Clinical trial NCT04301232: Fast-Track Eligibility and Hospital Discharge for Outpatient Lumbar Discectomy
Official title: Fast-Track Eligibility and Hospital Discharge for Outpatient Lumbar Discectomy: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Disc Disease
Post-Op Complication
Keywords: PACU-bypass
hospital discharge
lumbar discectomy
Lead sponsor: Gulhane School of Medicine
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 122 ASA (American Society of Anesthesiologists) physical status I-II patients, aged between 18-65 years, undergoing elective lumbar discectomy under general anesthesia were included into the study.

Brief summary: 122 ASA I-II patients were enrolled into the study. IV propofol, fentanyl and rocuronium were used for the induction and a total intravenous anesthesia technique for the maintenance of anesthesia. Sugammadex was given for neuromuscular blockade reversal. A multi-modal analgesic regimen was utilized. Primary outcome measures were PACU bypass rates and hospital discharge times. Secondary outcome measure was to compare discharge scoring systems for PACU bypass assessment: modified Aldrete Scoring System (mASS), White's Fast-Tracking Scoring System (WFTSS), and SPEEDS criteria

Detailed description: After obtaining hospital's ethics committee approval (University of Medical Sciences, Gülhane Training and Research Hospital- Date: 06/05/2018; No: 18/148) and written informed consents obtained from patients, 122 ASA (American Society of Anesthesiologists) physical status I-II patients, aged between 18-65 years, undergoing elective lumbar discectomy under general anesthesia were included into the study . After anesthesia application applied to all groups with the same procedure, patients were extubated after surgery. After extubation, patients were evaluated using mASS, WFTSS and SPEEDS criteria during 15 minutes with 3 min intervals. Patients who fulfilled criteria of all scoring systems were defined as eligible for PACU by-pass (fast-tracking) and transferred into phase II recovery area in the ward without observation in PACU (Group FT = Fast Track;). Ineligible patients were taken into PACU where their treatments were continued until discharge criteria were achieved (Group PACU). All patients were followed in the ward until hospital discharge. IV tramadol PCA (Patient -Controlled Analgesia; infusion rate: 4 mgh-1, bolus dose: 4mg, lock-out time: 30 min., 4 hours-limit: 30 mg), paracetamol (10 mgkg-1 IV with 6 hrs. intervals) and oral diclofenac sodium (75 mg with 8 hrs. intervals) were given in a multimodal analgesic regimen. Pain was evaluated using Visual Analogue Scale (VAS) with 2 hours intervals and IV pethidine 0.5 mgkg-1 was given as rescue analgesic throughout the study period when VAS was \>3. PONV was treated using IV 4 mg ondansetron. Discharge from hospital was evaluated using Post Anesthetic Discharge Scoring System (PADSS), . Patients with a PADSS score ≥ 9 were discharged from the hospital by the escort of their relatives.

Eligibility criteria: Inclusion Criteria:

* ASA (American Society of Anesthesiologists) physical status I-II patients
* elective primary lumbar discectomy performed for one or two vertebra levels under general anesthesia
* minimal risks for perioperative bleeding and airway safety

Exclusion Criteria:

* patient's refusal
* urgent surgery,
* regional anesthesia,
* history of previous lumbar surgery
* difficult ventilation and intubation,
* treatment for chronic pain
* obstructive sleep apnea,
* morbid obesity (BMI≥40 kg/m2)
* allergy to drugs

Primary outcomes:
measure: Duration of the surgery
timeFrame: at the end of the surgery
measure: time to extubation
timeFrame: 1 hour after extubation
measure: PACU( post-anesthesia care unit) by-pass rate
timeFrame: 1 weeks after discharge from the hospital
measure: Time to hospital discharge
timeFrame: 1 weeks after discharge from the hospital
measure: Time to PACU by-pass in group FT
timeFrame: 1 weeks after discharge from the hospital
measure: time to PACU care in group PACU
timeFrame: 1 weeks after discharge from the hospital
measure: patients who were eligible for fast-tracking
timeFrame: through study completion, an average of 2 weeks
measure: patients who were discharged from hospital
timeFrame: through study completion, an average of 2 weeks
measure: factors preventing
timeFrame: through study completion, an average of 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Çankaya Hospital, Department of Anesthesiology and Reanimation, Ankara, Turkey
state: Çankaya/ANKARA
Study officials:
affiliation: Çankaya Hospital, Department of Anesthesiology and Reanimation, Ankara, Turkey
name: Mehmet Ö ÖZHAN, M.D.
role: STUDY_DIRECTOR
affiliation: Gulhane Training and Research Hospital
name: Mehmet B. EŞKİN, M.D.
role: PRINCIPAL_INVESTIGATOR
References: