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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control group, group I | Placebo Comparator | standard general anesthetic (GA) technique |
|
| Epidural /GA using TET group, group II | Active Comparator | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (Epidural /GA using tolerable endotracheal tube (TET) group, group II | Procedure | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to 1st postoperative rescue analgesia | time to 1st achievement of moderate to severe pain visual analogue score for pain (VAS)≥ 0.4. VAS for pain (0- 10). lower scores indicate better pain control | period of time (minutes) from extubation time to 1st diclofenac administration. estimated period is the 1st postoperative 6 hours |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| tarek Y Gaafar, MD | Zagazig University | Study Chair |
| abeer M elnakera, MD | Zagazig University | Principal Investigator |
| abeer H alsawy | Zagazig University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zagazig University Hospitals | Zagazig | Outside US | 44111 | Egypt |
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|
| standard general anesthetic technique, control group, group I | Procedure | patients will undergo standard general anesthesia with classic endotracheal tube |
|
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) |
| Total postoperative rescue analgesic doses required to maintain VAS for pain less than 4 |
Total postoperative rescue nalbufen (mg)) requirements |
| Total postoperative rescue nalbufen (mg)) requirements for 1st postoperative 24hrs |
| incidence of intraoperative complications | number of patients who will suffer either intraoperative hypotension or bradycardia | during operative period (from anesthetic induction to tracheal extubation. estimated time 2 hours |
| incidence of postoperative complications | number of patients who will suffer postoperative hypotension, bradycardia, excessive sedation (RSS RSS≥ 5), new neurological deficit, postoperative nausea and vomiting (PONV) or urine retention | from extubation to home discharge. estimated time 48 hrs |
| ID | Term |
|---|---|
| D007268 | Injections, Epidural |
| D044382 | Population Groups |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D007278 | Injections, Spinal |
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D003710 | Demography |
| D011154 | Population Characteristics |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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