Post-operative pain after laparoscopic colon and rectal surgery in fast-track design. A fast-track program is an evidence-based, multimodal approach for patients undergoing surgery to reduce perioperative morbidity, hospital stay and cost and to increase patient centered well-being. Optimized pain relief is a core component of any fast-track regimen. In this context epidural analgesia has become the standard of care for early postoperative pain therapy. However, it is debated whether non-opioid analgesics should be given as adjuncts when epidural analgesia is already present. The purpose of this study is to demonstrate that the administration of etoricoxib 120mg additionally to the clinical routine therapy (epidural catheter) reduces the post-operative pain level during movement after laparoscopic colon surgery in the fast-track design.
A fast-track program is an evidence-based, multimodal approach for patients undergoing surgery to reduce perioperative morbidity, hospital stay and cost and to increase patient centered well-being. Particularly in visceral surgery of the colon it is gaining widespread acceptance (Schwenk 2009). Optimized pain relief is a core component of any fast-track regimen (Kehlet and Wilmore 2008). In this context epidural analgesia has become the standard of care for early postoperative pain therapy (Hasenberg 2009), providing superior pain relief compared to parenteral opioids (Block 2001). However, it is debated whether non-opioid analgesics should be given as adjuncts when epidural analgesia is already present. Some studies have found reduced pain using NSAID as adjunct (Scott 1994), leading to a positive recommendation in the German guidelines for postoperative pain therapy (S3-Leitlinie). However, other studies (Mogensen 1992) have not found an effect of non-opioids in addition to epidural analgesia. Further studies are also needed to assess whether nonopioid adjuncts can facilitate the change from epidural to systemic analgesia (typically on the 2nd or 3rd postoperative day) and reduce opioid consumption during the days after catheter removal. Fast-track surgery is a multi-model process, and every step in this process needs to be fine-tuned to yield best results (Langelotz 2005). Until now studies have compared only groups with either epidural or systemic analgesia, but for optimal recovery a sequential approach with a combination of both is probably a better choice. A typical multimodal analgesia regimen after removal of an epidural at our institution consists of acetaminophen and ibuprofen. Opioids are avoided if possible, but are added if needed. An improved non-opioid analgesia regimen is a sought-after goal in this fast-track-phase. The study is controlled in terms of the type of surgery (laparoscopic colon and rectal surgery) and all factors of the multimodal analgesia treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
81
Arcoxia® over encapsulated 120 mg; Perioperatively 6 days 1 tablet (Arcoxia® 120 mg) for oral use
P Tablet White Lichtenstein over encapsulated; Perioperatively 6 days 1 tablet for oral use
St. Hedwig Kliniken Berlin GmbH, Department of Anesthesiology and Intensive Care Medicine
Berlin, State of Berlin, Germany
Department of Anesthesiology, Sana-Klinikum Lichtenberg, Oskar-Ziethen-Krankenhaus
Berlin, State of Berlin, Germany
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum/Campus Charité Mitte, Charité Universitätsmedizin
Berlin, State of Berlin, Germany
Department of Anesthesiology, Johannes Wesling Klinikum Minden Mühlenkreiskliniken (AöR)
Minden, Germany
Primary end point of the study is the average pain level (scale 0-10) in the area of surgery during movement (walking a fixed number of steps) under active epidural analgesia, at the third day following laparoscopic colon or rectal surgery.
To demonstrate that the administration of etoricoxib 120mg additionally to the clinical routine therapy (epidural catheter) reduces the post-operative pain level during movement at the third day after laparoscopic colon or rectal surgery in the fast-track design.
Time frame: Third postoperative day
Post-operative pain level during movement in the first 2 days after laparoscopic colon or rectal surgery.
Time frame: In the first 2 days after laparoscopic colon or rectal surgery
Post-operative pain level during rest in the first 2 days after laparoscopic colon or rectal surgery.
Time frame: In the first 2 days after laparoscopic colon or rectal surgery
Post-operative pain level during rest and movement from the third (one day after epidural catheter removal) until the fifth day after laparoscopic colon or rectal surgery
Time frame: In the first three days after epidural catheter removal
Incidence of pain events and the average pain intensity in body parts outside of the area of operations.
Time frame: In the first three days after epidural catheter removal
Incidence of new organ dysfunctions
Organ dysfunctions (cardiovascular, gastrointestinal, renal, respiratory, cognitive, infective)
Time frame: In the first nine days after laparoscopic colon or rectal surgery
Postoperative LOS
Time frame: Period of hospital stay, an exspected average of seven days
Patients level of satisfaction
Time frame: In the first five days after laparoscopic colon or rectal surgery
Incidence of side effects
Side effects by IMP
Time frame: In the first nine days after laparoscopic colon or rectal surgery
Postoperative intensive care unit stay
Time frame: Period of intensive care unit stay, an exspected average of one day
Amount and frequency of intake of rescue medication
Time frame: In the first five days after laparoscopic colon or rectal surgery
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