnold
authors: Mohammed
authors: M
authors: BenDebba
authors: Kathleen M
authors: KM
authors: Block
authors: Thomas G
authors: TG
authors: Juarez
authors: Richard P
authors: RP
authors: Chiacchierini
authors: Ronald J
authors: RJ
authors: Ehmsen
authors: John S
authors: JS
authors: Krelle
authors: Gere S
authors: GS
authors: diZerega
mesh_terms: D000328:Adult; D000368:Aged; D001416:Back Pain / Q000188:drug therapy*; D002482:Cellulose / Q000031:analogs & derivatives* / Q000627:therapeutic use; D017586:Diskectomy / Q000009:adverse effects*; D005260:Female; D006801:Humans; D007403:Intervertebral Disc / Q000601:surgery; D007405:Intervertebral Disc Displacement / Q000601:surgery; D007796:Laminectomy / Q000009:adverse effects*; D008159:Lumbar Vertebrae / Q000601:surgery; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010149:Postoperative Pain / Q000188:drug therapy*; D017060:Patient Satisfaction; D011092:Polyethylene Glycols / Q000627:therapeutic use*; D011446:Prospective Studies; D011788:Quality of Life; D016037:Single-Blind Method; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: C406630:Oxiplex; D011092:Polyethylene Glycols; D002482:Cellulose