The Impact of Enhanced Recovery After Surgery in Orthognathic Surgery

Sponsor

Istanbul University (Other)

Overall Status

Completed

CT.gov ID

NCT04596774

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Enhanced Recovery After Surgery Hospital Stay Postoperative Nausea and Vomiting Pain, Postoperative	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 Design

Study Type:

Observational

Actual Enrollment :

90 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Aug 1, 2018

Actual Primary Completion Date :

Aug 30, 2020

Actual Study Completion Date :

Aug 30, 2020

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Length of hospital stay [0-48 hours]
Post Anaesthetic Discharge Scoring System (PADSS) (≥9/10)

Secondary Outcome Measures

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