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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Postoperative Nausea and Vomiting; Enhanced Recovery After Surgery; Hospital Stay
• Intervention / Treatment: Procedure: Traditional Approach; Procedure: Enhanced Recovery After Surgery (ERAS) Approach

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.

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Turkey
  • Istanbul, Turkey, 34093
    • Istanbul University, Istanbul Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients eligible for orthognathic surgery Patients who were operated under either the traditional approach or the Enhanced Recovery After Surgery (ERAS) approach Patients aged between 18 and 40 years of age American Society of Anesthesiologists (ASA) physical status of 1-2

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group 1; Group 1 patients were applied traditional approach. Patients received intraoperative 10 mL/kg/h IV izolen infusion. Opioids and PONV prophylaxis were applied when required.	Procedure: Traditional Approach; Patients received intraoperative 10 mL/kg/h IV izolen infusion. Opioids and PONV prophylaxis were applied when required.
Group 2; Group 2 received Enhanced 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.	Procedure: Enhanced 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Post Anaesthetic Discharge Scoring System (PADSS) (≥9/10)	0-48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperative nausea and vomiting (PONV)	Number of feeling nausea or vomiting (on postoperative days 1 and 2)	0-48 hours
Patient satisfaction	Satisfaction score: 0: very unsatisfied, 3: very satisfied	0-48 hours
Surgeon satisfaction	Satisfaction score: 0: very unsatisfied, 3: very satisfied	0-48 hours
Mean arterial pressure (MAP)	Intraoperative follow-up	0-5 hours
Heart rate	Intraoperative follow-up	0-5 hours
Intraoperative fentanyl requirement	Intraoperative follow-up	0-5 hours
The amount of blood loss	Intraoperative follow-up (aspirator and gases)	0-5 hours
The difference of preoperative-postoperative haemoglobin values	Preop Hb-Postop Hb	0-12 hours
Length of stay in postoanesthesia care unit (PACU)	Modified Aldrete Scoring system (≥9/10)	0-1 hours
Pain (Numeric rating scale (NRS)) scores	Postoperative Numeric rating scale (NRS) pain scores (0: no pain, 10: worst pain imaginable)	0-48 hours
Opioid (meperidine) consumption	Amount of opioid administered to the patient through the postoperative first 48 hours (Group 1: NRS≥4, Group 2: Patient controlled analgesia system)	0-48 hours
Postoperative first oral intake	First oral liquid (water) intake time (postoperatively as soon as possible)	0-24 hours
Postoperative first passage of flatus or stool	First passage of flatus or stool (postoperatively as soon as possible)	0-24 hours
Postoperative first mobilization	First mobilization time (standing up-walking for any reason) (postoperatively as soon as possible)	0-24 hours

Collaborators and Investigators

• Sponsor: Istanbul University

Publications and helpful links

General Publications

• Dobbeleir M, De Coster J, Coucke W, Politis C. Postoperative nausea and vomiting after oral and maxillofacial surgery: a prospective study. Int J Oral Maxillofac Surg. 2018 Jun;47(6):721-725. doi: 10.1016/j.ijom.2017.11.018. Epub 2018 Jan 1.
• Lin S, McKenna SJ, Yao CF, Chen YR, Chen C. Effects of Hypotensive Anesthesia on Reducing Intraoperative Blood Loss, Duration of Operation, and Quality of Surgical Field During Orthognathic Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. J Oral Maxillofac Surg. 2017 Jan;75(1):73-86. doi: 10.1016/j.joms.2016.07.012. Epub 2016 Jul 25.
• Mobini A, Mehra P, Chigurupati R. Postoperative Pain and Opioid Analgesic Requirements After Orthognathic Surgery. J Oral Maxillofac Surg. 2018 Nov;76(11):2285-2295. doi: 10.1016/j.joms.2018.05.014. Epub 2018 May 19.
• Agbaje J, Luyten J, Politis C. Pain Complaints in Patients Undergoing Orthognathic Surgery. Pain Res Manag. 2018 Jul 15;2018:4235025. doi: 10.1155/2018/4235025. eCollection 2018.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2018
• Primary Completion (ACTUAL): August 30, 2020
• Study Completion (ACTUAL): August 30, 2020

Study Registration Dates

• First Submitted: October 18, 2020
• First Submitted That Met QC Criteria: October 18, 2020
• First Posted (ACTUAL): October 22, 2020

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 20, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Analgesia; Satisfaction; Orthognathic surgery; Enhanced recovery after surgery (ERAS); Postoperative nausea vomiting (PONV)
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Pain, Postoperative; Nausea; Vomiting; Postoperative Nausea and Vomiting
• Other Study ID Numbers: 2020/965

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No