IleusNCT05262569
Postoperative Opioid Use and Ileus Occurrence---A Case Control Study
An observational study of Ileus and Opioid Use, run by Peking University People's Hospital at 1 site in China.
Trial summary
Postoperative ileus (POI) is a significant complication after colorectal surgery, with reported incidence ranging from 10~30%, leading to increased morbidity, hospital length of stay, and thus medical cost. To determine the risk factors for POI is one of the key elements for Enhanced Recovery after Surgery protocol. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ileus, Opioid Use
- What is being tested?
- ileus
- How many people
- 596 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All elective laparoscopic colorectal procedures performed at a university hospital between Jan 2018 and June 2020 were retrospectively collected by reviewing the institutional colorectal surgery database.
Who may be able to join
- Aged 18 years old and above
- Underwent elective laparoscopic colorectal procedures
- Received patient controlled intravenous analgesia postoperatively
Who cannot join
- Chronic opioid use
- Converted to open
- Admitted to ICU
- PCA regimens other than sufentanil
- PCA used shorter than 48 hours
- Incomplete postoperative opioid usage record
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
Official title: Increased Postoperative Opioid Use is a Risk Factor for an Ileus After Laparoscopic Colorectal Surgery---A Case Control Study
Postoperative ileus (POI) is a significant complication after colorectal surgery, with reported incidence ranging from 10~30%, leading to increased morbidity, hospital length of stay, and thus medical cost. To determine the risk factors for POI is one of the key elements for Enhanced Recovery after Surgery protocol. Increased perioperative opioid usage has been proposed as an independent risk factor for postoperative ileus, as perioperative opioid minimization has proposed to be an effective measure to decrease the incidence of POI. Although opioids are widely used to attenuate stress during surgery, and represent the cornerstone of pain treatment, anesthesiologists are strive to minimize opioid use to decrease opioid-related GI side effects. In this study, the investigators aim to find out the general occurrence of POI in the laparoscopic colorectal surgery and the effects of the postoperative opioid usage on this outcome. The strategies of opioid minimization was also investigated.
Read the detailed description
2.1 Study design For this case-control study, all elective laparoscopic colorectal procedures performed at a university hospital between Jan 2018 and June 2020 were retrospectively collected by reviewing the institutional colorectal surgery database. The study protocol was approved by the Institutional Review Board of Peking University People's Hospital (2021PHB144-001, May 24, 2021), Beijing, China, and informed consent was waived due to the retrospective design.
The anesthesia medical information system was searched for patients aged 18 years old and above, undergoing elective laparoscopic colorectal procedures who received patient controlled intravenous analgesia postoperatively. Patients were excluded if they had chronic opioid use, converted to open, admitted to intensive care unit(ICU), patient controlled analgesia (PCA) regimens other than sufentanil, PCA used shorter than 48 hours, or incomplete postoperative opioid usage record. Patients were followed up until discharge from the hospital.
2.2 Patient allocation Patients who experienced postoperative ileus were included in ileus group. In accordance with the definition of Vather et al, diagnosis of postoperative ileus required 2 or more of following persistent symptoms on the fourth postoperative day and onward: nausea and vomiting, inability to tolerate solid or semi-liquid diet or failure to pass gas or stool during a 24 hour period, abdominal distension and radiological evidence of ileus. Patient charts, including radiographs were evaluated retrospectively. Diagnosis of an ileus was confirmed clinically and radiographically in all cases. The control group (at a 1:1 ratio) was matched by selecting the same range of age (±5 years of age), the same grade of American Society of Anesthesiology(ASA) classification, and the same types of surgery (colectomy, rectectomy, whole colon resection, or others).
2.3 Perioperative management All patients received standard anesthesia protocol for laparoscopic colorectal procedures within Peking University People's Hospital. Patients might received bilateral transversus abdominis plane(TAP) blocks (0.3% Ropivacaine of 30~40ml under the ultrasound guidance) at the discretion of the anesthesiologist in charge.
General anesthesia was induced using etomidate (0.2-0.6 mg/kg) and sufentanil (0.3 μg/kg) and maintained with continuous infusion of propofol (4-6 mg/kg/h) to target a bispectral index of 40-60. Cisatracurium (0.15 mg/kg) was injected intravenously to facilitate endotracheal intubation. Intravenous sufentanil (0.1 μg/kg) was added before skin incision. During surgery, continuous infusion of remifentanil (0.1-0.2 μg /kg/min) was adjusted to keep heart rate (HR) and mean arterial blood pressure (MAP) within 80-120% of baseline. Hypotension (MAP < 80% of baseline) lasting for 3 min was managed with a bolus of 6 mg of ephedrine or 50 μg of phenylephrine. Bradycardia (HR < 45/min) was treated with atropine (0.25-0.5 mg). At the end of surgery, neostigmine (1 mg) and atropine (0.5 mg) were used to antagonize neuromuscular blockade, and tracheal extubation was performed when the patient was fully awake and breathing adequately. Patients were transferred to the post-anesthesia care unit (PACU) and discharged when the Modified Aldrete Score reached 10.
2.4 Postoperative pain management Postoperative pain management was charged by the acute pain service(APS). Acute pain or side effects related to the opioid was managed through the setting of intravenous patient-controlled analgesia(PCA) device. Patients received intravenous, intramuscular or oral analgesic rescue only after the PCA withdrawal.
In general, a patient-controlled analgesia (PCA) device was attached after tracheal extubation. The PCA was set to provide a bolus of 2~3μg sufentanil (1 μg/ml) with a lockout time of 10~15 min with or without basal infusion, 2~3ml/h (sufentanil 1μg/ml), which was set at the discretion of the anesthesiologist in charge according to the patient's age and weight. After surgery, pain score was verbally rated using the 11-point numeric rating scale (NRS), on which 0 indicates no pain and 10 indicates worst imaginable pain. Patients could self-administer intravenous sufentanil bolus via PCA (2~3μg, 1 μg/ml) postoperatively as rescue analgesia when the NRS score was ≥4, or as needed. PCA was maintained for at least the first 48 h after surgery.
2.5 Study outcomes and measurements Multiple potential risk factors for POI were considered based on literature review. Baseline factors included age(matched), gender, BMI, presence of major comorbidities (cardiovascular diseases, cerebral diseases, pulmonary diseases, or diabetes), ASA classification (matched), and previous abdominal surgery. Operative factors included type of surgery(matched), length of the surgery, estimated blood loss, total input, time to pass stool in patients' without enterostomy, time to tolerance of oral diet, and postoperative length of hospital stay. Analgesia related risk factors included TAP block, intra-operative opioid use(converted into equivalent doses of morphine, mg/kg), postoperative day 1 (POD1) and total post-operative opioid (Sufentanil, μg/kg), and PCA setting (with or without basal infusion). Postoperative NRS at rest and when coughing were recorded. Adverse events occurring prior to discharge were also collected from the hospital chart.
2.6 Statistical analysis Statistical analysis was performed using the SPSS statistical software package (SPSS Inc., Chicago, IL). Continuous variables are expressed as mean ± standard deviation(SD) or medians with interquartile range and categorical variables as numbers and percentages. Between-group differences were evaluated using the independent t test or Mann-Whitney U test for continuous variables and the χ2 test or Fisher exact test for categorical variables, as appropriate.
- Conditions
- Ileus, Opioid Use
- Being tested
- ileus
- Keywords
- ileus, opioid use, enhanced recovery after surgery, colorectal surgery
- Medical subject headings
- Ileus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ileusOther
retrospectively allocation according to a postoperative outcome-ileus
| Study group | Role | What they receive |
|---|---|---|
| ileus group | Patients developed postoperative ileus Receives: Other: ileus | |
| control group | Patients did not develop postoperative ileus |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative opioid usage
Sufentanil(μg/kg) used through patient-controlled analgesia
Measured: Within 3 postoperative days
Secondary outcomes (2)
Use of transversus abdominis plane(TAP) block
The percentage TAP block of each group
Measured: Before surgery
Patent-controlled analgesia(PCA) setting
The percentage of PCA setting with basal infusion
Measured: Within 3 postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Apr 2022
- Primary completion31 May 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for IleusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 596 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juhui, Peking University People's Hospital
- Investigators
- Juhui, Dr., Principal investigator, Peking University People's Hospital, Beijing, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262569
- Sponsor's protocol ID
- Opioid and postoperative POI
- Status last verified
- Aug 2022
- First submitted
- 22 Feb 2022
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It need to be discussed within the study group when the results are clear.
Publications
Wu CL, King AB, Geiger TM, Grant MC, Grocott MPW, Gupta R, Hah JM, Miller TE, Shaw AD, Gan TJ, Thacker JKM, Mythen MG, McEvoy MD; Fourth Perioperative Quality Initiative Workgroup. American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Perioperative Opioid Minimization in Opioid-Naive Patients. Anesth Analg. 2019 Aug;129(2):567-577. doi: 10.1213/ANE.0000000000004194.
PubMed 31082966Artinyan A, Nunoo-Mensah JW, Balasubramaniam S, Gauderman J, Essani R, Gonzalez-Ruiz C, Kaiser AM, Beart RW Jr. Prolonged postoperative ileus-definition, risk factors, and predictors after surgery. World J Surg. 2008 Jul;32(7):1495-500. doi: 10.1007/s00268-008-9491-2.
PubMed 18305994Pappagallo M. Incidence, prevalence, and management of opioid bowel dysfunction. Am J Surg. 2001 Nov;182(5A Suppl):11S-18S. doi: 10.1016/s0002-9610(01)00782-6.
PubMed 11755892Camilleri M. Opioid-induced constipation: challenges and therapeutic opportunities. Am J Gastroenterol. 2011 May;106(5):835-42; quiz 843. doi: 10.1038/ajg.2011.30. Epub 2011 Feb 22.
PubMed 21343919Ahn JH, Ahn HJ. Effect of thoracic epidural analgesia on recovery of bowel function after major upper abdominal surgery. J Clin Anesth. 2016 Nov;34:247-52. doi: 10.1016/j.jclinane.2016.04.042. Epub 2016 May 13.
PubMed 27687384Stokes AL, Adhikary SD, Quintili A, Puleo FJ, Choi CS, Hollenbeak CS, Messaris E. Liposomal Bupivacaine Use in Transversus Abdominis Plane Blocks Reduces Pain and Postoperative Intravenous Opioid Requirement After Colorectal Surgery. Dis Colon Rectum. 2017 Feb;60(2):170-177. doi: 10.1097/DCR.0000000000000747.
PubMed 28059913Fields AC, Weiner SG, Maldonado LJ, Cavallaro PM, Melnitchouk N, Goldberg J, Stopfkuchen-Evans MF, Baker O, Bordeianou LG, Bleday R. Implementation of liposomal bupivacaine transversus abdominis plane blocks into the colorectal enhanced recovery after surgery protocol: a natural experiment. Int J Colorectal Dis. 2020 Jan;35(1):133-138. doi: 10.1007/s00384-019-03457-1. Epub 2019 Dec 4.
PubMed 31797098Pedrazzani C, Menestrina N, Moro M, Brazzo G, Mantovani G, Polati E, Guglielmi A. Local wound infiltration plus transversus abdominis plane (TAP) block versus local wound infiltration in laparoscopic colorectal surgery and ERAS program. Surg Endosc. 2016 Nov;30(11):5117-5125. doi: 10.1007/s00464-016-4862-5. Epub 2016 Mar 22.
PubMed 27005290Chen JY, Ko TL, Wen YR, Wu SC, Chou YH, Yien HW, Kuo CD. Opioid-sparing effects of ketorolac and its correlation with the recovery of postoperative bowel function in colorectal surgery patients: a prospective randomized double-blinded study. Clin J Pain. 2009 Jul-Aug;25(6):485-9. doi: 10.1097/AJP.0b013e31819a506b.
PubMed 19542795Aryaie AH, Lalezari S, Sergent WK, Puckett Y, Juergens C, Ratermann C, Ogg C. Decreased opioid consumption and enhance recovery with the addition of IV Acetaminophen in colorectal patients: a prospective, multi-institutional, randomized, double-blinded, placebo-controlled study (DOCIVA study). Surg Endosc. 2018 Aug;32(8):3432-3438. doi: 10.1007/s00464-018-6062-y. Epub 2018 Jan 19.
PubMed 29352454Jung H, Lee KH, Jeong Y, Lee KH, Yoon S, Kim WH, Lee HJ. Effect of Fentanyl-Based Intravenous Patient-Controlled Analgesia with and without Basal Infusion on Postoperative Opioid Consumption and Opioid-Related Side Effects: A Retrospective Cohort Study. J Pain Res. 2020 Nov 24;13:3095-3106. doi: 10.2147/JPR.S281041. eCollection 2020.
PubMed 33262644Vather R, Josephson R, Jaung R, Robertson J, Bissett I. Development of a risk stratification system for the occurrence of prolonged postoperative ileus after colorectal surgery: a prospective risk factor analysis. Surgery. 2015 Apr;157(4):764-73. doi: 10.1016/j.surg.2014.12.005. Epub 2015 Feb 25.
PubMed 25724094Vather R, Bissett IP. Risk factors for the development of prolonged post-operative ileus following elective colorectal surgery. Int J Colorectal Dis. 2013 Oct;28(10):1385-91. doi: 10.1007/s00384-013-1704-y. Epub 2013 May 21.
PubMed 23689489Grass F, Slieker J, Jurt J, Kummer A, Sola J, Hahnloser D, Demartines N, Hubner M. Postoperative ileus in an enhanced recovery pathway-a retrospective cohort study. Int J Colorectal Dis. 2017 May;32(5):675-681. doi: 10.1007/s00384-017-2789-5. Epub 2017 Mar 11.
PubMed 28285365Yuan L, O'Grady G, Milne T, Jaung R, Vather R, Bissett IP. Prospective comparison of return of bowel function after left versus right colectomy. ANZ J Surg. 2018 Apr;88(4):E242-E247. doi: 10.1111/ans.13823. Epub 2016 Nov 2.
PubMed 27806440
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increased Postoperative Opioid Use is a Risk Factor for an Ileus After Laparoscopic Colorectal Surgery---A Case Control Study
- ClinicalTrials.gov ID
- NCT05262569
- Acronym / sponsor ID
- Opioid and postoperative POI
- Conditions
- Ileus, Opioid Use
- Keywords
- ileus, opioid use, enhanced recovery after surgery, colorectal surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 596 participants (actual)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative ileus (POI) is a significant complication after colorectal surgery, with reported incidence ranging from 10~30%, leading to increased morbidity, hospital length of stay, and thus medical cost. To determine the risk factors for POI is one of the key elements for Enhanced Recovery after Surgery protocol. Increased perioperative opioid usage has been proposed as an independent risk factor for postoperative ileus, as perioperative opioid minimization has proposed to be an effective measure to decrease the incidence of POI. Although opioids are widely used to attenuate stress during surgery, and represent the cornerstone of pain treatment, anesthesiologists are strive to minimize opioid use to decrease opioid-related GI side effects. In this study, the investigators aim to find out the general occurrence of POI in the laparoscopic colorectal surgery and the effects of the postoperative opioid usage on this outcome. The strategies of opioid minimization was also investigated.
Detailed description
2.1 Study design For this case-control study, all elective laparoscopic colorectal procedures performed at a university hospital between Jan 2018 and June 2020 were retrospectively collected by reviewing the institutional colorectal surgery database. The study protocol was approved by the Institutional Review Board of Peking University People's Hospital (2021PHB144-001, May 24, 2021), Beijing, China, and informed consent was waived due to the retrospective design.
The anesthesia medical information system was searched for patients aged 18 years old and above, undergoing elective laparoscopic colorectal procedures who received patient controlled intravenous analgesia postoperatively. Patients were excluded if they had chronic opioid use, converted to open, admitted to intensive care unit(ICU), patient controlled analgesia (PCA) regimens other than sufentanil, PCA used shorter than 48 hours, or incomplete postoperative opioid usage record. Patients were followed up until discharge from the hospital.
2.2 Patient allocation Patients who experienced postoperative ileus were included in ileus group. In accordance with the definition of Vather et al, diagnosis of postoperative ileus required 2 or more of following persistent symptoms on the fourth postoperative day and onward: nausea and vomiting, inability to tolerate solid or semi-liquid diet or failure to pass gas or stool during a 24 hour period, abdominal distension and radiological evidence of ileus. Patient charts, including radiographs were evaluated retrospectively. Diagnosis of an ileus was confirmed clinically and radiographically in all cases. The control group (at a 1:1 ratio) was matched by selecting the same range of age (±5 years of age), the same grade of American Society of Anesthesiology(ASA) classification, and the same types of surgery (colectomy, rectectomy, whole colon resection, or others).
2.3 Perioperative management All patients received standard anesthesia protocol for laparoscopic colorectal procedures within Peking University People's Hospital. Patients might received bilateral transversus abdominis plane(TAP) blocks (0.3% Ropivacaine of 30~40ml under the ultrasound guidance) at the discretion of the anesthesiologist in charge.
General anesthesia was induced using etomidate (0.2-0.6 mg/kg) and sufentanil (0.3 μg/kg) and maintained with continuous infusion of propofol (4-6 mg/kg/h) to target a bispectral index of 40-60. Cisatracurium (0.15 mg/kg) was injected intravenously to facilitate endotracheal intubation. Intravenous sufentanil (0.1 μg/kg) was added before skin incision. During surgery, continuous infusion of remifentanil (0.1-0.2 μg /kg/min) was adjusted to keep heart rate (HR) and mean arterial blood pressure (MAP) within 80-120% of baseline. Hypotension (MAP < 80% of baseline) lasting for 3 min was managed with a bolus of 6 mg of ephedrine or 50 μg of phenylephrine. Bradycardia (HR < 45/min) was treated with atropine (0.25-0.5 mg). At the end of surgery, neostigmine (1 mg) and atropine (0.5 mg) were used to antagonize neuromuscular blockade, and tracheal extubation was performed when the patient was fully awake and breathing adequately. Patients were transferred to the post-anesthesia care unit (PACU) and discharged when the Modified Aldrete Score reached 10.
2.4 Postoperative pain management Postoperative pain management was charged by the acute pain service(APS). Acute pain or side effects related to the opioid was managed through the setting of intravenous patient-controlled analgesia(PCA) device. Patients received intravenous, intramuscular or oral analgesic rescue only after the PCA withdrawal.
In general, a patient-controlled analgesia (PCA) device was attached after tracheal extubation. The PCA was set to provide a bolus of 2~3μg sufentanil (1 μg/ml) with a lockout time of 10~15 min with or without basal infusion, 2~3ml/h (sufentanil 1μg/ml), which was set at the discretion of the anesthesiologist in charge according to the patient's age and weight. After surgery, pain score was verbally rated using the 11-point numeric rating scale (NRS), on which 0 indicates no pain and 10 indicates worst imaginable pain. Patients could self-administer intravenous sufentanil bolus via PCA (2~3μg, 1 μg/ml) postoperatively as rescue analgesia when the NRS score was ≥4, or as needed. PCA was maintained for at least the first 48 h after surgery.
2.5 Study outcomes and measurements Multiple potential risk factors for POI were considered based on literature review. Baseline factors included age(matched), gender, BMI, presence of major comorbidities (cardiovascular diseases, cerebral diseases, pulmonary diseases, or diabetes), ASA classification (matched), and previous abdominal surgery. Operative factors included type of surgery(matched), length of the surgery, estimated blood loss, total input, time to pass stool in patients' without enterostomy, time to tolerance of oral diet, and postoperative length of hospital stay. Analgesia related risk factors included TAP block, intra-operative opioid use(converted into equivalent doses of morphine, mg/kg), postoperative day 1 (POD1) and total post-operative opioid (Sufentanil, μg/kg), and PCA setting (with or without basal infusion). Postoperative NRS at rest and when coughing were recorded. Adverse events occurring prior to discharge were also collected from the hospital chart.
2.6 Statistical analysis Statistical analysis was performed using the SPSS statistical software package (SPSS Inc., Chicago, IL). Continuous variables are expressed as mean ± standard deviation(SD) or medians with interquartile range and categorical variables as numbers and percentages. Between-group differences were evaluated using the independent t test or Mann-Whitney U test for continuous variables and the χ2 test or Fisher exact test for categorical variables, as appropriate.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ileus group | – | Other: ileusPatients developed postoperative ileus |
| control group | – | –Patients did not develop postoperative ileus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All elective laparoscopic colorectal procedures performed at a university hospital between Jan 2018 and June 2020 were retrospectively collected by reviewing the institutional colorectal surgery database.
Key inclusion criteria (3 listed)
- Aged 18 years old and above
- Underwent elective laparoscopic colorectal procedures
- Received patient controlled intravenous analgesia postoperatively
Key exclusion criteria (6 listed)
- Chronic opioid use
- Converted to open
- Admitted to ICU
- PCA regimens other than sufentanil
- PCA used shorter than 48 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ileusretrospectively allocation according to a postoperative outcome-ileus | Other | ileus group |
Primary outcome
postoperative opioid usage
Time frame: Within 3 postoperative days
Sufentanil(μg/kg) used through patient-controlled analgesia
2 secondary outcomes
Use of transversus abdominis plane(TAP) block
Time frame: Before surgery
Patent-controlled analgesia(PCA) setting
Time frame: Within 3 postoperative days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Background: PubMed 31082966Wu CL, King AB, Geiger TM, Grant MC, Grocott MPW, Gupta R, Hah JM, Miller TE, Shaw AD, Gan TJ, Thacker JKM, Mythen MG, McEvoy MD; Fourth Perioperative Quality Initiative Workgroup. American Society for Enhanced Recovery and Perioperative Quality Initiative Joint Consensus Statement on Perioperative Opioid Minimization in Opioid-Naive Patients. Anesth Analg. 2019 Aug;129(2):567-577. doi: 10.1213/ANE.0000000000004194.
- Background: PubMed 18305994Artinyan A, Nunoo-Mensah JW, Balasubramaniam S, Gauderman J, Essani R, Gonzalez-Ruiz C, Kaiser AM, Beart RW Jr. Prolonged postoperative ileus-definition, risk factors, and predictors after surgery. World J Surg. 2008 Jul;32(7):1495-500. doi: 10.1007/s00268-008-9491-2.
- Background: PubMed 11755892Pappagallo M. Incidence, prevalence, and management of opioid bowel dysfunction. Am J Surg. 2001 Nov;182(5A Suppl):11S-18S. doi: 10.1016/s0002-9610(01)00782-6.
- Background: PubMed 21343919Camilleri M. Opioid-induced constipation: challenges and therapeutic opportunities. Am J Gastroenterol. 2011 May;106(5):835-42; quiz 843. doi: 10.1038/ajg.2011.30. Epub 2011 Feb 22.
- Background: PubMed 27687384Ahn JH, Ahn HJ. Effect of thoracic epidural analgesia on recovery of bowel function after major upper abdominal surgery. J Clin Anesth. 2016 Nov;34:247-52. doi: 10.1016/j.jclinane.2016.04.042. Epub 2016 May 13.
- Background: PubMed 28059913Stokes AL, Adhikary SD, Quintili A, Puleo FJ, Choi CS, Hollenbeak CS, Messaris E. Liposomal Bupivacaine Use in Transversus Abdominis Plane Blocks Reduces Pain and Postoperative Intravenous Opioid Requirement After Colorectal Surgery. Dis Colon Rectum. 2017 Feb;60(2):170-177. doi: 10.1097/DCR.0000000000000747.
- Background: PubMed 31797098Fields AC, Weiner SG, Maldonado LJ, Cavallaro PM, Melnitchouk N, Goldberg J, Stopfkuchen-Evans MF, Baker O, Bordeianou LG, Bleday R. Implementation of liposomal bupivacaine transversus abdominis plane blocks into the colorectal enhanced recovery after surgery protocol: a natural experiment. Int J Colorectal Dis. 2020 Jan;35(1):133-138. doi: 10.1007/s00384-019-03457-1. Epub 2019 Dec 4.
- Background: PubMed 27005290Pedrazzani C, Menestrina N, Moro M, Brazzo G, Mantovani G, Polati E, Guglielmi A. Local wound infiltration plus transversus abdominis plane (TAP) block versus local wound infiltration in laparoscopic colorectal surgery and ERAS program. Surg Endosc. 2016 Nov;30(11):5117-5125. doi: 10.1007/s00464-016-4862-5. Epub 2016 Mar 22.
- Background: PubMed 19542795Chen JY, Ko TL, Wen YR, Wu SC, Chou YH, Yien HW, Kuo CD. Opioid-sparing effects of ketorolac and its correlation with the recovery of postoperative bowel function in colorectal surgery patients: a prospective randomized double-blinded study. Clin J Pain. 2009 Jul-Aug;25(6):485-9. doi: 10.1097/AJP.0b013e31819a506b.
- Background: PubMed 29352454Aryaie AH, Lalezari S, Sergent WK, Puckett Y, Juergens C, Ratermann C, Ogg C. Decreased opioid consumption and enhance recovery with the addition of IV Acetaminophen in colorectal patients: a prospective, multi-institutional, randomized, double-blinded, placebo-controlled study (DOCIVA study). Surg Endosc. 2018 Aug;32(8):3432-3438. doi: 10.1007/s00464-018-6062-y. Epub 2018 Jan 19.
- Background: PubMed 33262644Jung H, Lee KH, Jeong Y, Lee KH, Yoon S, Kim WH, Lee HJ. Effect of Fentanyl-Based Intravenous Patient-Controlled Analgesia with and without Basal Infusion on Postoperative Opioid Consumption and Opioid-Related Side Effects: A Retrospective Cohort Study. J Pain Res. 2020 Nov 24;13:3095-3106. doi: 10.2147/JPR.S281041. eCollection 2020.
- Background: PubMed 25724094Vather R, Josephson R, Jaung R, Robertson J, Bissett I. Development of a risk stratification system for the occurrence of prolonged postoperative ileus after colorectal surgery: a prospective risk factor analysis. Surgery. 2015 Apr;157(4):764-73. doi: 10.1016/j.surg.2014.12.005. Epub 2015 Feb 25.
- Individual participant dataSharing planned: Undecided. It need to be discussed within the study group when the results are clear.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juhui, Dr. principal investigator
Peking University People's Hospital, Beijing, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ileus and Opioid Use, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative opioid usage (time frame: Within 3 postoperative days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05262569, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2022.