Comparison of the Effects of Fentanyl, Oxycodone, Butorphanol on Gastrointestinal Function

April 21, 2020 updated by: Shijiang Liu, The First Affiliated Hospital with Nanjing Medical University

Comparison of the Effects of Fentanyl, Oxycodone, Butorphanol on Gastrointestinal Function in Patients Undergoing Laparoscopic Hysterectomy: a Double-blind, a Randomized Controlled Trial

Postoperative ileus (POI) is a transient loss of coordinated peristalsis precipitated by surgery and exacerbated by opioid pain medication.So,how to provide patients with ideal analgesia without affecting the recovery of postoperative gastrointestinal function?This was a prospective randomized controlled study. A total of 105 patients who were scheduled for laparoscopic hysterectomy were randomly selected from The First Affiliated Hospital with Nanjing Medical University by random number table. These patients were randomly divided into three groups: fentanyl(F) group, oxycodone(O) group and butorphanol(B) group.

Study Overview

Detailed Description

Background: Patients often experience pain after gynecological laparoscopy. However, the use of opioid analgesia after surgery may increase the incidence of postoperative ileus (POI). Postoperative ileus (POI) is a common surgical emergency after a surgical procedure, leading to infection and intestinal adhesions, which can extend hospitalization and increase readmission rates, and consequently increasing healthcare costs. How to provide patients with ideal analgesia without affecting the recovery of postoperative gastrointestinal function? There is no guideline which has been troubling clinical anesthesiologists.

Aims: To observe the effects of fentanyl, oxycodone, Butorphanol on the recovery of gastrointestinal function after laparoscopic hysterectomy.

Methods: A total of 105 patients undergoing laparoscopic hysterectomy were randomly divided to three groups: fentanyl group(group F), butorphanol group(group B), or oxycodone group(group O). The primary outcome measures were postoperative time to first anal exhaust the total analgesic doses in PCIA,effective bolus times. Patients were also assessed for pain with a visual analogue scale (VAS), the cumulative PCIA dose, adverse effects (Nausea,vomiting, bradycardia, respiratory depression and pruritus), sedation level at 4, 12, 24, and 48 hours postoperatively, and satisfaction during the postoperative 48 hours and postoperative hospitalization days.

Study Type

Interventional

Enrollment (Anticipated)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • The First Affiliated Hospital with Nanjing Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. patients who were scheduled for laparoscopic hysterectomy from W&C BRANCH HOSPITAL OF JIANGSU PROVINCE HOSPITAL
  2. American Society of Anesthesiologists (ASA) physical status classification 1 to 2,
  3. Women aged 40-65
  4. Weight 50-80 kg

Exclusion Criteria:

  1. History of opioids abuse and allergy and contraindication to opioid drugs
  2. bronchial asthma; coronary heart disease; severe hypertension; diabetes mellitus;
  3. hepatic, and renal dysfunction (glutamyl aminotransferase> 40U or aspartate aminotransferase> 35U; urea nitrogen> 8.2 μmol / L, creatinine> 133 μmol / L),
  4. History of brain damage or psychiatric disease
  5. Patients with coagulopathy (PT> 17 seconds or activated partial thromboplastin time (APTT)> 47 seconds);
  6. pregnant or lactating women;
  7. Those with long-term constipation;
  8. History of digestive diseases;
  9. history of gastrointestinal disease (peptic ulcer disease, Crohn's disease, or ulcerative colitis)
  10. Participants in other drug trials in the past three months. (11)After randomization and allocation, patients were withdrawn if laparoscopy was converted to open surgery or if they required reinvestigation for postoperative bleeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Fentanyl group(group F)
Fentanyl citrate injection, specification: 10mL: 0.5mg / piece (production unit: niching chang rendu Pharmaceutical Co., Ltd., valid period: 48 months) For group F patients,0.5mg fentanyl was mixed with saline to a total volume of 100mL; continuous infusion was set to 2mL/h, a bolus dose of 3mL, and a lockout interval of 15 minutes
At present, opioids are most widely used in postoperative analgesia. This study aims to use different opioid receptor agonists---fentanyl, oxycodone and butorphanol for analgesia after laparoscopic hysterectomy.Compare the recovery of gastrointestinal function after operation.
Other Names:
  • intravenous patient-controlled analgesia (IV-PCA)
Experimental: Oxycodone group(group O)
Oxycodone hydrochloride injection, specification: 1mL: 10mg / branch (production unit: HAMOL LIMITED, valid period: 60 months) For group O patients,30mg oxycodone was mixed with saline to a total volume of 100mL; continuous infusion was set to 2mL/h, a bolus dose of 3mL, and a lockout interval of 15 minutes
At present, opioids are most widely used in postoperative analgesia. This study aims to use different opioid receptor agonists---fentanyl, oxycodone and butorphanol for analgesia after laparoscopic hysterectomy.Compare the recovery of gastrointestinal function after operation.
Other Names:
  • intravenous patient-controlled analgesia (IV-PCA)
Experimental: Butorphanol group(group B)
Butorphanol tartrate injection, specification: 1 mL: 1 mg / branch (production unit: Jiangsu henryi Pharmaceutical Co., Ltd., valid period: 24 months); For group B patients,10mg butorphanol was mixed with saline to a total volume of 100mL; continuous infusion was set to 2mL/h, a bolus dose of 3mL, and a lockout interval of 15 minutes
At present, opioids are most widely used in postoperative analgesia. This study aims to use different opioid receptor agonists---fentanyl, oxycodone and butorphanol for analgesia after laparoscopic hysterectomy.Compare the recovery of gastrointestinal function after operation.
Other Names:
  • intravenous patient-controlled analgesia (IV-PCA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative time to first anal exhaust
Time Frame: From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 15 days
Timing from the end of the operation
From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 15 days
the cumulative dose administered in the patient-controlled mode
Time Frame: From date of operation until the date of first documented progression of anal exhaust , assessed up to 48 hours
The cumulative dose administered in the patient-controlled mode during the initial 48 hours after the operation was measured
From date of operation until the date of first documented progression of anal exhaust , assessed up to 48 hours
effective bolus times
Time Frame: From date of operation until the date of first documented progression of anal exhaust , assessed up to 48 hours
The effective bolus times in the patient-controlled mode during the initial 48 hours after the operation was measured
From date of operation until the date of first documented progression of anal exhaust , assessed up to 48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain score
Time Frame: at 4 hours postoperatively
by using numerical rating scale (NRS):The pain scale ranged from 0 (=no pain) to 10 (=worst pain imaginable)
at 4 hours postoperatively
pain score
Time Frame: at 12 hours postoperatively
by using numerical rating scale (NRS):The pain scale ranged from 0 (=no pain) to 10 (=worst pain imaginable)
at 12 hours postoperatively
pain score
Time Frame: at 24 hours postoperatively
by using numerical rating scale (NRS):The pain scale ranged from 0 (=no pain) to 10 (=worst pain imaginable)
at 24 hours postoperatively
pain score
Time Frame: at 48 hours postoperatively
by using numerical rating scale (NRS):The pain scale ranged from 0 (=no pain) to 10 (=worst pain imaginable)
at 48 hours postoperatively
Sedation score
Time Frame: at 4 hours postoperatively
by using Ramsay scale(1=anxious and agitated or restless, or both; 2=cooperative, oriented, and tranquil; 3=responds to command only; 4=asleep, but has a brisk response to light tactile stimulus or a simple verbal command; 5=asleep, but arousable only by strong physical stimulus; and 6=asleep, unarousable)
at 4 hours postoperatively
Sedation score
Time Frame: at 12 hours postoperatively
by using Ramsay scale(1=anxious and agitated or restless, or both; 2=cooperative, oriented, and tranquil; 3=responds to command only; 4=asleep, but has a brisk response to light tactile stimulus or a simple verbal command; 5=asleep, but arousable only by strong physical stimulus; and 6=asleep, unarousable)
at 12 hours postoperatively
Sedation score
Time Frame: at 24 hours postoperatively
by using Ramsay scale(1=anxious and agitated or restless, or both; 2=cooperative, oriented, and tranquil; 3=responds to command only; 4=asleep, but has a brisk response to light tactile stimulus or a simple verbal command; 5=asleep, but arousable only by strong physical stimulus; and 6=asleep, unarousable)
at 24 hours postoperatively
Sedation score
Time Frame: at 48 hours postoperatively
by using Ramsay scale(1=anxious and agitated or restless, or both; 2=cooperative, oriented, and tranquil; 3=responds to command only; 4=asleep, but has a brisk response to light tactile stimulus or a simple verbal command; 5=asleep, but arousable only by strong physical stimulus; and 6=asleep, unarousable)
at 48 hours postoperatively
adverse effects
Time Frame: at 4 hours postoperatively
Nausea 、vomiting 、bradycardia(HR <60 beats min-1)、respiratory depression(According to practice guidelines from the ASA, clinical signs of opioid-induced respiratory depression are respiratory rate <10 bpm, arterial O2 saturation <90%, or arterial CO2 tension >6.66 kPa) and pruritus
at 4 hours postoperatively
adverse effects
Time Frame: at 12 hours postoperatively
Nausea 、vomiting 、bradycardia(HR <60 beats min-1)、respiratory depression(According to practice guidelines from the ASA, clinical signs of opioid-induced respiratory depression are respiratory rate <10 bpm, arterial O2 saturation <90%, or arterial carbon dioxide (CO2)tension >6.66 kPa) and pruritus
at 12 hours postoperatively
adverse effects
Time Frame: at 24 hours postoperatively
Nausea 、vomiting 、bradycardia(HR <60 beats min-1)、respiratory depression (According to practice guidelines from the ASA, clinical signs of opioid-induced respiratory depression are respiratory rate <10 bpm, arterial O2 saturation <90%, or arterial CO2 tension >6.66 kPa)and pruritus
at 24 hours postoperatively
adverse effects
Time Frame: at 48 hours postoperatively
Nausea 、vomiting 、bradycardia(HR <60 beats min-1)、respiratory depression (According to practice guidelines from the ASA, clinical signs of opioid-induced respiratory depression are respiratory rate <10 bpm, arterial O2 saturation <90%, or arterial CO2 tension >6.66 kPa)and pruritus
at 48 hours postoperatively
patients' degree of overall satisfaction with the postoperative analgesia
Time Frame: at 48 hours postoperatively
Patients were asked to evaluate their degree of overall satisfaction with the postoperative analgesia on a 11-point scale (0= very unsatisfied, 1-3= unsatisfied, 4-6 = neutral, 7-9= satisfied, or 10 = very satisfied).
at 48 hours postoperatively
postoperative hospitalization days
Time Frame: From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 15 days
All patients were cured in accordance with clinical cure standard
From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Cunming Liu, doctorate, The First Affiliated Hospital with Nanjing Medical University
  • Study Chair: Shijiang Liu, Master, The First Affiliated Hospital with Nanjing Medical University
  • Study Director: Chuanbao Han, The First Affiliated Hospital with Nanjing Medical University
  • Study Chair: Minna Guo, The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2020

Primary Completion (Anticipated)

July 31, 2020

Study Completion (Anticipated)

July 31, 2020

Study Registration Dates

First Submitted

January 5, 2020

First Submitted That Met QC Criteria

March 2, 2020

First Posted (Actual)

March 4, 2020

Study Record Updates

Last Update Posted (Actual)

April 24, 2020

Last Update Submitted That Met QC Criteria

April 21, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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