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

NCT ID: NCT04295109

Last Updated: 2020-04-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-02
• Study Completion Date: 2020-07-31

Brief Summary

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.

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.

Conditions

Cervix Neoplasms; Endometrial Cancer; Adenomyosis; Fibroid Uterus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

the drug of intravenous patient-controlled analgesia

Intervention Type: DRUG

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.

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

Group Type: EXPERIMENTAL

the drug of intravenous patient-controlled analgesia

Intervention Type: DRUG

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.

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

Group Type: EXPERIMENTAL

the drug of intravenous patient-controlled analgesia

Intervention Type: DRUG

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.

Interventions

the drug of intravenous patient-controlled analgesia

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.

Intervention Type: DRUG

Other Intervention Names

intravenous patient-controlled analgesia (IV-PCA)

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Shijiang Liu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cunming Liu, doctorate

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Shijiang Liu, Master

Role: STUDY_CHAIR

The First Affiliated Hospital with Nanjing Medical University

Chuanbao Han

Role: STUDY_DIRECTOR

The First Affiliated Hospital with Nanjing Medical University

Minna Guo

Role: STUDY_CHAIR

The First Affiliated Hospital with Nanjing Medical University

Locations

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

Cunming Liu, doctorate

Role: CONTACT

1335587409@qq.com

13951890866

Minna Guo, Master

Role: CONTACT

1653474602@qq.com

18835162576

Facility Contacts

Cunming Liu

Role: primary

1335587409@qq.com

13951890866

Minna Guo

Role: backup

1653474602@qq.com

18835162576

References

Guo M, Liu S, Gao J, Han C, Yang C, Liu C. The effects of fentanyl, oxycodone, and butorphanol on gastrointestinal function in patients undergoing laparoscopic hysterectomy: a prospective, double-blind, randomized controlled trial. BMC Anesthesiol. 2022 Feb 24;22(1):53. doi: 10.1186/s12871-022-01594-9.

Reference Type: DERIVED

PMID: 35209847 (View on PubMed)

Other Identifiers

2019-SR-476

Identifier Type: -

Identifier Source: org_study_id