The Impact of Enhanced Recovery After Surgery in Orthognathic Surgery

Istanbul University

Status: Completed

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

Treatments: Procedure: Traditional Approach; Procedure: Enhanced Recovery After Surgery (ERAS) Approach

Study type: Observational

Funder types: Other

Identifiers

NCT04596774

2020/965

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

90 participants in 2 patient groups

Group 1

Description:

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.

Treatment:

Procedure: Traditional Approach

Group 2

Description:

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.

Treatment:

Procedure: Enhanced Recovery After Surgery (ERAS) Approach