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Completed

NCT Number: NCT03496194

Anaesthesiological Involvement in Postoperative Pain Treatment

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre for Anaesthesiological Research (CAR)

Køge, 4600, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All departments of anesthesia with a PACU in Denmark

Exclusion criteria

  • PACUs as part of day case surgery will be excluded

Treatment and study plan

Primary outcomes

  1. Proportion of hospitals, with a department of anesthesia, providing postoperative monitoring of epidural analgesia on postoperative day (POD) one.

    Time frame: From april 15th to may 1st 2018.

    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.

Secondary outcomes

  1. Size of hospital (number of beds)

    Time frame: From april 15th to may 1st 2018.

    Number of beds

  2. Number of Post Anesthesia Care Units (PACU)

    Time frame: From april 15th to may 1st 2018.

    Number of PACU's

  3. Size of PACU (number of beds)

    Time frame: From april 15th to may 1st 2018.

    Number of beds

  4. Availability of a well defined acute pain unit with connected personnel

    Time frame: From april 15th to may 1st 2018.

    The respondent will choose "yes", "no" or "don't know"

  5. Availability of a chronical pain unit/pain clinic

    Time frame: From april 15th to may 1st 2018.

    The respondent will choose "yes", "no" or "don't know"

  6. Availability of a specialized pain unit for children

    Time frame: From april 15th to may 1st 2018.

    The respondent will choose "yes", "no" or "don't know"

  7. Involvement of the department of anesthesia in inspection of patients with postoperative pain

    Time frame: From april 15th to may 1st 2018.

    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.

  8. Availability of a general protocol for postoperative pain in the PACU?

    Time frame: From april 15th to may 1st 2018.

    The respondent will choose "yes", "no" or "don't know"

  9. Availability of a procedure specific protocol for postoperative pain

    Time frame: From april 15th to may 1st 2018.

    The respondent will choose "yes", "no" or "don't know"

  10. Elaboration on the availability of a procedure specific protocol for postoperative pain between specialties

    Time frame: From april 15th to may 1st 2018.

    The respondent will choose "yes", "no", "not relevant for my department" or "don't know" for each specialty

  11. Availability of protocols for perioperative management for patients with complicated pain issues and/or high opioid consumption

    Time frame: From april 15th to may 1st 2018.

    The respondent will choose "yes", "no" or "don't know"

  12. Follow-up for patients with complicated pain issues after discharge from the hospital

    Time frame: From april 15th to may 1st 2018.

    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.

  13. Type of invasive pain treatment offered

    Time frame: From april 15th to may 1st 2018.

    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"

  14. Daily responsibility for follow-up/control of invasive pain treatment when the patients leave the PACU

    Time frame: From april 15th to may 1st 2018.

    The respondent will choose from a list of options: "Department of anesthesia", "The ward", "Don't know" or "Other": the respondent will specify

  15. Routinely inspection by the department of anesthesia of the invasive pain treatment

    Time frame: From april 15th to may 1st 2018.

    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.

  16. Routinely inspection by the department of anesthesia of the invasive pain treatment with regards to involved personnel

    Time frame: From april 15th to may 1st 2018.

    The respondent will choose from a list of options: "Physician", "Nurse", "Acute pain team", "Chronical pain unit" or "Other": the respondent will specify.

  17. Decisions on removal and duration of treatment with an epidural catheter

    Time frame: From april 15th to may 1st 2018.

    The respondent will choose from a list of options: "Department of anesthesia", "The ward", "Don't know" or "Other": the respondent will specify.

  18. Involvement of the department of anesthesia in extension of the invasive pain treatment

    Time frame: From april 15th to may 1st 2018.

    The respondent will choose from a list of options: "Yes, every time", "Yes often", "Yes rarely", "No never" or "Don't know"

  19. Participation of the department of anesthesia in other activities regarding postoperative pain treatment

    Time frame: From april 15th to may 1st 2018.

    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.

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Official study title

Anaesthesiological Involvement in Postoperative Pain Treatment - A Questionnaire Survey at Danish Hospitals

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 12, 2018
Registry last updated
Nov 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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