Enhanced Recovery After Lumber Laminectomy Using Epidural and General Anesthesia

NCT ID: NCT04981158

Last Updated: 2023-08-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-15
• Study Completion Date: 2018-04-20

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.

Conditions

Postoperative Recovery; Epidural Blockade; Endotracheal Tube; Laminectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

control group, group I

standard general anesthetic (GA) technique

Group Type: PLACEBO_COMPARATOR

standard general anesthetic technique, control group, group I

Intervention Type: PROCEDURE

patients will undergo standard general anesthesia with classic endotracheal tube

Epidural /GA using TET group, group II

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)

Group Type: ACTIVE_COMPARATOR

(Epidural /GA using tolerable endotracheal tube (TET) group, group II

Intervention Type: 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.

Interventions

(Epidural /GA using tolerable endotracheal tube (TET) group, group II

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.

Intervention Type: PROCEDURE

standard general anesthetic technique, control group, group I

patients will undergo standard general anesthesia with classic endotracheal tube

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Abeer M Elnakera, MD

principle investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

tarek Y Gaafar, MD

Role: STUDY_CHAIR

Zagazig University

abeer M elnakera, MD

Role: PRINCIPAL_INVESTIGATOR

Zagazig University

abeer H alsawy

Role: STUDY_DIRECTOR

Zagazig University

Locations

Zagazig University Hospitals

Zagazig, Outside US, Egypt

Countries

Egypt

Other Identifiers

ZU-IRB #3225-18-12-2016

Identifier Type: -

Identifier Source: org_study_id