Enhanced Recovery After Lumber Laminectomy Using Epidural and General Anesthesia

NCT04981158 | Completed

• 1 other identifier: ZU-IRB #3225-18-12-2016
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Recovery; Epidural Blockade; Endotracheal Tube; Laminectomy

Keywords

enhanced recovery; epidural anesthesia; tolerable endotracheal tube; general anesthesia; laminectomy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Time to extubation

  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

  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

  occuring after neuromuscular reversal up to 20 mins after extubation

• patient's rating of perioperative satisfaction

  immediately before hospital discharge (after the 1st postoperative 24- 48 hrs)

Other Outcomes (4)

• Time to 1st postoperative rescue analgesia

  period of time (minutes) from extubation time to 1st diclofenac administration. estimated period is the 1st postoperative 6 hours

• Total postoperative rescue analgesic doses required to maintain VAS for pain less than 4

  Total postoperative rescue nalbufen (mg)) requirements for 1st postoperative 24hrs

• incidence of intraoperative complications

  during operative period (from anesthetic induction to tracheal extubation. estimated time 2 hours

Study Arms (2)

control group, group I

PLACEBO COMPARATOR

standard general anesthetic (GA) technique

Procedure: standard general anesthetic technique, control group, group I

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)

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

Interventions

(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.

Epidural /GA using TET group, group II

standard general anesthetic technique, control group, group I PROCEDURE

patients will undergo standard general anesthesia with classic endotracheal tube

control group, group I

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

Zagazig University Hospitals

Zagazig, Outside US, 44111, Egypt

Location

MeSH Terms

Interventions

Injections, Epidural; Population Groups; Control Groups

Intervention Hierarchy (Ancestors)

Injections, Spinal; Injections; Drug Administration Routes; Drug Therapy; Therapeutics; Demography; Population Characteristics; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• tarek Y Gaafar, MD

  Zagazig University

  STUDY CHAIR

• abeer M elnakera, MD

  Zagazig University

  PRINCIPAL INVESTIGATOR

• abeer H alsawy

  Zagazig University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: June 26, 2021
• First Posted: July 28, 2021
• Study Start: January 15, 2017
• Primary Completion: December 12, 2017
• Study Completion: April 20, 2018
• Last Updated: August 18, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)