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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03496194
Other study ID # ZUH
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 13, 2018
Est. completion date June 6, 2018

Study information

Verified date April 2018
Source Zealand University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study aims to investigate the current organization and management of postoperative pain in Denmark, especially for invasive pain treatment modalities (epidural infusions, PCA and regional blocks), in a national survey covering the activities in Danish Hospitals. This study is an electronic questionnaire survey, that aim to describe and map the foundation for future developments within, and improvement of, postoperative pain management.


Description:

Postoperative pain is one of the major challenges in postoperative care and several studies continue to demonstrate that postoperative pain is generally undertreated. A key focus for postoperative pain is to identify gold standards within procedure-specific pain treatment. However, results from single randomized trials do not per se lead to better treatment, as this requires both efforts within implementation of best evidence, quality control of efficacy, including efficacy on the individual level, and education of staff and physicians. It has been suggested, that a way forward must include changes at the organizational level. For basic postoperative pain treatment, the major responsibility for planning and execution often rests on the surgical departments. For invasive pain treatment methods, e.g. epidural analgesia with continual infusion, patient controlled epidural analgesia (PCEA), patient controlled analgesia (PCA), and regional blocks, both single and continuing, this treatment is instituted at the departments of anaesthesia, but the responsibility for follow up is rarely described. Generally, epidural analgesia is widely recommended because of superior benefits in reducing postoperative pain, pulmonal complications and surgical stress, as compared to systemic opioid treatment. However, epidural analgesia is not without complications especially not for abdominal and thoracic surgery. The accompanying unwanted motor blockade may delay recovery and recent studies question this treatment. Likewise, up to 20 % percent of patients will not receive adequate analgesia for the first 48 hours postoperative with this method. Finally, it is possible, that adverse effects and complications from epidural treatment are currently being underestimated, due to lack of routine monitoring and missing protocols. Besides epidural analgesia, the use of Patient controlled analgesia (PCA), Patient controlled epidural analgesia (PCEA) and regional blocks have gained ground the last decades. With these techniques it might be possible to reduce overall opioid requirements. Nevertheless, a daily evaluation of benefits and harms of such analgesic techniques may be required to justify these treatment modalities. It is suggested, that regularly monitoring of invasive analgesic methods is of great concern when it comes to optimal postoperative pain management and reduction of adverse effects. A structured organizational approach has the potential to improve benefit and harm of postoperative pain management. A number of studies argues that in order to obtain optimal postoperative pain treatment there need to be regular monitoring, and optimization of the analgesic regimens and techniques, preferably in a clinical setting with either an Acute Pain Service (APS) or a similar setup. With the decline of the use of APS's in Denmark it seems that the organization and management around postoperative pain treatment in general, and for invasive pain treatment methods in particular, needs to be investigated. As of today, it is not known how patients with such pain treatment are monitored and taken care of after leaving the post anaesthesia care unit, and where the responsibility for this pain treatment lies


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date June 6, 2018
Est. primary completion date May 5, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - All departments of anesthesia with a PACU in Denmark Exclusion Criteria: - PACUs as part of day case surgery will be excluded

Study Design


Locations

Country Name City State
Denmark Centre for Anaesthesiological Research (CAR) Køge

Sponsors (1)

Lead Sponsor Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (11)

Apfelbaum JL, Chen C, Mehta SS, Gan TJ. Postoperative pain experience: results from a national survey suggest postoperative pain continues to be undermanaged. Anesth Analg. 2003 Aug;97(2):534-540. doi: 10.1213/01.ANE.0000068822.10113.9E. — View Citation

Breivik H, Norum HM. [Regional analgesia--risks and benefits]. Tidsskr Nor Laegeforen. 2010 Feb 25;130(4):392-7. doi: 10.4045/tidsskr.08.0220. Review. Norwegian. — View Citation

Burstal R, Wegener F, Hayes C, Lantry G. Epidural analgesia: prospective audit of 1062 patients. Anaesth Intensive Care. 1998 Apr;26(2):165-72. — View Citation

Duncan F. Prospective observational study of postoperative epidural analgesia for major abdominal surgery. J Clin Nurs. 2011 Jul;20(13-14):1870-9. doi: 10.1111/j.1365-2702.2011.03752.x. Epub 2011 May 25. — View Citation

Golster M. Seven years of patient-controlled epidural analgesia in a Swedish hospital: a prospective survey. Eur J Anaesthesiol. 2014 Nov;31(11):589-96. doi: 10.1097/EJA.0000000000000105. — View Citation

Mathiesen O, Thomsen BA, Kitter B, Dahl JB, Kehlet H. Need for improved treatment of postoperative pain. Dan Med J. 2012 Apr;59(4):A4401. — View Citation

Nielsen PR, Christensen PA, Meyhoff CS, Werner MU. Post-operative pain treatment in Denmark from 2000 to 2009: a nationwide sequential survey on organizational aspects. Acta Anaesthesiol Scand. 2012 Jul;56(6):686-94. doi: 10.1111/j.1399-6576.2012.02662.x. Epub 2012 Mar 5. — View Citation

Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366. Review. — View Citation

Rawal N. Epidural technique for postoperative pain: gold standard no more? Reg Anesth Pain Med. 2012 May-Jun;37(3):310-7. doi: 10.1097/AAP.0b013e31825735c6. Review. — View Citation

Ready LB, Oden R, Chadwick HS, Benedetti C, Rooke GA, Caplan R, Wild LM. Development of an anesthesiology-based postoperative pain management service. Anesthesiology. 1988 Jan;68(1):100-6. — View Citation

White PF, Kehlet H. Improving postoperative pain management: what are the unresolved issues? Anesthesiology. 2010 Jan;112(1):220-5. doi: 10.1097/ALN.0b013e3181c6316e. Review. — View Citation

* Note: There are 11 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of hospitals, with a department of anesthesia, providing postoperative monitoring of epidural analgesia on postoperative day (POD) one. The respondent will answer the question: "What invasive pain treatments are routinely inspected by the department of anesthesia" and choose from a list of options: "No", "Yes 1. POD", "Yes 2. POD", "Yes 3. POD" or "other": the respondent will specify. From april 15th to may 1st 2018.
Secondary Size of hospital (number of beds) Number of beds From april 15th to may 1st 2018.
Secondary Number of Post Anesthesia Care Units (PACU) Number of PACU's From april 15th to may 1st 2018.
Secondary Size of PACU (number of beds) Number of beds From april 15th to may 1st 2018.
Secondary Availability of a well defined acute pain unit with connected personnel The respondent will choose "yes", "no" or "don't know" From april 15th to may 1st 2018.
Secondary Availability of a chronical pain unit/pain clinic The respondent will choose "yes", "no" or "don't know" From april 15th to may 1st 2018.
Secondary Availability of a specialized pain unit for children The respondent will choose "yes", "no" or "don't know" From april 15th to may 1st 2018.
Secondary Involvement of the department of anesthesia in inspection of patients with postoperative pain The respondent will choose from a list of options: "On request from the ward", "Agreements on certain types of patients", "As a part of the work of the Acute Pain Service", "As part of the work of the chronical pain team", "We don't make inspections" or "Other": the respondent will specify. From april 15th to may 1st 2018.
Secondary Availability of a general protocol for postoperative pain in the PACU? The respondent will choose "yes", "no" or "don't know" From april 15th to may 1st 2018.
Secondary Availability of a procedure specific protocol for postoperative pain The respondent will choose "yes", "no" or "don't know" From april 15th to may 1st 2018.
Secondary Elaboration on the availability of a procedure specific protocol for postoperative pain between specialties The respondent will choose "yes", "no", "not relevant for my department" or "don't know" for each specialty From april 15th to may 1st 2018.
Secondary Availability of protocols for perioperative management for patients with complicated pain issues and/or high opioid consumption The respondent will choose "yes", "no" or "don't know" From april 15th to may 1st 2018.
Secondary Follow-up for patients with complicated pain issues after discharge from the hospital The respondent will choose from a list of options: "Yes at the surgical department", "Yes at the multidisciplinary pain team/ chronical pain unit", "Yes at the local physician", "No follow-up", "Don't know" or "Other": the respondent will specify. From april 15th to may 1st 2018.
Secondary Type of invasive pain treatment offered The respondent will choose from a list of options: "Epidural Pain Catheter", "PCEA", "PCA", "Regional Block (single shot)", "Regional Block (continual infusion)", "Regional Block (patient controlled bolus)", "Other": the respondent will specify og "No, none of the above" From april 15th to may 1st 2018.
Secondary Daily responsibility for follow-up/control of invasive pain treatment when the patients leave the PACU The respondent will choose from a list of options: "Department of anesthesia", "The ward", "Don't know" or "Other": the respondent will specify From april 15th to may 1st 2018.
Secondary Routinely inspection by the department of anesthesia of the invasive pain treatment The respondent will choose from a list of options:"No", "Yes 1. POD", "Yes 2. POD", "Yes 3. POD" or "other": the respondent will specify for each invasive pain treatment offered at the hospital. From april 15th to may 1st 2018.
Secondary Routinely inspection by the department of anesthesia of the invasive pain treatment with regards to involved personnel The respondent will choose from a list of options: "Physician", "Nurse", "Acute pain team", "Chronical pain unit" or "Other": the respondent will specify. From april 15th to may 1st 2018.
Secondary Decisions on removal and duration of treatment with an epidural catheter The respondent will choose from a list of options: "Department of anesthesia", "The ward", "Don't know" or "Other": the respondent will specify. From april 15th to may 1st 2018.
Secondary Involvement of the department of anesthesia in extension of the invasive pain treatment The respondent will choose from a list of options: "Yes, every time", "Yes often", "Yes rarely", "No never" or "Don't know" From april 15th to may 1st 2018.
Secondary Participation of the department of anesthesia in other activities regarding postoperative pain treatment The respondent will choose from a list of options: "Education in pain treatment", "Departmental quality assesment including guidelines and audits), "Implementation", "Research" or "Other": the respondent will specify. From april 15th to may 1st 2018.
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