Post-operative PainPhase 4NCT01259830
Effectiveness of Etoricoxib as an Additive Analgesic to Epidural Analgesia in Colon or Rectal Fast-track Surgery
A Phase 4 study testing Arcoxia®120 mg and P Tablet White Lichtenstein in people with Post-operative Pain, run by Claudia Spies at 4 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- Arcoxia®120 mg and P Tablet White Lichtenstein
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 4 sitesGermany
- Study dates
- Mar 2011to Apr 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
St. Hedwig Kliniken Berlin GmbH, Department of Anesthesiology and Intensive Care Medicine
Berlin, State of Berlin, 10115
Department of Anesthesiology, Sana-Klinikum Lichtenberg, Oskar-Ziethen-Krankenhaus
Berlin, State of Berlin, 10365
Department of Anesthesiology and Intensive Care Medicine, Campus Virchow Klinikum/Campus Charité Mitte, Charité Universitätsmedizin
Berlin, State of Berlin, 13353
Department of Anesthesiology, Johannes Wesling Klinikum Minden Mühlenkreiskliniken (AöR)
Minden, 32429
About this study
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
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.
Read more
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.
Read the 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
- Being tested
- Arcoxia®120 mg, P Tablet White Lichtenstein
- Keywords
- fast-track, colon or rectal surgery, pain relief
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arcoxia®120 mgDrug
Also called Etoricoxib
Arcoxia® over encapsulated 120 mg; Perioperatively 6 days 1 tablet (Arcoxia® 120 mg) for oral use
P Tablet White LichtensteinDrug
P Tablet White Lichtenstein over encapsulated; Perioperatively 6 days 1 tablet for oral use
| Study group | Role | What they receive |
|---|---|---|
| Arcoxia® 120 mg | Experimental | Not described Receives: Drug: Arcoxia®120 mg |
| Sugar pill | Placebo comparator | Not described Receives: Drug: P Tablet White Lichtenstein |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Third postoperative day
Secondary outcomes (10)
Post-operative pain level during movement in the first 2 days after laparoscopic colon or rectal surgery.
Measured: 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.
Measured: 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
Measured: 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.
Measured: In the first three days after epidural catheter removal
Incidence of new organ dysfunctions
Organ dysfunctions (cardiovascular, gastrointestinal, renal, respiratory, cognitive, infective)
Measured: In the first nine days after laparoscopic colon or rectal surgery
Postoperative LOS
Measured: Period of hospital stay, an exspected average of seven days
Patients level of satisfaction
Measured: In the first five days after laparoscopic colon or rectal surgery
Incidence of side effects
Side effects by IMP
Measured: In the first nine days after laparoscopic colon or rectal surgery
Postoperative intensive care unit stay
Measured: Period of intensive care unit stay, an exspected average of one day
Amount and frequency of intake of rescue medication
Measured: In the first five days after laparoscopic colon or rectal surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2010 (estimated)
- Study startMar 2011
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claudia Spies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Claudia Spies, Charite University, Berlin, Germany
- Investigators
- Claudia Spies, MD, Prof., Study director, Dept. of Anesthesiology and Intensive Care, Charité, Universitätsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01259830
- Sponsor's protocol ID
- Etoricoxib-fast-track
- Status last verified
- May 2014
- First submitted
- 13 Dec 2010
- Last updated
- 23 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01259830
- Acronym / sponsor ID
- Etoricoxib-fast-track
- Conditions
- Post-operative Pain
- Keywords
- fast-track, colon or rectal surgery, pain relief
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Claudia SpiesUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 14 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arcoxia® 120 mg | Experimental | Drug: Arcoxia®120 mg |
| Sugar pill | Placebo comparator | Drug: P Tablet White Lichtenstein |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (17 listed)
- ASA status IV-V
- allergy against etoricoxib, other components or other NSAID
- coronary heart disease
- heart insufficiency NYHA II-IV
- cerebrovascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arcoxia®120 mgAlso: EtoricoxibArcoxia® over encapsulated 120 mg; Perioperatively 6 days 1 tablet (Arcoxia® 120 mg) for oral use | Drug | Arcoxia® 120 mg |
| P Tablet White LichtensteinP Tablet White Lichtenstein over encapsulated; Perioperatively 6 days 1 tablet for oral use | Drug | Sugar pill |
Primary outcome
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
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.
10 secondary outcomes
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
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
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Claudia Spies, MD, Prof. study director
Dept. of Anesthesiology and Intensive Care, Charité, Universitätsmedizin Berlin
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Arcoxia®120 mg and P Tablet White Lichtenstein in people with Post-operative Pain, run by Claudia Spies at 4 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2014.