Enhanced Recovery After Lumber Laminectomy Using Epidural and General Anesthesia
Condition: Postoperative Recovery; Epidural Blockade; Endotracheal Tube; Laminectomy
Study type: Interventional

Summary: 
      Now, enhanced recovery after surgery (ERAS) is considered an essential goal to improve
      patient satisfaction, increase surgical workflow rate and facilitate performing different
      surgical procedures, including lumber laminectomy, on an ambulatory base. Different ERAS
      protocols have been applied and succeeded to improve recovery profile after colonic, rectal,
      gastric, urologic, biliary, pancreatic, and gynecologic procedures. Up to our knowledge, it
      is the 1st trial that will investigate the effect of combining single shot epidural blockade
      and general anesthesia (GA) using tolerable endotracheal tube (TET), as components for ERAS
      protocol for patients undergoing lumber laminectomy, on postoperative recovery profile. so
      the current study will be done to assess if Single shot epidural blockade and GA using TET,
      for patients undergoing lumber laminectomy, can enhance their postoperative recovery.
    

Detailed description: 
      The study will be carried out at anesthesia and surgical intensive care department -Zagazig
      University Hospitals. Patients of both sexes, assigned to a single or double level lumbar
      laminectomy or discectomy, will be included in the study. all patients will be preoperatively
      evaluated according to standard local protocol. patients, who will not be excluded, will be
      assigned to one of two groups: Group I (control group) patients who will undergo standard
      general anesthetic technique and Group II (combined general/ epidural anesthesia group
      (CGEA)) patients will undergo single shot epidural analgesia [by bupivacaine (15 ml with
      0.25% concentration)] followed by induction of standard general anesthesia (GA) using
      tolerable endotracheal tube (TET)

      Both groups will be compared as regard:

        1. Patient recovery in the form of time to extubation, , time to achieving modified aldrete
           score ≥ 9 , duration of post-anesthesia care unit (PACU) stay and incidence of PACU
           bypass.

        2. Patients' satisfaction, time to Post anesthesia discharge scoring system (PADSS) for
           determining home readiness ≥ 9 and incidence of hospital re-admission

        3. Intra operative hemodynamic stability, blood loss, operative time and surgeon's
           satisfaction.

        4. Postoperative pain scores and analgesic requirements.

      Sample size was calculated using Epi Info 6, based on expected time to modified Aldrete score
      ≥ 9 in group I 13.1± 3.7 in group GA and in group II 7.9 ± 3.2 , confidence interval 95% and
      power of test 80%, to be 32. Eight patients will be added to compensate for dropout, so the
      total number of patients will be 40 patients.

      All data will be collected, tabulated and statistically analyzed using SPSS 20.0 for windows
      (SPSS Inc., Chicago, IL, USA) and MedCalc 13 for windows (MedCalc Software bvba, Ostend,
      Belgium). According to the type of data qualitative data will be represented as number and
      percentage, parametric quantitative data will be represented by mean ± standard deviation
      (SD), non-parametric data will be presented as median and range and the following tests were
      used to test differences for significance and association of qualitative variable by Chi
      square test (X2). Differences between quantitative multiple by student t-test or Mann Whitney
      test as appropriate. P value was set at <0.05 for significant results.
    

Intervention name(s): (Epidural /GA using tolerable endotracheal tube (TET) group, group II; standard general anesthetic technique, control group, group I
Intervention type(s): Procedure; Procedure
Intervention description(s): patients will undergo a single shot epidural bupivacaine (15 ml with 0.25% concentration) followed by a standard general anesthetic technique in which the trachea was intubated using TET, through its side port 2mg/kg , lidocaine 2% will be sprayed immediately after intubation when the patient is in flat supine position then the same dose of lidocaine will be repeated 10 minutes before anesthetic discontinuation.; patients will undergo standard general anesthesia with classic endotracheal tube
Intervention MeSH terms: Anesthetics; Anesthetics, General
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: enhanced recovery; epidural anesthesia; tolerable endotracheal tube; general anesthesia; laminectomy