Laparoscopic ColectomyEVANCT00508300
Epidural Analgesia (EDA) Versus Patient Controlled Analgesia (PCA) in Laparoscopic Colon Surgery
A study testing Epidural analgesia in people with Laparoscopic Colectomy, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial summary
The purpose of this study is to determine whether a epidural analgesia versus patient controlled analgesia reduces the medical recovery in patients undergoing elective laparoscopic colon surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Colectomy
- What is being tested?
- Epidural analgesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2010to Oct 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- All patients admitted for elective laparoscopic colonic surgery
Who cannot join
- Age < 18y
- No informed consent
- Emergency situation
- Contraindication for EDA (according to local Anesthesia guidelines)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department of Visceral Surgery, University Hospital CHUV, Lausanne
Lausanne, 1011
About this study
Official title: Epidural Analgesia (EDA) Versus Patient Controlled Analgesia (PCA) in Laparoscopic Colon Surgery: A Monocentric Controlled Non-blinded Randomized Superiority Trial
The purpose of this study is to determine whether a epidural analgesia versus patient controlled analgesia reduces the medical recovery in patients undergoing elective laparoscopic colon surgery.
Read the detailed description
Allocation by individual random number generated by a computer program to either EDA or PCA for 48h after laparoscopic colonic surgery.
Short, both groups are treated according to a recent Fast track protocol. Group A will preoperatively receive a mid thoracic EDA (th 8-9; naropine 0,1%) while group B will receive a PCA (morphine) postoperatively. Both EDA and PCA are removed the afternoon at day 2. Patients with a non-functioning EDA within the first 24h will be crossed over to the PCA group.
- Conditions
- Laparoscopic Colectomy
- Being tested
- Epidural analgesia, Patient controlled analgesia
- Keywords
- laparoscopic, colectomy, Fast Track, epidural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural analgesiaProcedure or surgery
Thoracic epidural analgesia until day 2
Patient controlled analgesiaProcedure or surgery
Patient controlled analgesia (morphine-based)
| Study group | Role | What they receive |
|---|---|---|
| A | Other | Epidural Analgesia (EDA) An epidural catheter was inserted at thoracic level (Th8-Th10) before induction of anesthesia. A bolus of 5 mL of bupivacaine 0.5% was started as soon as the epidural catheter was in place, and a continuous perfusion of bupivacaine 0.5% at 5 mL/hr was initiated until the end of surgical procedure. Receives: Procedure: Epidural analgesia |
| B | Other | Patient controlled analgesia (PCA) was assured by fentanyl (morphine-based) as needed. Receives: Procedure: Patient controlled analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Medical Recovery (Defined as Pain Sufficient Controlled by Oral Analgesia, Fully Mobile Patients or at Least as Mobile as at Admission and Tolerance of the Patient of Oral Food Intake (More Than 2/3 of Daily Meal))
Medical recovery was chosen as primary end point and was defined as the fulfillment of all the 3 following criteria: (1) sufficient pain control by oral analgesics, (2) fully mobilized or at least comparable with preoperative status, and (3) tolerance of oral food that was defined as two thirds or more of normal meal (hospital portion).23 Medical recovery was considered as more specific outcome parameter than hospital stay because social and logistic factors were not interfering.24,25
Measured: 30 days
Secondary outcomes (1)
Complication Rate, Peridural Analgesia Failure Rate, Patient Comfort
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2007 (estimated)
- Study startJan 2010
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic ColectomyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nicolas DEMARTINES, University of Lausanne Hospitals
- Investigators
- Nicolas Demartines, MD, Study chair, Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00508300
- Sponsor's protocol ID
- P166/07
- Acronym
- EVA
- Status last verified
- Jul 2020
- First submitted
- 26 Jul 2007
- Last updated
- 11 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Hubner M, Blanc C, Roulin D, Winiker M, Gander S, Demartines N. Randomized clinical trial on epidural versus patient-controlled analgesia for laparoscopic colorectal surgery within an enhanced recovery pathway. Ann Surg. 2015 Apr;261(4):648-53. doi: 10.1097/SLA.0000000000000838.
PubMed 25119117
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Analgesia (EDA) Versus Patient Controlled Analgesia (PCA) in Laparoscopic Colon Surgery: A Monocentric Controlled Non-blinded Randomized Superiority Trial
- ClinicalTrials.gov ID
- NCT00508300
- Acronym / sponsor ID
- EVA / P166/07
- Conditions
- Laparoscopic Colectomy
- Keywords
- laparoscopic, colectomy, Fast Track, epidural
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 27 Jul 2007 (estimated)
- Results
- Posted 25 Feb 2019
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 determine whether a epidural analgesia versus patient controlled analgesia reduces the medical recovery in patients undergoing elective laparoscopic colon surgery.
Detailed description
Allocation by individual random number generated by a computer program to either EDA or PCA for 48h after laparoscopic colonic surgery.
Short, both groups are treated according to a recent Fast track protocol. Group A will preoperatively receive a mid thoracic EDA (th 8-9; naropine 0,1%) while group B will receive a PCA (morphine) postoperatively. Both EDA and PCA are removed the afternoon at day 2. Patients with a non-functioning EDA within the first 24h will be crossed over to the PCA group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Other | Procedure: Epidural analgesiaEpidural Analgesia (EDA) An epidural catheter was inserted at thoracic level (Th8-Th10) before induction of anesthesia. A bolus of 5 mL of bupivacaine 0.5% was started as soon as the epidural catheter was in place, and a continuous perfusion of bupivacaine 0.5% at 5 mL/hr was initiated until the end of surgical procedure. |
| B | Other | Procedure: Patient controlled analgesiaPatient controlled analgesia (PCA) was assured by fentanyl (morphine-based) as needed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients admitted for elective laparoscopic colonic surgery
Key exclusion criteria (4 listed)
- Age < 18y
- No informed consent
- Emergency situation
- Contraindication for EDA (according to local Anesthesia guidelines)
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 |
|---|---|---|
| Epidural analgesiaThoracic epidural analgesia until day 2 | Procedure or surgery | A |
| Patient controlled analgesiaPatient controlled analgesia (morphine-based) | Procedure or surgery | B |
Primary outcome
Medical Recovery (Defined as Pain Sufficient Controlled by Oral Analgesia, Fully Mobile Patients or at Least as Mobile as at Admission and Tolerance of the Patient of Oral Food Intake (More Than 2/3 of Daily Meal))
Time frame: 30 days
Medical recovery was chosen as primary end point and was defined as the fulfillment of all the 3 following criteria: (1) sufficient pain control by oral analgesics, (2) fully mobilized or at least comparable with preoperative status, and (3) tolerance of oral food that was defined as two thirds or more of normal meal (hospital portion).23 Medical recovery was considered as more specific outcome parameter than hospital stay because social and logistic factors were not interfering.24,25
1 secondary outcome
Complication Rate, Peridural Analgesia Failure Rate, Patient Comfort
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25119117Hubner M, Blanc C, Roulin D, Winiker M, Gander S, Demartines N. Randomized clinical trial on epidural versus patient-controlled analgesia for laparoscopic colorectal surgery within an enhanced recovery pathway. Ann Surg. 2015 Apr;261(4):648-53. doi: 10.1097/SLA.0000000000000838.
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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.
Nicolas Demartines, MD study chair
Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epidural analgesia in people with Laparoscopic Colectomy, run by University of Lausanne Hospitals at 1 site in Switzerland.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 11 Aug 2020. 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 Switzerland. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Medical Recovery (Defined as Pain Sufficient Controlled by Oral Analgesia, Fully Mobile Patients or at Least as Mobile as at Admission and Tolerance of the Patient of Oral Food Intake (More Than 2/3 of Daily Meal)) (time frame: 30 days). 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 NCT00508300, 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 11 Aug 2020.