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Clinical Trials/NCT04048070
NCT04048070
Completed
Not Applicable

Benefits of Enhanced Recovery After Surgery in Patients Undergoing Endoscopic Sinus Surgery

Beijing Tongren Hospital1 site in 1 country55 target enrollmentMay 3, 2018

Overview

Phase
Not Applicable
Intervention
Flurbiprofen Axetil
Conditions
Chronic Rhinosinusitis (Diagnosis)
Sponsor
Beijing Tongren Hospital
Enrollment
55
Locations
1
Primary Endpoint
Pain management
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

Enhanced recovery after surgery (ERAS) protocols have been widely applied during perioperative periods for different diseases, there are few reports of ERAS in patients undergoing endoscopic sinus surgery (ESS). This study therefore aimed to evaluate the benefits of ERAS protocol compared to traditional care following ESS.

Registry
clinicaltrials.gov
Start Date
May 3, 2018
End Date
October 30, 2018
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Beijing Tongren Hospital
Responsible Party
Principal Investigator
Principal Investigator

Luo Zhang

vise president of BeijingTongren Hospital

Beijing Tongren Hospital

Eligibility Criteria

Inclusion Criteria

  • The patient has CRSwNP need endoscopic sinus surgery for treatment.

Exclusion Criteria

  • age under 18 years
  • ASA grade IV
  • received oral or topical steroids within 4 weeks preceding surgery
  • had previous ESS history
  • intolerant to NSAIDS
  • comorbidity of severe mental disease
  • not compliant with therapy.

Arms & Interventions

ERAS with postoperative intravenous Flubiprofen Axetil

The patients was given extended perioperative counseling, shorter fasting food for 6 to 8 hours and carbohydrate water for 2 hours before surgery. Early ambulation and oral intake 2 hours after patient recovery from anesthesia. Once a day 100mg Flubiprofen Axetil in this group for postoperative pain management.

Intervention: Flurbiprofen Axetil

ERAS with postoperative intravenous Flubiprofen Axetil

The patients was given extended perioperative counseling, shorter fasting food for 6 to 8 hours and carbohydrate water for 2 hours before surgery. Early ambulation and oral intake 2 hours after patient recovery from anesthesia. Once a day 100mg Flubiprofen Axetil in this group for postoperative pain management.

Intervention: Extended perioperative counseling

ERAS with postoperative intravenous Flubiprofen Axetil

The patients was given extended perioperative counseling, shorter fasting food for 6 to 8 hours and carbohydrate water for 2 hours before surgery. Early ambulation and oral intake 2 hours after patient recovery from anesthesia. Once a day 100mg Flubiprofen Axetil in this group for postoperative pain management.

Intervention: Shorter fasting food and water time before surgery

ERAS with analgesia pump

The patients was given extended perioperative counseling, shorter fasting food for 6 to 8 hours and carbohydrate water for 2 hours before surgery. Early ambulation and oral intake 2 hours after patient recovery from anesthesia. An electronic analgesic pump containing opioids drug and Flubiprofen Axetil in this group for postoperative pain management.

Intervention: Sufentanil

ERAS with analgesia pump

The patients was given extended perioperative counseling, shorter fasting food for 6 to 8 hours and carbohydrate water for 2 hours before surgery. Early ambulation and oral intake 2 hours after patient recovery from anesthesia. An electronic analgesic pump containing opioids drug and Flubiprofen Axetil in this group for postoperative pain management.

Intervention: Extended perioperative counseling

ERAS with analgesia pump

The patients was given extended perioperative counseling, shorter fasting food for 6 to 8 hours and carbohydrate water for 2 hours before surgery. Early ambulation and oral intake 2 hours after patient recovery from anesthesia. An electronic analgesic pump containing opioids drug and Flubiprofen Axetil in this group for postoperative pain management.

Intervention: Shorter fasting food and water time before surgery

Traditional care with Flubiprofen Axetil

Conventional perioperative counseling and regular fasting food for 12 hours and water for 6 hours before surgery. Lie down and oral intake at least 4 hours after recovery. Once a day 100mg Flubiprofen Axetil in this group for postoperative pain management.

Intervention: Flurbiprofen Axetil

Traditional care with Flubiprofen Axetil

Conventional perioperative counseling and regular fasting food for 12 hours and water for 6 hours before surgery. Lie down and oral intake at least 4 hours after recovery. Once a day 100mg Flubiprofen Axetil in this group for postoperative pain management.

Intervention: Conventional perioperative counseling

Traditional care with Flubiprofen Axetil

Conventional perioperative counseling and regular fasting food for 12 hours and water for 6 hours before surgery. Lie down and oral intake at least 4 hours after recovery. Once a day 100mg Flubiprofen Axetil in this group for postoperative pain management.

Intervention: Regular fasting food and water time before surgery

Traditional care with analgesia pump

Conventional perioperative counseling and regular fasting food for 12 hours and water for 6 hours before surgery. Lie down and oral intake at least 4 hours after recovery. An electronic analgesic pump containing opioids drug and Flubiprofen Axetil in this group for postoperative pain management.

Intervention: Sufentanil

Traditional care with analgesia pump

Conventional perioperative counseling and regular fasting food for 12 hours and water for 6 hours before surgery. Lie down and oral intake at least 4 hours after recovery. An electronic analgesic pump containing opioids drug and Flubiprofen Axetil in this group for postoperative pain management.

Intervention: Conventional perioperative counseling

Traditional care with analgesia pump

Conventional perioperative counseling and regular fasting food for 12 hours and water for 6 hours before surgery. Lie down and oral intake at least 4 hours after recovery. An electronic analgesic pump containing opioids drug and Flubiprofen Axetil in this group for postoperative pain management.

Intervention: Regular fasting food and water time before surgery

traditional care without postoperative intravenous analgesia.

Conventional perioperative counseling and regular fasting food for 12 hours and water for 6 hours before surgery. Lie down and oral intake at least 4 hours after recovery. Intravenous saline with necessary oral analgesic for postoperative pain management.

Intervention: Conventional perioperative counseling

traditional care without postoperative intravenous analgesia.

Conventional perioperative counseling and regular fasting food for 12 hours and water for 6 hours before surgery. Lie down and oral intake at least 4 hours after recovery. Intravenous saline with necessary oral analgesic for postoperative pain management.

Intervention: Regular fasting food and water time before surgery

Outcomes

Primary Outcomes

Pain management

Time Frame: at 48 hours after surgery

The pain scores after surgery were scored on a visual analogue scale of 0 to 10 as previously described, with 0 being no complaints whatsoever and 10 being the worst imaginable.

Secondary Outcomes

  • Hunger scores(at 5 minutes before surgery start)
  • Self-rating Anxiety Scale(at baseline and 72 hours after surgery)
  • thirst scores(at 5 minutes before surgery start)
  • General comfort scores(at baseline and 72 hours after surgery)
  • quality of sleeping(at baseline and 72 hours after surgery)

Study Sites (1)

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