The Impact of Enhanced Recovery After Surgery in Orthognathic Surgery

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04596774
• Other study ID #: 2020/965
• Status: Completed
• Start date: August 1, 2018
• Est. completion date: August 30, 2020

Study information

• Verified date: October 2020
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Enhanced Recovery After Surgery
• Hospital Stay
• Nausea
• Pain, Postoperative
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

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

Locations

Country	Name	City	State
Turkey	Istanbul University, Istanbul Faculty of Medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View 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. — View 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 Cont — View 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. — View Citation

Outcome

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