Effectiveness of Etoricoxib as an Additive Analgesic to Epidural Analgesia in Colon or Rectal Fast-track Surgery

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Claudia Spies, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01259830
First received: December 13, 2010
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Post-operative Pain
Drug: Arcoxia®120 mg
Drug: P Tablet White Lichtenstein
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized, Placebo Controlled Study to Evaluate the Effectiveness of Etoricoxib as an Additive Analgesic to Epidural Analgesia in Colon or Rectal Fast-track Surgery

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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. [ Time Frame: Third postoperative day ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Incidence of new organ dysfunctions [ Time Frame: In the first nine days after laparoscopic colon or rectal surgery ] [ Designated as safety issue: No ]
    Organ dysfunctions (cardiovascular, gastrointestinal, renal, respiratory, cognitive, infective)

  • Postoperative LOS [ Time Frame: Period of hospital stay, an exspected average of seven days ] [ Designated as safety issue: No ]
  • Patients level of satisfaction [ Time Frame: In the first five days after laparoscopic colon or rectal surgery ] [ Designated as safety issue: No ]
  • Incidence of side effects [ Time Frame: In the first nine days after laparoscopic colon or rectal surgery ] [ Designated as safety issue: Yes ]
    Side effects by IMP

  • Postoperative intensive care unit stay [ Time Frame: Period of intensive care unit stay, an exspected average of one day ] [ Designated as safety issue: No ]
  • Amount and frequency of intake of rescue medication [ Time Frame: In the first five days after laparoscopic colon or rectal surgery ] [ Designated as safety issue: No ]

Enrollment: 81
Study Start Date: March 2011
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arcoxia® 120 mg Drug: Arcoxia®120 mg
Arcoxia® over encapsulated 120 mg; Perioperatively 6 days 1 tablet (Arcoxia® 120 mg) for oral use
Other Name: Etoricoxib
Placebo Comparator: Sugar pill Drug: P Tablet White Lichtenstein
P Tablet White Lichtenstein over encapsulated; Perioperatively 6 days 1 tablet for oral use

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • aged 18 or over
  • written informed consent
  • no inclusion in other medical studies according to the AMG (German drug law) during the study period
  • realization of colon or rectal surgery in the fast track design after clinical standards including an epidural catheter

Exclusion Criteria:

  • ASA status IV-V
  • allergy against etoricoxib, other components or other NSAID
  • coronary heart disease
  • heart insufficiency NYHA II-IV
  • cerebrovascular disease
  • peripheral arterial occlusive disease
  • untreated arterial hypertonus
  • active peptic ulcera or active gastrointestinal bleeding
  • minor to severe liver dysfunction (beginning from Child - Plugh - Classification A)
  • kidney insufficiency
  • inflammatory bowel disease
  • pregnancy (positive hCG laboratory test) or lactation
  • Women of child-bearing potential who are not using a highly effective contraception method with a pearl-index < 1 during study participation and for at least 3 consecutive months after study inclusion.
  • placement in an institution on order of an official authority
  • missing consent for saving and passing on pseudonymous data
  • hereditary galactose-intolerance, lactase deficit, glucose-galactose-malabsorption
  • no correct epidural catheter placement within 48 h after surgery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01259830

Locations
Germany
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum/Campus Charité Mitte, Charité Universitätsmedizin
Berlin, Germany, 13353
Department of Anesthesiology, Sana-Klinikum Lichtenberg, Oskar-Ziethen-Krankenhaus
Berlin, Germany, 10365
St. Hedwig Kliniken Berlin GmbH, Department of Anesthesiology and Intensive Care Medicine
Berlin, Germany, 10115
Department of Anesthesiology, Johannes Wesling Klinikum Minden Mühlenkreiskliniken (AöR)
Minden, Germany, 32429
Sponsors and Collaborators
Claudia Spies
Investigators
Study Director: Claudia Spies, MD, Prof. Dept. of Anesthesiology and Intensive Care, Charité, Universitätsmedizin Berlin
  More Information

No publications provided

Responsible Party: Claudia Spies, Prof. MD, Director of the Dept. of Anesthesiology and Intensive Care Medicine, CVK, CCM, Charite University, Berlin, Germany, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01259830     History of Changes
Other Study ID Numbers: Etoricoxib-fast-track
Study First Received: December 13, 2010
Last Updated: May 22, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
fast-track
colon or rectal surgery
pain relief

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Analgesics
Etoricoxib
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Cyclooxygenase 2 Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents

ClinicalTrials.gov processed this record on September 18, 2014