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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| B | Other | Patient controlled analgesia (PCA) was assured by fentanyl (morphine-based) as needed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidural analgesia | Procedure | Thoracic epidural analgesia until day 2 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Complication Rate, Peridural Analgesia Failure Rate, Patient Comfort | 30 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicolas Demartines, MD | Department of Visceral Surgery, University Hospital Center, Lausanne, Switzerland | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Visceral Surgery, University Hospital CHUV, Lausanne | Lausanne | 1011 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25119117 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Epidural | Epidural Analgesia (Th 8-9) Epidural analgesia: Thoracic epidural analgesia until day 2 |
| FG001 | Patient-controlled Analgesia | Patient controlled analgesia (morphine-based) Patient controlled analgesia: Patient controlled analgesia (morphine-based) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
128 patients were randomized to receive either EDA (n = 67) or PCA (n = 61) as allocated treatment. Two EDA patients and our PCA patients dropped out after randomization and no patient was lost to follow-up. Final analysis compared therefore 65 EDA patients with 57 PCA patients (Fig. 1).
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| ID | Title | Description |
|---|---|---|
| BG000 | Epidural | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | accorindg to intention-to-treat principle | Posted | Median | Inter-Quartile Range | days | 30 days |
|
Adverse event data were collected until 30 days after surgery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Epidural | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| major complications according to clavien: 3+4 | Surgical and medical procedures | Systematic Assessment | clavien 3+4 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| martin hübner | lausanne university hospital | +41795561506 | martin.hubner@chuv.ch |
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| ID | Term |
|---|---|
| D015360 | Analgesia, Epidural |
| D016058 | Analgesia, Patient-Controlled |
| ID | Term |
|---|---|
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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| Patient controlled analgesia |
| Procedure |
Patient controlled analgesia (morphine-based) |
|
| Patient-controlled Analgesia |
In the PCA group, intravenous PCA was inserted with 1 mg/h. A bolus of 1 mL was allowed at every 5 minutes up to a maximal dose of 40 mg/4h. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Patient-controlled Analgesia | In the PCA group, intravenous PCA was inserted with 1 mg/h. A bolus of 1 mL was allowed at every 5 minutes up to a maximal dose of 40 mg/4h. |
|
|
| Secondary | Complication Rate, Peridural Analgesia Failure Rate, Patient Comfort | Not Posted | 30 days | Participants |
| 2 |
| 65 |
| 13 |
| 65 |
| 0 |
| 65 |
| EG001 | Patient-controlled Analgesia | In the PCA group, intravenous PCA was inserted with 1 mg/h. A bolus of 1 mL was allowed at every 5 minutes up to a maximal dose of 40 mg/4h. | 0 | 57 | 5 | 57 | 0 | 57 |
|
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