Clinical trial NCT03496194: Anaesthesiological Involvement in Postoperative Pain Treatment
Official title: Anaesthesiological Involvement in Postoperative Pain Treatment - A Questionnaire Survey at Danish Hospitals
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pain, Postoperative
Anesthesia
Epidural Analgesia
Acute Pain
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2018-04-12
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Chief physicians for the postoperative care unit (PACU) at all Danish Departments of Anaesthesia

Brief 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.

Detailed 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

Eligibility criteria: Inclusion Criteria:

* All departments of anesthesia with a PACU in Denmark

Exclusion Criteria:

* PACUs as part of day case surgery will be excluded

Primary outcomes:
measure: Proportion of hospitals, with a department of anesthesia, providing postoperative monitoring of epidural analgesia on postoperative day (POD) one.
timeFrame: From april 15th to may 1st 2018.
Secondary outcomes:
measure: Size of hospital (number of beds)
timeFrame: From april 15th to may 1st 2018.
measure: Number of Post Anesthesia Care Units (PACU)
timeFrame: From april 15th to may 1st 2018.
measure: Size of PACU (number of beds)
timeFrame: From april 15th to may 1st 2018.
measure: Availability of a well defined acute pain unit with connected personnel
timeFrame: From april 15th to may 1st 2018.
measure: Availability of a chronical pain unit/pain clinic
timeFrame: From april 15th to may 1st 2018.
measure: Availability of a specialized pain unit for children
timeFrame: From april 15th to may 1st 2018.
measure: Involvement of the department of anesthesia in inspection of patients with postoperative pain
timeFrame: From april 15th to may 1st 2018.
measure: Availability of a general protocol for postoperative pain in the PACU?
timeFrame: From april 15th to may 1st 2018.
measure: Availability of a procedure specific protocol for postoperative pain
timeFrame: From april 15th to may 1st 2018.
measure: Elaboration on the availability of a procedure specific protocol for postoperative pain between specialties
timeFrame: From april 15th to may 1st 2018.
measure: Availability of protocols for perioperative management for patients with complicated pain issues and/or high opioid consumption
timeFrame: From april 15th to may 1st 2018.
measure: Follow-up for patients with complicated pain issues after discharge from the hospital
timeFrame: From april 15th to may 1st 2018.
measure: Type of invasive pain treatment offered
timeFrame: From april 15th to may 1st 2018.
measure: Daily responsibility for follow-up/control of invasive pain treatment when the patients leave the PACU
timeFrame: From april 15th to may 1st 2018.
measure: Routinely inspection by the department of anesthesia of the invasive pain treatment
timeFrame: From april 15th to may 1st 2018.
measure: Routinely inspection by the department of anesthesia of the invasive pain treatment with regards to involved personnel
timeFrame: From april 15th to may 1st 2018.
measure: Decisions on removal and duration of treatment with an epidural catheter
timeFrame: From april 15th to may 1st 2018.
measure: Involvement of the department of anesthesia in extension of the invasive pain treatment
timeFrame: From april 15th to may 1st 2018.
measure: Participation of the department of anesthesia in other activities regarding postoperative pain treatment
timeFrame: From april 15th to may 1st 2018.
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Centre for Anaesthesiological Research (CAR)
Study officials:
affiliation: Centre for Anaesthesiological research (CAR)
name: Laura S Kruuse, Med.Student
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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. No abstract available.
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. doi: 10.1097/00000542-198801000-00016. No abstract available.
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.
citation: Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366.
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.
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. doi: 10.1177/0310057X9802600206.
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. Norwegian.
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.
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.