Clinical trial NCT04295109: Comparison of the Effects of Fentanyl, Oxycodone, Butorphanol on Gastrointestinal Function
Official title: Comparison of the Effects of Fentanyl, Oxycodone, Butorphanol on Gastrointestinal Function in Patients Undergoing Laparoscopic Hysterectomy: a Double-blind, a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cervix Neoplasms
Endometrial Cancer
Adenomyosis
Fibroid Uterus
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2020-03-04
Enrollment: 105
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: postoperative time to first anal exhaust
timeFrame: 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
measure: the cumulative dose administered in the patient-controlled mode
timeFrame: From date of operation until the date of first documented progression of anal exhaust , assessed up to 48 hours
measure: effective bolus times
timeFrame: From date of operation until the date of first documented progression of anal exhaust , assessed up to 48 hours
Secondary outcomes:
measure: pain score
timeFrame: at 4 hours postoperatively
measure: pain score
timeFrame: at 12 hours postoperatively
measure: pain score
timeFrame: at 24 hours postoperatively
measure: pain score
timeFrame: at 48 hours postoperatively
measure: Sedation score
timeFrame: at 4 hours postoperatively
measure: Sedation score
timeFrame: at 12 hours postoperatively
measure: Sedation score
timeFrame: at 24 hours postoperatively
measure: Sedation score
timeFrame: at 48 hours postoperatively
measure: adverse effects
timeFrame: at 4 hours postoperatively
measure: adverse effects
timeFrame: at 12 hours postoperatively
measure: adverse effects
timeFrame: at 24 hours postoperatively
measure: adverse effects
timeFrame: at 48 hours postoperatively
measure: patients' degree of overall satisfaction with the postoperative analgesia
timeFrame: at 48 hours postoperatively
measure: postoperative hospitalization days
timeFrame: 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
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital with Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Cunming Liu, doctorate
role: PRINCIPAL_INVESTIGATOR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Shijiang Liu, Master
role: STUDY_CHAIR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Chuanbao Han
role: STUDY_DIRECTOR
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Minna Guo
role: STUDY_CHAIR
References:
citation: 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.