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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Enrollment
105
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.
The First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, China
RECRUITINGpostoperative time to first anal exhaust
Timing from the end of the operation
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
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
Time frame: From date of operation until the date of first documented progression of anal exhaust , assessed up to 48 hours
effective bolus times
The effective bolus times in the patient-controlled mode during the initial 48 hours after the operation was measured
Time frame: From date of operation until the date of first documented progression of anal exhaust , assessed up to 48 hours
pain score
by using numerical rating scale (NRS):The pain scale ranged from 0 (=no pain) to 10 (=worst pain imaginable)
Time frame: at 4 hours postoperatively
pain score
by using numerical rating scale (NRS):The pain scale ranged from 0 (=no pain) to 10 (=worst pain imaginable)
Time frame: at 12 hours postoperatively
pain score
by using numerical rating scale (NRS):The pain scale ranged from 0 (=no pain) to 10 (=worst pain imaginable)
Time frame: at 24 hours postoperatively
pain score
by using numerical rating scale (NRS):The pain scale ranged from 0 (=no pain) to 10 (=worst pain imaginable)
Time frame: at 48 hours postoperatively
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）
Time frame: at 4 hours postoperatively
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）
Time frame: at 12 hours postoperatively
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）
Time frame: at 24 hours postoperatively
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）
Time frame: at 48 hours postoperatively
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
Time frame: at 4 hours postoperatively
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
Time frame: at 12 hours postoperatively
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
Time frame: at 24 hours postoperatively
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
Time frame: at 48 hours postoperatively
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).
Time frame: at 48 hours postoperatively
postoperative hospitalization days
All patients were cured in accordance with clinical cure standard
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
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