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

Nanjing Medical University

Status: Unknown

Conditions: Endometrial Cancer; Cervix Neoplasms; Fibroid Uterus; Adenomyosis

Treatments: Drug: the drug of intravenous patient-controlled analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT04295109

2019-SR-476

Details and patient eligibility

About

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.

Full 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.

Enrollment: 105 estimated patients

Sex: Female

Ages: 40 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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105 participants in 3 patient groups

Fentanyl group(group F)

Active Comparator group

Description:

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

Treatment:

Drug: the drug of intravenous patient-controlled analgesia

Oxycodone group(group O)

Experimental group

Description:

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

Treatment:

Drug: the drug of intravenous patient-controlled analgesia

Butorphanol group(group B)

Experimental group

Description:

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

Treatment:

Drug: the drug of intravenous patient-controlled analgesia