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

NCT ID: NCT01259830

Last Updated: 2014-05-23

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2014-04-30

Brief Summary

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.

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.

Conditions

Post-operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Arcoxia® 120 mg

Group Type: EXPERIMENTAL

Arcoxia®120 mg

Intervention Type: DRUG

Arcoxia® over encapsulated 120 mg; Perioperatively 6 days 1 tablet (Arcoxia® 120 mg) for oral use

Sugar pill

Group Type: PLACEBO_COMPARATOR

P Tablet White Lichtenstein

Intervention Type: DRUG

P Tablet White Lichtenstein over encapsulated; Perioperatively 6 days 1 tablet for oral use

Interventions

Arcoxia®120 mg

Arcoxia® over encapsulated 120 mg; Perioperatively 6 days 1 tablet (Arcoxia® 120 mg) for oral use

Intervention Type: DRUG

P Tablet White Lichtenstein

P Tablet White Lichtenstein over encapsulated; Perioperatively 6 days 1 tablet for oral use

Intervention Type: DRUG

Other Intervention Names

Etoricoxib

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Claudia Spies

OTHER

Sponsor Role: lead

Responsible Party

Claudia Spies

Prof. MD, Director of the Dept. of Anesthesiology and Intensive Care Medicine, CVK, CCM, Charite University, Berlin, Germany

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Claudia Spies, MD, Prof.

Role: STUDY_DIRECTOR

Dept. of Anesthesiology and Intensive Care, Charité, Universitätsmedizin Berlin

Locations

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

Countries

Germany

Other Identifiers

Etoricoxib-fast-track

Identifier Type: -

Identifier Source: org_study_id