Skip to main content
OpenTrials
Completed

NCT Number: NCT04596774

The Impact of Enhanced Recovery After Surgery in Orthognathic Surgery

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Traditional approach

Procedure

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

Enhanced Recovery After Surgery (ERAS) Approach

Procedure

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.

Primary outcomes

  1. Length of hospital stay

    Time frame: 0-48 hours

    Post Anaesthetic Discharge Scoring System (PADSS) (≥9/10)

Secondary outcomes

  1. Mean arterial pressure (MAP)

    Time frame: 0-5 hours

    Intraoperative follow-up

  2. Heart rate

    Time frame: 0-5 hours

    Intraoperative follow-up

  3. Intraoperative fentanyl requirement

    Time frame: 0-5 hours

    Intraoperative follow-up

  4. The amount of blood loss

    Time frame: 0-5 hours

    Intraoperative follow-up (aspirator and gases)

  5. The difference of preoperative-postoperative haemoglobin values

    Time frame: 0-12 hours

    Preop Hb-Postop Hb

  6. Length of stay in postoanesthesia care unit (PACU)

    Time frame: 0-1 hours

    Modified Aldrete Scoring system (≥9/10)

  7. Pain (Numeric rating scale (NRS)) scores

    Time frame: 0-48 hours

    Postoperative Numeric rating scale (NRS) pain scores (0: no pain, 10: worst pain imaginable)

  8. Opioid (meperidine) consumption

    Time frame: 0-48 hours

    Amount of opioid administered to the patient through the postoperative first 48 hours (Group 1: NRS≥4, Group 2: Patient controlled analgesia system)

  9. Incidence of postoperative nausea and vomiting (PONV)

    Time frame: 0-48 hours

    Number of feeling nausea or vomiting (on postoperative days 1 and 2)

  10. Postoperative first oral intake

    Time frame: 0-24 hours

    First oral liquid (water) intake time (postoperatively as soon as possible)

  11. Postoperative first passage of flatus or stool

    Time frame: 0-24 hours

    First passage of flatus or stool (postoperatively as soon as possible)

  12. Postoperative first mobilization

    Time frame: 0-24 hours

    First mobilization time (standing up-walking for any reason) (postoperatively as soon as possible)

  13. Patient satisfaction

    Time frame: 0-48 hours

    Satisfaction score: 0: very unsatisfied, 3: very satisfied

  14. Surgeon satisfaction

    Time frame: 0-48 hours

    Satisfaction score: 0: very unsatisfied, 3: very satisfied

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 22, 2020
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.