Morbid ObesityPhase 2/3NCT01249872
Patients-Controlled Epidural Analgesia After Gastric Bypass for Morbid Obesity Using Morphine-Levobupivacaine Regimens
A Phase 2/3 study testing GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE, GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE and GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE in people with Morbid Obesity and Postoperative Pain, run by University of Patras at 1 site in Greece.
Trial summary
Adequate postoperative analgesia can facilitate recovery following gastric bypass surgery for morbid obesity. The efficacy and safety of intravenous patient - controlled analgesia has been studied, but up to date no data are available concerning the use of thoracic epidural patient-controlled analgesia regarding the… Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Morbid Obesity, Postoperative Pain, Postoperative Bowel Function
- What is being tested?
- GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE, GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE and GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2010to Sep 2012
- Phase
- Phase 2/3
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Body mass index (BMI) > 50
- Age < 50
- Patients written consent to participate in the study
Who cannot join
- Cardiovascular disease (valvular and ischemic heart disease)
- Patients refusal to participate in the study
- Contraindication to epidural catheter placement (e.g anticoagulation, anti- platelets medication)
- Active psychiatric disease requiring treatment
- Redo surgery
Trial locations and contacts
1 site in 1 country.
Greece1 site
University of Patras, Department of Anesthesiology and Critical Care Medicine
Pátrai, Achaia, 26500
About this study
Official title: Postoperative Thoracic Epidural Analgesia in Super Obese Patients (~BMI 60 kg m-2) Undergoing Open Weight Loss Surgery :Does the Addition of Morphine to 0.1% and 0.2% Levobupivacaine Affect Postoperative Pain Relief, Perioperative Lung Function, Return of Normal Gastrointestinal Mobility and Ambulation?
Adequate postoperative analgesia can facilitate recovery following gastric bypass surgery for morbid obesity. The efficacy and safety of intravenous patient - controlled analgesia has been studied, but up to date no data are available concerning the use of thoracic epidural patient-controlled analgesia regarding the use of levobupivacaine combined with morphine in morbidly obese patients. The investigators' aim in this prospective, randomized, double-blinded study was to compare the analgesic effectiveness, the dose requirements and side effects of thoracic epidural patient controlled analgesia 0.1% and 0.2% levobupivacaine combined with a continuous epidural administration of morphine, with or without a loading dose, after open gastric bypass for morbid obesity.
Read the detailed description
Morbidly obese patients (BMI > 50 kg/m2) planned to undergo open variant of biliopancreatic diversion with Roux-en-Y gastric bypass (BPD-RYGBP) received standardized general anesthesia (intravenous propofol combined with remifentanyl and muscle relaxation). Preoperatively, in all patients an epidural catheter in the thoracic spine level will be placed between T5 and T8 interspace. All patients will be randomly allocated to six groups:
Group A patients will receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation patient controlled epidural anesthesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) , combined with a continuous epidural infusion of morphine 0.2 mg/h will be administered, Group B patients will receive an epidural bolus dose of 1mg of morphine intra-operatively (45 min before the estimated end of the surgery) and postoperatively the same levobupivacaine and morphine regimen as Group A, Group C patients will receive an epidural bolus dose 2 mg of morphine intra-operatively and thereafter the same levobupivacaine and morphine regimen as Group A.
Group D patients will receive intra-operatively an epidural bolus dose of 2 ml of normal saline. Postoperatively, the patients will receive PCEA in a dose of 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h, Group E patients will receive intra-operatively an epidural bolus dose of 1mg of morphine intra-operatively and postoperatively the same regimen as Group D.
Group F patients will receive intra-operatively an epidural bolus dose of 2 mg of morphine intra-operatively and thereafter the same regimen as Group D.
Pain assessment will be performed using visual analogue scale (VAS, 10cm scale) at rest, at mobilization and at cough. Furthermore, total local anesthetic and morphine consumption, side effects on cardiovascular, respiratory and gastrointestinal systems, including blood pressure,blood gases, spirometric values Forced Expiratory Volume at 1 sec (FEV1), Forced Vital Capacity (FVC), Peak Expiratory Flow Rate (PEFR), incidents of postoperative nausea and vomiting (PONV), pruritus, time to first flatus, postoperative ambulation will be recorded for up to 6 days.
- Conditions
- Morbid Obesity, Postoperative Pain, Postoperative Bowel Function, Postoperative Ambulation
- Being tested
- GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE, GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE, GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE, GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE, GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE
- Keywords
- open gastric by-pass, super morbidly obese patients, postoperative thoracic epidural analgesia, different drug regimens (morphine and levobupivacaine), Lung function tests, Postoperative Bowel recovery, Postoperative Ambulation
- Medical subject headings
- Obesity, Morbid, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINEDrug
Also called Morfina cloridrato 10 mg /ml - Morphine, Chirocaine 5 mg/ml - Levobupivacaine
Patients receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA) of 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINEDrug
Also called Morfina cloridrato 10 mg /ml - Morphine, Chirocaine 5 mg/ml - Levobupivacaine
Patients receive intraoperatively(45 min before the estimated end of the surgery)an epidural bolus dose of 1mg of morphine.Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA) of 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINEDrug
Also called Morfina cloridrato 10 mg /ml - Morphine, Chirocaine 5 mg/ml - Levobupivacaine
Patients receive intraoperatively (45 min before the estimated end of the surgery) a bolus dose 2 mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA) of 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINEDrug
Also called Morfina cloridrato 10 mg /ml - Morphine, Chirocaine 5 mg/ml - Levobupivacaine
Patients receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2 ml of normal saline epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA) of 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINEDrug
Also called Morfina cloridrato 10 mg /ml - Morphine, Chirocaine 5 mg/ml - Levobupivacaine
Patients receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally.Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA) of 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINEDrug
Also called Morfina cloridrato 10 mg /ml - Morphine, Chirocaine 5 mg/ml - Levobupivacaine
Patients receive an epidural bolus dose of 2 mg of morphine intra-operatively (45 min before the estimated end of the surgery).Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA) of 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
| Study group | Role | What they receive |
|---|---|---|
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | Active comparator | Group A patients receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline. Postoperatively, patients receive PCEA of 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h. Receives: Drug: GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE |
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | Active comparator | Group B patients receive an epidural bolus dose of 1mg of morphine intra-operatively (45 min before the estimated end of the surgery). Postoperatively, patients receive PCEA of 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h Receives: Drug: GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE |
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | Active comparator | Group C patients receive an epidural bolus dose 2 mg of morphine intra-operatively (45 min before the estimated end of the surgery).Postoperatively, patients receive PCEA of 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h Receives: Drug: GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE |
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Active comparator | Group D patients receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2 ml of normal saline, epidurally. Postoperatively,patients receive PCEA of 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h Receives: Drug: GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE |
| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | Active comparator | Group E patients receive intra-operatively (45 min before the estimated end of the surgery) an epidural bolus dose of 1mg of morphine.Postoperatively, patients receive PCEA of 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h Receives: Drug: GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE |
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Active comparator | Group F patients receive intra-operatively (45 min before the estimated end of the surgery) an epidural bolus dose of 2 mg of morphine. Postoperatively, patients receive PCEA of 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h Receives: Drug: GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Pain Scores (Visual Analogue Scale)
Pain scores at rest and on cough using a 10cm Visual Analogue Scale(0=no pain, 10=worst possible pain) were assessed up to 48h postoperatively.
Measured: up to 48 h postoperatively
Secondary outcomes (5)
Time to Postoperative Bowel Recovery
Time to postoperative recovery of bowel function assessed by first flatus or stool, noticed by the patient
Measured: up to 6 days
Time to First Postoperative Ambulation
Time to being able to walk without assistance within the room or outside the room
Measured: up to 6 days
Consumption of Levobupivacaine at 24h and 48 h Postoperatively
Cumulative consumption of levobupivacaine administered via patients controlled epidural analgesia pump( PCEA) at 24h and 48 h postoperatively
Measured: up to 48 hours postoperatively
Cumulative Consumption of Epidural Morphine at 24h and 48h Postoperatively
Cumulative consumption of epidural morphine administered as loading dose, intraoperatively, of 1mg(groups B and E)or 2mg (groups C and F) and as continuous infusion of 0,2mg/h ( all groups) at 24h and 48h postoperatively.All participants in each Group received the same dose of epidural morphine, as no participant missed a scheduled dose.
Measured: up to 48 hours postoperatively
Change From Baseline of Spirometric Values
Preoperatively, after a detailed demonstration, baseline spirometry measurements of forced vital capacity (FVC), forced expiratory volume in 1 s (FEV1) and peak expiratory flow rate (PEFR) were measured, using a bedside spirometer (PowerCubeΤΜ, Ganshorn Medizin Electronic, Germany), on-line connected to a PC. Spirometry was standardized with each patient in a 30o head-up position and it was performed at least three times and the best measurement was recorded, according to the criteria of the European Respiratory Society .Postoperatively, spirometric values (FVC= Forced Vital Capacity, FEV1=Forced Expiratory Volume at 1 sec , PEFR= Peak Expiratory Flow Rate)were recorded at 12, 24, 36, 48, 72, 144 hours . Data are expressed as percentage of preoperative values, which are 100%.
Measured: up to 6th day postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2010 (estimated)
- Study startJan 2010
- Primary completionAug 2012
- Study completionSep 2012
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.
- Other trials for Morbid ObesityStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Patras
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zotou Natassa,MD, University of Patras
- Investigators
- KRITON S FILOS, MD, PhD, PROFESSOR, Study chair, Department of Anesthesiology and Critical CareATHINA SIAMPALIOTH, MD, Study director, University Hospital of PatrasANASTASIA ZOTOU, MD, Principal investigator, University Hospital of Patras
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01249872
- Sponsor's protocol ID
- morbid obesity_post-op pain
- Status last verified
- Jun 2013
- First submitted
- 22 Nov 2010
- Last updated
- 24 Jul 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Thoracic Epidural Analgesia in Super Obese Patients (~BMI 60 kg m-2) Undergoing Open Weight Loss Surgery :Does the Addition of Morphine to 0.1% and 0.2% Levobupivacaine Affect Postoperative Pain Relief, Perioperative Lung Function, Return of Normal Gastrointestinal Mobility and Ambulation?
- ClinicalTrials.gov ID
- NCT01249872
- Acronym / sponsor ID
- morbid obesity_post-op pain
- Conditions
- Morbid Obesity, Postoperative Pain, Postoperative Bowel Function, Postoperative Ambulation
- Keywords
- open gastric by-pass, super morbidly obese patients, postoperative thoracic epidural analgesia, different drug regimens (morphine and levobupivacaine), Lung function tests, Postoperative Bowel recovery, Postoperative Ambulation
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of PatrasUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 30 Nov 2010 (estimated)
- Results
- Posted 24 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Adequate postoperative analgesia can facilitate recovery following gastric bypass surgery for morbid obesity. The efficacy and safety of intravenous patient - controlled analgesia has been studied, but up to date no data are available concerning the use of thoracic epidural patient-controlled analgesia regarding the use of levobupivacaine combined with morphine in morbidly obese patients. The investigators' aim in this prospective, randomized, double-blinded study was to compare the analgesic effectiveness, the dose requirements and side effects of thoracic epidural patient controlled analgesia 0.1% and 0.2% levobupivacaine combined with a continuous epidural administration of morphine, with or without a loading dose, after open gastric bypass for morbid obesity.
Detailed description
Morbidly obese patients (BMI > 50 kg/m2) planned to undergo open variant of biliopancreatic diversion with Roux-en-Y gastric bypass (BPD-RYGBP) received standardized general anesthesia (intravenous propofol combined with remifentanyl and muscle relaxation). Preoperatively, in all patients an epidural catheter in the thoracic spine level will be placed between T5 and T8 interspace. All patients will be randomly allocated to six groups:
Group A patients will receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation patient controlled epidural anesthesia (PCEA)with 0.1% levobupivacaine (5ml, lockout interval 10min) , combined with a continuous epidural infusion of morphine 0.2 mg/h will be administered, Group B patients will receive an epidural bolus dose of 1mg of morphine intra-operatively (45 min before the estimated end of the surgery) and postoperatively the same levobupivacaine and morphine regimen as Group A, Group C patients will receive an epidural bolus dose 2 mg of morphine intra-operatively and thereafter the same levobupivacaine and morphine regimen as Group A.
Group D patients will receive intra-operatively an epidural bolus dose of 2 ml of normal saline. Postoperatively, the patients will receive PCEA in a dose of 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h, Group E patients will receive intra-operatively an epidural bolus dose of 1mg of morphine intra-operatively and postoperatively the same regimen as Group D.
Group F patients will receive intra-operatively an epidural bolus dose of 2 mg of morphine intra-operatively and thereafter the same regimen as Group D.
Pain assessment will be performed using visual analogue scale (VAS, 10cm scale) at rest, at mobilization and at cough. Furthermore, total local anesthetic and morphine consumption, side effects on cardiovascular, respiratory and gastrointestinal systems, including blood pressure,blood gases, spirometric values Forced Expiratory Volume at 1 sec (FEV1), Forced Vital Capacity (FVC), Peak Expiratory Flow Rate (PEFR), incidents of postoperative nausea and vomiting (PONV), pruritus, time to first flatus, postoperative ambulation will be recorded for up to 6 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE | Active comparator | Drug: GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINEGroup A patients receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline. Postoperatively, patients receive PCEA of 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h. |
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE | Active comparator | Drug: GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINEGroup B patients receive an epidural bolus dose of 1mg of morphine intra-operatively (45 min before the estimated end of the surgery). Postoperatively, patients receive PCEA of 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h |
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE | Active comparator | Drug: GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINEGroup C patients receive an epidural bolus dose 2 mg of morphine intra-operatively (45 min before the estimated end of the surgery).Postoperatively, patients receive PCEA of 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h |
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Active comparator | Drug: GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINEGroup D patients receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2 ml of normal saline, epidurally. Postoperatively,patients receive PCEA of 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h |
| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE | Active comparator | Drug: GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINEGroup E patients receive intra-operatively (45 min before the estimated end of the surgery) an epidural bolus dose of 1mg of morphine.Postoperatively, patients receive PCEA of 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h |
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE | Active comparator | Drug: GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINEGroup F patients receive intra-operatively (45 min before the estimated end of the surgery) an epidural bolus dose of 2 mg of morphine. Postoperatively, patients receive PCEA of 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) > 50
- Age < 50
- Patients written consent to participate in the study
Key exclusion criteria (5 listed)
- Cardiovascular disease (valvular and ischemic heart disease)
- Patients refusal to participate in the study
- Contraindication to epidural catheter placement (e.g anticoagulation, anti- platelets medication)
- Active psychiatric disease requiring treatment
- Redo surgery
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 |
|---|---|---|
| GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINEAlso: Morfina cloridrato 10 mg /ml - Morphine, Chirocaine 5 mg/ml - LevobupivacainePatients receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA) of 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h. | Drug | GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE |
| GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINEAlso: Morfina cloridrato 10 mg /ml - Morphine, Chirocaine 5 mg/ml - LevobupivacainePatients receive intraoperatively(45 min before the estimated end of the surgery)an epidural bolus dose of 1mg of morphine.Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA) of 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h. | Drug | GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE |
| GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINEAlso: Morfina cloridrato 10 mg /ml - Morphine, Chirocaine 5 mg/ml - LevobupivacainePatients receive intraoperatively (45 min before the estimated end of the surgery) a bolus dose 2 mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA) of 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h. | Drug | GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE |
| GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINEAlso: Morfina cloridrato 10 mg /ml - Morphine, Chirocaine 5 mg/ml - LevobupivacainePatients receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2 ml of normal saline epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA) of 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h. | Drug | GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE |
| GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINEAlso: Morfina cloridrato 10 mg /ml - Morphine, Chirocaine 5 mg/ml - LevobupivacainePatients receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally.Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA) of 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h. | Drug | GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE |
| GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINEAlso: Morfina cloridrato 10 mg /ml - Morphine, Chirocaine 5 mg/ml - LevobupivacainePatients receive an epidural bolus dose of 2 mg of morphine intra-operatively (45 min before the estimated end of the surgery).Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA) of 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h. | Drug | GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE |
Primary outcome
Change From Baseline in Pain Scores (Visual Analogue Scale)
Time frame: up to 48 h postoperatively
Pain scores at rest and on cough using a 10cm Visual Analogue Scale(0=no pain, 10=worst possible pain) were assessed up to 48h postoperatively.
5 secondary outcomes
Time to Postoperative Bowel Recovery
Time frame: up to 6 days
Time to First Postoperative Ambulation
Time frame: up to 6 days
Consumption of Levobupivacaine at 24h and 48 h Postoperatively
Time frame: up to 48 hours postoperatively
Cumulative Consumption of Epidural Morphine at 24h and 48h Postoperatively
Time frame: up to 48 hours postoperatively
Change From Baseline of Spirometric Values
Time frame: up to 6th day postoperatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
KRITON S FILOS, MD, PhD, PROFESSOR study chair
Department of Anesthesiology and Critical Care
ATHINA SIAMPALIOTH, MD study director
University Hospital of Patras
ANASTASIA ZOTOU, MD principal investigator
University Hospital of Patras
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE, GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE and GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE in people with Morbid Obesity and Postoperative Pain, run by University of Patras at 1 site in Greece.
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 5 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 24 Jul 2013. 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 Greece. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jul 2013). 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?
Change From Baseline in Pain Scores (Visual Analogue Scale) (time frame: up to 48 h postoperatively). 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 24 Jul 2013.