Open Colorectal SurgeryPhase 4NCT00915265
Continuous Preperitoneal Infusion of Local Anesthetic (CPA) Versus Epidural Infusion of Local Anesthetic (EA) in Fast-Track Open Colorectal Surgery
A Phase 4 study testing Multilobed catheter (group CPA) and Multilobed catheter (group EA) in people with Open Colorectal Surgery and Early Rehabilitation After Surgery, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The purpose of this study is to compare the continuous preperitoneal infusion of local anesthetic and continuous epidural analgesia for postoperative pain management in fast-track open colorectal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Colorectal Surgery, Early Rehabilitation After Surgery
- What is being tested?
- Multilobed catheter (group CPA) and Multilobed catheter (group EA)
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2009to Oct 2018
- 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
- Age > 18 years
- Open colorectal surgery through a midline incision with a primary anastomosis
- American Society of Anesthesiologists (ASA) physical status I to III
Who cannot join
- Obesity (body mass index > 35 kg/m2)
- Pregnancy
- Inflammatory bowel diseases
- Contraindication for epidural analgesia (patient refusal, active sepsis, coagulopathy)
- Chronic renal failure (with creatinin clearance < 30 ml/min)
- Significant hepatic failure (prothrombin ratio < 50%, factor V < 50%)
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- Chronic pain
- Preoperative opioid consumption
- Preoperative cognitive dysfunction
- Preoperative psychiatric disorders
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU Clermont-Ferrand
Clermont-Ferrand, 63003
Patrick Lacarin, 0473751195, placarin@chu-clermontferrand.fr
About this study
Official title: Continuous Preperitoneal Versus Epidural Infusion of Local Anesthetic for Enhanced Postoperative Recovery Following Open Colorectal Surgery
The purpose of this study is to compare the continuous preperitoneal infusion of local anesthetic and continuous epidural analgesia for postoperative pain management in fast-track open colorectal surgery.
Read the detailed description
Optimized pain relief allowing early mobilization is a prerequisite for enhanced recovery after surgery. Open colorectal surgery is associated with severe and prolonged postoperative pain, especially during mobilization. No analgesic technique has fulfilled all requirements of optimal efficacy: no side effects, low costs, high patient compliance, and improvement in outcome, and consequently, multimodal analgesic techniques have been introduced with a focus on opioid sparing to improve analgesia and recovery. Epidural analgesia (EA) has shown a marked benefit in controlling pain at mobilization, and significantly improves pain management when compared with systemic patient-controlled morphine analgesia. However, eligible patients may not benefit from it because of technical problems or failure of efficiency. Recently, continuous preperitoneal infusion of local anesthetic (CPA) has been shown to be an effective method to relief pain after open colorectal surgery, to reduced morphine consumption and accelerated postoperative recovery. However, this technique has never been evaluated in a fast-track program (ERAS protocol). Moreover, continuous preperitoneal infusions of local anesthetic and epidural analgesia have never been compared.
The purpose of this randomized and double-blinded study is to compare these two techniques on pain control during mobilization, as a prerequisite for enhanced recovery after open colorectal surgery: 1- CPA group: continuous preperitoneal administration of 0.2% ropivacaine using a multilobed catheter positioned between the previously closed parietal peritoneum and the underside of the transversalis fascia + intravenous morphine (patient-controlled analgesia, PCA) as a rescue; 2- EA group: epidural infusion of 0.2% ropivacaine (patient-controlled epidural analgesia, PCEA) + continuous preperitoneal administration of 0.9% saline.
- Being tested
- Multilobed catheter (group CPA), Multilobed catheter (group EA)
- Keywords
- Epidural analgesia, Continuous preperitoneal analgesia, Surgery, Open colorectal surgery, Fast-track surgery, ERAS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multilobed catheter (group CPA)Other
- CPA group: continuous preperitoneal administration of 0.2% ropivacaine using a multilobed catheter positioned between the previously closed parietal peritoneum and the underside of the transversalis fascia
Multilobed catheter (group EA)Other
EA group : thoracic epidural infusion of 0.2 % ropivacaine
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measured at mobilization (defined as pain experienced during transition from supine to the sitting position) using the visual analogue pain scale (VAS) from 0 (no pain) to 10 (worst pain imaginable), at 24 hour after tracheal extubation (H0)
Measured: at 24 hour after tracheal extubation (H0)
Secondary outcomes (1)
Duration of Post-Anesthesia Care Unit (PACU) stay
Measured: in the post-anesthesia care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2009 (estimated)
- Study startOct 2009
- Primary completionJul 2018 (estimated)
- Study completionOct 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Open Colorectal SurgeryStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel FUTIER, MD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915265
- Sponsor's protocol ID
- CHU-0052
- Status last verified
- Jan 2018
- First submitted
- 5 Jun 2009
- Last updated
- 31 Jan 2018
- Results posted
- No
Publications
Jouve P, Bazin JE, Petit A, Minville V, Gerard A, Buc E, Dupre A, Kwiatkowski F, Constantin JM, Futier E. Epidural versus continuous preperitoneal analgesia during fast-track open colorectal surgery: a randomized controlled trial. Anesthesiology. 2013 Mar;118(3):622-30. doi: 10.1097/ALN.0b013e3182800d94.
PubMed 23426208
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Preperitoneal Versus Epidural Infusion of Local Anesthetic for Enhanced Postoperative Recovery Following Open Colorectal Surgery
- ClinicalTrials.gov ID
- NCT00915265
- Acronym / sponsor ID
- CHU-0052
- Keywords
- Epidural analgesia, Continuous preperitoneal analgesia, Surgery, Open colorectal surgery, Fast-track surgery, ERAS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Oct 2018 (estimated)
- First posted
- 8 Jun 2009 (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.
The purpose of this study is to compare the continuous preperitoneal infusion of local anesthetic and continuous epidural analgesia for postoperative pain management in fast-track open colorectal surgery.
Detailed description
Optimized pain relief allowing early mobilization is a prerequisite for enhanced recovery after surgery. Open colorectal surgery is associated with severe and prolonged postoperative pain, especially during mobilization. No analgesic technique has fulfilled all requirements of optimal efficacy: no side effects, low costs, high patient compliance, and improvement in outcome, and consequently, multimodal analgesic techniques have been introduced with a focus on opioid sparing to improve analgesia and recovery. Epidural analgesia (EA) has shown a marked benefit in controlling pain at mobilization, and significantly improves pain management when compared with systemic patient-controlled morphine analgesia. However, eligible patients may not benefit from it because of technical problems or failure of efficiency. Recently, continuous preperitoneal infusion of local anesthetic (CPA) has been shown to be an effective method to relief pain after open colorectal surgery, to reduced morphine consumption and accelerated postoperative recovery. However, this technique has never been evaluated in a fast-track program (ERAS protocol). Moreover, continuous preperitoneal infusions of local anesthetic and epidural analgesia have never been compared.
The purpose of this randomized and double-blinded study is to compare these two techniques on pain control during mobilization, as a prerequisite for enhanced recovery after open colorectal surgery: 1- CPA group: continuous preperitoneal administration of 0.2% ropivacaine using a multilobed catheter positioned between the previously closed parietal peritoneum and the underside of the transversalis fascia + intravenous morphine (patient-controlled analgesia, PCA) as a rescue; 2- EA group: epidural infusion of 0.2% ropivacaine (patient-controlled epidural analgesia, PCEA) + continuous preperitoneal administration of 0.9% saline.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years
- Open colorectal surgery through a midline incision with a primary anastomosis
- American Society of Anesthesiologists (ASA) physical status I to III
Key exclusion criteria (10 listed)
- Obesity (body mass index > 35 kg/m2)
- Pregnancy
- Inflammatory bowel diseases
- Contraindication for epidural analgesia (patient refusal, active sepsis, coagulopathy)
- Chronic renal failure (with creatinin clearance < 30 ml/min)
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 |
|---|---|---|
| Multilobed catheter (group CPA)- CPA group: continuous preperitoneal administration of 0.2% ropivacaine using a multilobed catheter positioned between the previously closed parietal peritoneum and the underside of the transversalis fascia | Other | – |
| Multilobed catheter (group EA)EA group : thoracic epidural infusion of 0.2 % ropivacaine | Other | – |
Primary outcome
Pain measured at mobilization (defined as pain experienced during transition from supine to the sitting position) using the visual analogue pain scale (VAS) from 0 (no pain) to 10 (worst pain imaginable), at 24 hour after tracheal extubation (H0)
Time frame: at 24 hour after tracheal extubation (H0)
1 secondary outcome
Duration of Post-Anesthesia Care Unit (PACU) stay
Time frame: in the post-anesthesia care unit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
- Derived from this study: PubMed 23426208Jouve P, Bazin JE, Petit A, Minville V, Gerard A, Buc E, Dupre A, Kwiatkowski F, Constantin JM, Futier E. Epidural versus continuous preperitoneal analgesia during fast-track open colorectal surgery: a randomized controlled trial. Anesthesiology. 2013 Mar;118(3):622-30. doi: 10.1097/ALN.0b013e3182800d94.
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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.
Emmanuel FUTIER, MD principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Multilobed catheter (group CPA) and Multilobed catheter (group EA) in people with Open Colorectal Surgery and Early Rehabilitation After Surgery, run by University Hospital, Clermont-Ferrand at 1 site in France.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick Lacarin (04.73.75.11.95, placarin@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain measured at mobilization (defined as pain experienced during transition from supine to the sitting position) using the visual analogue pain scale (VAS) from 0 (no pain) to 10 (worst pain imaginable), at 24 hour after tracheal extubation (H0) (time frame: at 24 hour after tracheal extubation (H0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00915265, which also lists 1 linked publication.
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 31 Jan 2018.