Laparoscopic Colectomy
Conditions
Keywords
laparoscopic, colectomy, Fast Track, epidural
Brief 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.
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.
Interventions
PROCEDUREEpidural analgesia
Thoracic epidural analgesia until day 2
PROCEDUREPatient controlled analgesia
Patient controlled analgesia (morphine-based)
Sponsors
University of Lausanne Hospitals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* All patients admitted for elective laparoscopic colonic surgery
Exclusion criteria
* Age \< 18y * No informed consent * Emergency situation * Contraindication for EDA (according to local Anesthesia guidelines)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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)) | 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 |
Secondary
| Measure | Time frame |
|---|---|
| Complication Rate, Peridural Analgesia Failure Rate, Patient Comfort | 30 days |
Countries
Switzerland
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 65 |
| 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. | 57 |
| Total | 122 |
Baseline characteristics
| Characteristic | Patient-controlled Analgesia | Total | Epidural |
|---|---|---|---|
| Age, Continuous | 61.2 years STANDARD_DEVIATION 17.8 | 62.5 years STANDARD_DEVIATION 16.3 | 63.1 years STANDARD_DEVIATION 15.1 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Switzerland | 57 participants | 122 participants | 65 participants |
| Sex: Female, Male Female | 23 Participants | 51 Participants | 28 Participants |
| Sex: Female, Male Male | 34 Participants | 71 Participants | 37 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 65 | 0 / 57 |
| other Total, other adverse events | 0 / 65 | 0 / 57 |
| serious Total, serious adverse events | 13 / 65 | 5 / 57 |
Outcome results
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
Time frame: 30 days
Population: accorindg to intention-to-treat principle
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Epidural | 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)) | 5 days |
| Patient-controlled Analgesia | 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)) | 4 days |
Secondary
Complication Rate, Peridural Analgesia Failure Rate, Patient Comfort
Time frame: 30 days