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The Impact of Enhanced Recovery After Surgery in Orthognathic Surgery

The Impact of Using Enhanced Recovery After Surgery Approach on Orthognathic Surgery Outcome: A Historical Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04596774
Enrollment
90
Registered
2020-10-22
Start date
2018-08-01
Completion date
2020-08-30
Last updated
2020-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Enhanced Recovery After Surgery, Hospital Stay, Pain, Postoperative, Postoperative Nausea and Vomiting

Keywords

Orthognathic surgery, Enhanced recovery after surgery (ERAS), Analgesia, Postoperative nausea vomiting (PONV), Satisfaction

Brief summary

Aim: Orthognathic surgeries are generally associated with blood loss, swelling, postoperative nausea vomiting (PONV), and pain. The aim of this study is to improve postoperative outcome in patients undergoing orthognatic surgeries by the use of Enhanced Recovery After Surgery (ERAS) protocols. Material methods: After Ethics Committee approval (2020/965), the data of 90 patients who underwent elective orthognathic surgery, were investigated. Following standard monitorization and general anesthesia; Group 1 patients were applied traditional approach and received intraoperative 10 mL/kg/h IV izolen infusion. Group 2 received ERAS approach. Patients in Group 2 did not preoperatively smoke for 48 hours, drank clear liquids until the last 2 hours, and received 6 mL/kg/h IV izolen intraoperatively. In these; gastric aspiration was also applied before extubation, PONV prophylaxis and patient controlled analgesia was added to the routine plans for the first postoperative 48 hours. The primary endpoint was length of hospital stay. The secondary endpoints were intraoperative follow-up data, length of postanesthesia care unit (PACU) stay, numeric rating scale (NRS) pain scores, opioid consumption and PONV incidences through the postoperative first 48 hours, and satisfaction scores.

Detailed description

Aim: Orthognathic surgeries are extensive surgeries including both soft and hard tissues of the facial region of the skull associated with blood loss, inflammatory reactions, massive swelling, postoperative nausea vomiting (PONV), and severe pain. Therefore; in most of the patients who are with dentofacial deformity and undergo orthognathic surgery, postoperative recovery generally requires a long troublesome period. The aim of this study is to improve postoperative outcome by the use of Enhanced Recovery After Surgery (ERAS) protocols. Material methods: After Ethics Committee approval (2020/965), the data of 90 patients who underwent elective orthognathic surgery, were investigated. Following standard monitorization and general anesthesia; Group 1 patients were applied traditional approach and received intraoperative 10 mL/kg/h IV izolen infusion. Rescue analgesics and PONV prophylaxis were applied when required through the postoperative first 48 hours. Group 2 received ERAS approach. Patients in Group 2 did not preoperatively smoke for 48 hours, drank clear liquids until the last 2 hours, and received 6 mL/kg/h IV izolen infusion intraoperatively. In these; gastric aspiration was also applied before extubation, PONV prophylaxis was supported routinely, and patient controlled analgesia was added to the routine analgesia plan for the first postoperative 48 hours. The primary endpoint was length of hospital stay. The secondary endpoints were intraoperative follow-up data, numeric rating scale (NRS) pain scores, opioid consumption, PONV incidences, length of postanesthesia care unit (PACU) stay, satisfaction scores of two groups through the postoperative first 48 hours.

Interventions

Patients received intraoperative 10 mL/kg/h IV izolen infusion. Opioids and PONV prophylaxis were applied when required.

PROCEDUREEnhanced Recovery After Surgery (ERAS) Approach

Patients did not preoperatively smoke for 48 hours, drank clear liquids until the last 2 hours and received 6 mL/kg/h IV izolen infusion intraoperatively. In these; gastric aspiration was applied before extubation, PONV prophylaxis was supported routinely, and patient controlled analgesia was added to the routine analgesia plan for the first postoperative 48 hours.

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

Inclusion criteria

* Patients undergoing orthognathic surgery (bimaxillary, mandibular/maxillary) * Patients aged between 18 and 40 years of age * American Society of Anesthesiologists (ASA) physical status of 1-2 * Capable of understanding the instructions for using the NRS pain scores * Capable of replying the study-based questions * Absence of mental/psychiatric disorders * Absence of chronic analgesic/opioid use * Absence of alcohol/illicit drug use

Exclusion criteria

* Patients who are younger than 18 years of age * Patients who are older than 45 years of age * American Society of Anesthesiologists (ASA) physical status of 3-4 * Not capable of consenting * Not capable of understanding the instructions for using the NRS pain * scores * Not capable of replying the study-based questions * Presence of mental/psychiatric disorders * Presence of chronic analgesic/opioid use * Presence of alcohol/illicit drug use

Design outcomes

Primary

MeasureTime frameDescription
Length of hospital stay0-48 hoursPost Anaesthetic Discharge Scoring System (PADSS) (≥9/10)

Secondary

MeasureTime frameDescription
Intraoperative fentanyl requirement0-5 hoursIntraoperative follow-up
Length of stay in postoanesthesia care unit (PACU)0-1 hoursModified Aldrete Scoring system (≥9/10)
Mean arterial pressure (MAP)0-5 hoursIntraoperative follow-up
The amount of blood loss0-5 hoursIntraoperative follow-up (aspirator and gases)
The difference of preoperative-postoperative haemoglobin values0-12 hoursPreop Hb-Postop Hb
Pain (Numeric rating scale (NRS)) scores0-48 hoursPostoperative Numeric rating scale (NRS) pain scores (0: no pain, 10: worst pain imaginable)
Heart rate0-5 hoursIntraoperative follow-up
Incidence of postoperative nausea and vomiting (PONV)0-48 hoursNumber of feeling nausea or vomiting (on postoperative days 1 and 2)
Postoperative first oral intake0-24 hoursFirst oral liquid (water) intake time (postoperatively as soon as possible)
Postoperative first passage of flatus or stool0-24 hoursFirst passage of flatus or stool (postoperatively as soon as possible)
Postoperative first mobilization0-24 hoursFirst mobilization time (standing up-walking for any reason) (postoperatively as soon as possible)
Patient satisfaction0-48 hoursSatisfaction score: 0: very unsatisfied, 3: very satisfied
Surgeon satisfaction0-48 hoursSatisfaction score: 0: very unsatisfied, 3: very satisfied
Opioid (meperidine) consumption0-48 hoursAmount of opioid administered to the patient through the postoperative first 48 hours (Group 1: NRS≥4, Group 2: Patient controlled analgesia system)

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026