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Comparing the Outcome of Two Intraoperative Analgesia Techniques After Hepato-pancreato-biliary Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01201499
Recruitment Status : Unknown
Verified September 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : September 14, 2010
Last Update Posted : September 14, 2010
Information provided by:
Tel-Aviv Sourasky Medical Center

Brief Summary:
Inadequate pain control after abdominal procedures may lead to adverse postoperative outcome. Epidural analgesia is currently an accepted technique in abdominal surgery, but its use has been limited in liver resections by postoperative coagulation disturbances and the possible increased risk of bleeding complications, including spinal hematoma. A range of alternative analgesic techniques can be used for major liver or pancreatic resections, including intrathecal morphine (single shot) administered immediately before surgery, and continuous administration of intravenous (IV) short-acting opioids, such as remifentanil, plus a single bolus of IV morphine. Postoperatively analgesia may be obtained by patient-controlled morphine analgesia (IV PCA). Both protocols have been demonstrated to provide satisfactory postoperative pain relief, and each has its unique advantages. However, to this end there is no data in the literature to show benefit from one regimen over the other. We therefore wish to determine whether there is a difference in analgesic efficacy between the two techniques, as optimizing perioperative pain relief in this rapidly expanding surgical field is of utmost importance. Our hypothesis is that continuous intraoperative IV analgesia with remifentanil followed by IV PCA morphine is not inferior to intrathecal morphine with respect to analgesia and ambulation outcome, and may provide an alternative, non-invasive intraoperative analgesic technique.

Condition or disease Intervention/treatment Phase
Pain Analgesia Sedation Drug: Intrathecal morphine Drug: Continuous IV remifentanil Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Impact of Two Different Intraoperative Analgesia Techniques on Post-operative Outcome After Hepato-pancreato-biliary Surgery
Study Start Date : November 2010
Estimated Primary Completion Date : November 2011
Estimated Study Completion Date : January 2012

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Arm Intervention/treatment
Active Comparator: Intrathecal morphine
A single shot of intrathecal morphine given before the induction of general anesthesia. Followed by postoperative IV patient-controlled morphine analgesia.
Drug: Intrathecal morphine
a single dose of intrathecal morphine (ITM, 4 µcg/kg, or ~0.1-0.3 mg morphine before induction of general anesthesia, followed by postoperative patient-controlled morphine analgesia (IV-PCA) for postoperative pain.
Other Name: ITM

Active Comparator: Continuous IV remifentanil
Continuous administration of IV remifentanil during surgery, supported by a single bolus of IV morphine at the end of surgery. Followed by postoperative IV patient-controlled morphine analgesia.
Drug: Continuous IV remifentanil
a continuous infusion of IV remifentanil supported by a single bolus of IV morphine, 0.2 mg/kg at the end of surgery, followed by IV-PCA morphine.
Other Name: IVR

Primary Outcome Measures :
  1. postoperative pain [ Time Frame: 72 hours ]

    Pain will be assessed 72 hours post-operatively by:

    1. A subjective visual analogue pain score (VAS, scale 0-10 cm) during rest, while coughing.
    2. Time to first postoperative request of analgesia (from IV PCA).
    3. Cumulative postoperative analgesia consumption (demand/delivery ratio).
    4. Need for supplementary of alternative analgesia

Secondary Outcome Measures :
  1. Recovery and adverse effects [ Time Frame: 72 hours ]
    Secondary outcomes will include: levels of sedation, length of time with indwelling urinary catheter, time to ambulation (sitting, walking), length of stay in the intensive care unit (ICU) and total length of hospitalization, time to extubation, need for re-intubation and analgesia-related adverse effects.

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

ASA physical status I-III patients (> 18 years old), scheduled for elective liver resection, pancreatic resection or pancreaticoduodenectomy ("Whipple" procedure) at Tel Aviv-Sourasky Medical Center.

Exclusion Criteria:

Contraindications to the spinal technique, allergy to the study drugs, patients treated with opioids for chronic pain, patients with obstructive sleep apnea, morbidly obese patients, pregnant women, patient requiring mechanical ventilation at the end of surgery.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01201499

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Contact: Idit Matot, professor 97236974758
Contact: Miri Davidovich 97236974758

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Tel-Aviv Sourasky Medical Center
Tel-Aviv, Israel, 64239
Contact: Idit Matot, professor    97236974758   
Contact: Miri Davidovich    97236974758   
Sub-Investigator: Yifat Klein, PhD         
Sub-Investigator: Richard Nakache, MD         
Sub-Investigator: Mendy Ben-Haim, MD         
Sub-Investigator: Amir Szold, MD         
Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
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Study Chair: Idit Matot, professor Tel-Aviv Sourasky Medical Center
Principal Investigator: Elena Parladansky, MD Tel-Aviv Sourasky Medical Center
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Responsible Party: Professor Idit Matot. Chair, Department of Anesthsiology & Intensive Care, Tel-Aviv Sourasky Medical Center Identifier: NCT01201499    
Other Study ID Numbers: TASMC-10-IM-0073-CTIL
First Posted: September 14, 2010    Key Record Dates
Last Update Posted: September 14, 2010
Last Verified: September 2010
Additional relevant MeSH terms:
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Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents