Enhanced Recovery After Lumber Laminectomy Using Epidural and General Anesthesia

Study Overview
=================
Brief 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: 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. Patients' satisfaction, time to Post anesthesia discharge scoring system (PADSS) for determining home readiness ≥ 9 and incidence of hospital re-admission Intra operative hemodynamic stability, blood loss, operative time and surgeon's satisfaction. 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.

Official Title
-----------------
Enhanced Recovery After Lumber Laminectomy Using Combined Epidural and General Anesthesia With Tolerable Endotracheal Tube

Conditions
-----------------
Postoperative Recovery, Epidural Blockade, Endotracheal Tube, Laminectomy

Intervention / Treatment
-----------------
* Procedure: (Epidural /GA using tolerable endotracheal tube (TET) group, group II
* Procedure: standard general anesthetic technique, control group, group I


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American society of anesthesiologists (ASA) grade I-II body mass index (BMI) < 30 kg/m2 assignment to a single or double level lumbar laminectomy or discectomy Exclusion Criteria: Patient's refusal of the procedure local infection at site of catheter insertion recurrent disc surgery, emergency surgery coagulopathies hemoglobin <8 g/dl history of stroke or psychiatric disease baseline neurological deficit active upper respiratory tract infections history of either laryngeal / tracheal surgery or pathology uncontrolled hypertension or diabetes mellitus (DM), cardiac, pulmonary, hepatic or renal dysfunction any contraindication for study technique or medications being on regular steroids, opioid analgesics or alpha 2 agonists.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: control group, group I<br>standard general anesthetic (GA) technique | Procedure: standard general anesthetic technique, control group, group I<br>* patients will undergo standard general anesthesia with classic endotracheal tube<br>|
| Active Comparator: Epidural /GA using TET group, group II<br>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 tolerable endotracheal tube (TET) | Procedure: (Epidural /GA using tolerable endotracheal tube (TET) group, group II<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to achievement of phase I recovery criteria | time to achievement of modified Aldrete score ≥ 9 after GA or CGEA. modified aldrete score (0- 10) higher score is better score | the period of time (mins) starting from extubation to achievement of modified Aldrete score ≥ 9. estimated period of time 30 minutes | 
| incidence of successful PACU bypass | number of patients who will achieve a modified Aldrete score ≥ 9 before PACU admission. modified aldrete score (0- 10) higher score is better score | immediately before postoperative patient transfer out from the operating room | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to extubation | Time to achievement of postoperative extubation criteria (eye opening, obeying commands) | the period of time (minutes) starting from neuromuscular reversal until endotracheal extubation. estimated period of time 15 minutes | 
| Time to achievement of phase II recovery criteria | Time to achievement of post anesthesia discharge scoring system (PADSS) for determining home readiness ≥ 9. PADSS (0-10). higher score is better score | the period of time (hours) starting from endotracheal extubation to achievement of post anesthesia discharge scoring system (PADSS) for determining home readiness ≥ 9. estimated period of time 48 hours | 
| incidence of persistant coughing or agitation on emergence from GA | persistant coughing due to tracheal irritation by endotracheal tube (ETT), agitation is defined as RSS=1 | occuring after neuromuscular reversal up to 20 mins after extubation | 
| patient's rating of perioperative satisfaction | measured on a scale from 1 to 10. higher score is better score | immediately before hospital discharge (after the 1st postoperative 24- 48 hrs) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
enhanced recovery, epidural anesthesia, tolerable endotracheal tube, general anesthesia, laminectomy