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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fentanyl group(group F) | Active Comparator | 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 |
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| Oxycodone group(group O) | Experimental | 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 |
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| Butorphanol group(group B) | Experimental | 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| the drug of intravenous patient-controlled analgesia | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| pain score | by using numerical rating scale (NRS):The pain scale ranged from 0 (=no pain) to 10 (=worst pain imaginable) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cunming Liu, doctorate | Contact | 13951890866 | 1335587409@qq.com | |
| Minna Guo, Master | Contact | 18835162576 | 1653474602@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Cunming Liu, doctorate | The First Affiliated Hospital with Nanjing Medical University | Principal Investigator |
| Shijiang Liu, Master | The First Affiliated Hospital with Nanjing Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital with Nanjing Medical University | Recruiting | Nanjing | Jiangsu | 210029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35209847 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 5, 2020 | |
| Reset | Jul 21, 2020 | |
| Release | May 18, 2022 |
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| 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) | 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) | 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） | 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） | 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） | 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） | 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 | 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 | 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 | 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 | 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). | at 48 hours postoperatively |
| 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 |
| Chuanbao Han | The First Affiliated Hospital with Nanjing Medical University | Study Director |
| Minna Guo | The First Affiliated Hospital with Nanjing Medical University | Study Chair |
| Reset | Feb 16, 2023 |
| Release | Mar 11, 2023 |
| Reset | Dec 7, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 5, 2020 | Jul 21, 2020 | |||
| May 18, 2022 | Feb 16, 2023 | |||
| Mar 11, 2023 | Dec 7, 2023 |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D016889 | Endometrial Neoplasms |
| D062788 | Adenomyosis |
| D007889 | Leiomyoma |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D009379 | Neoplasms, Muscle Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D016058 | Analgesia, Patient-Controlled |
| ID | Term |
|---|---|
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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