Clinical trial NCT04596774: The Impact of Enhanced Recovery After Surgery in Orthognathic Surgery
Official title: The Impact of Using Enhanced Recovery After Surgery Approach on Orthognathic Surgery Outcome: A Historical Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Enhanced Recovery After Surgery
Hospital Stay
Postoperative Nausea and Vomiting
Pain, Postoperative
Keywords: Orthognathic surgery
Enhanced recovery after surgery (ERAS)
Analgesia
Postoperative nausea vomiting (PONV)
Satisfaction
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2020-10-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
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

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.

Eligibility 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

Primary outcomes:
measure: Length of hospital stay
timeFrame: 0-48 hours
Secondary outcomes:
measure: Mean arterial pressure (MAP)
timeFrame: 0-5 hours
measure: Heart rate
timeFrame: 0-5 hours
measure: Intraoperative fentanyl requirement
timeFrame: 0-5 hours
measure: The amount of blood loss
timeFrame: 0-5 hours
measure: The difference of preoperative-postoperative haemoglobin values
timeFrame: 0-12 hours
measure: Length of stay in postoanesthesia care unit (PACU)
timeFrame: 0-1 hours
measure: Pain (Numeric rating scale (NRS)) scores
timeFrame: 0-48 hours
measure: Opioid (meperidine) consumption
timeFrame: 0-48 hours
measure: Incidence of postoperative nausea and vomiting (PONV)
timeFrame: 0-48 hours
measure: Postoperative first oral intake
timeFrame: 0-24 hours
measure: Postoperative first passage of flatus or stool
timeFrame: 0-24 hours
measure: Postoperative first mobilization
timeFrame: 0-24 hours
measure: Patient satisfaction
timeFrame: 0-48 hours
measure: Surgeon satisfaction
timeFrame: 0-48 hours
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University, Istanbul Faculty of Medicine
Study officials:
affiliation: Study Principal Investigator, Corresponding author
name: Emine A Salviz, MD,AssocProf
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.