Clinical trial NCT04981158: Enhanced Recovery After Lumber Laminectomy Using Epidural and General Anesthesia
Official title: Enhanced Recovery After Lumber Laminectomy Using Combined Epidural and General Anesthesia With Tolerable Endotracheal Tube
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Recovery
Epidural Blockade
Endotracheal Tube
Laminectomy
Keywords: enhanced recovery
epidural anesthesia
tolerable endotracheal tube
general anesthesia
laminectomy
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2021-07-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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:

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.

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.

Primary outcomes:
measure: Time to achievement of phase I recovery criteria
timeFrame: the period of time (mins) starting from extubation to achievement of modified Aldrete score ≥ 9. estimated period of time 30 minutes
measure: incidence of successful PACU bypass
timeFrame: immediately before postoperative patient transfer out from the operating room
Secondary outcomes:
measure: Time to extubation
timeFrame: the period of time (minutes) starting from neuromuscular reversal until endotracheal extubation. estimated period of time 15 minutes
measure: Time to achievement of phase II recovery criteria
timeFrame: 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
measure: incidence of persistant coughing or agitation on emergence from GA
timeFrame: occuring after neuromuscular reversal up to 20 mins after extubation
measure: patient's rating of perioperative satisfaction
timeFrame: immediately before hospital discharge (after the 1st postoperative 24- 48 hrs)
Other outcomes:
measure: Time to 1st postoperative rescue analgesia
timeFrame: period of time (minutes) from extubation time to 1st diclofenac administration. estimated period is the 1st postoperative 6 hours
measure: Total postoperative rescue analgesic doses required to maintain VAS for pain less than 4
timeFrame: Total postoperative rescue nalbufen (mg)) requirements for 1st postoperative 24hrs
measure: incidence of intraoperative complications
timeFrame: during operative period (from anesthetic induction to tracheal extubation. estimated time 2 hours
measure: incidence of postoperative complications
timeFrame: from extubation to home discharge. estimated time 48 hrs
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University Hospitals
state: Outside US
Study officials:
affiliation: Zagazig University
name: tarek Y Gaafar, MD
role: STUDY_CHAIR
affiliation: Zagazig University
name: abeer M elnakera, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zagazig University
name: abeer H alsawy
role: STUDY_DIRECTOR
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