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

Endometrial Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04295109
• Other study ID #: 2019-SR-476
• Status: Recruiting
• Phase: N/A
• Start date: March 2, 2020
• Est. completion date: July 31, 2020

Study information

• Verified date: April 2020
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: Cunming Liu, doctorate
• Phone: 13951890866
• Email: 1335587409[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenomyosis
• Cervix Neoplasms
• Endometrial Cancer
• Endometrial Neoplasms
• Fibroid Uterus
• Leiomyoma
• Uterine Cervical Neoplasms

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital with Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative time to first anal exhaust	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
Primary	the cumulative dose administered in the patient-controlled mode	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
Primary	effective bolus times	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	pain score	by using numerical rating scale (NRS):The pain scale ranged from 0 (=no pain) to 10 (=worst pain imaginable)	at 4 hours postoperatively
Secondary	pain score	by using numerical rating scale (NRS):The pain scale ranged from 0 (=no pain) to 10 (=worst pain imaginable)	at 12 hours postoperatively
Secondary	pain score	by using numerical rating scale (NRS):The pain scale ranged from 0 (=no pain) to 10 (=worst pain imaginable)	at 24 hours postoperatively
Secondary	pain score	by using numerical rating scale (NRS):The pain scale ranged from 0 (=no pain) to 10 (=worst pain imaginable)	at 48 hours postoperatively
Secondary	Sedation score	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
Secondary	Sedation score	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
Secondary	Sedation score	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
Secondary	Sedation score	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
Secondary	adverse effects	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
Secondary	adverse effects	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
Secondary	adverse effects	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
Secondary	adverse effects	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
Secondary	patients' degree of overall satisfaction with the postoperative analgesia	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
Secondary	postoperative hospitalization 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