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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01201499
First received: September 13, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

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 Intervention
Pain
Analgesia
Sedation
Drug: Intrathecal morphine
Drug: Continuous IV remifentanil

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • postoperative pain [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

    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:
  • Recovery and adverse effects [ Time Frame: 72 hours ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 140
Study Start Date: November 2010
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01201499

Contacts
Contact: Idit Matot, professor 97236974758 iditm@tasmc.health.gov.il
Contact: Miri Davidovich 97236974758 mirid@tasmc.health.gov.il

Locations
Israel
Tel-Aviv Sourasky Medical Center Not yet recruiting
Tel-Aviv, Israel, 64239
Contact: Idit Matot, professor    97236974758    iditm@tasmc.health.gov.il   
Contact: Miri Davidovich    97236974758    mirid@tasmc.health.gov.il   
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
Investigators
Study Chair: Idit Matot, professor Tel-Aviv Sourasky Medical Center
Principal Investigator: Elena Parladansky, MD Tel-Aviv Sourasky Medical Center
  More Information

No publications provided

Responsible Party: Professor Idit Matot. Chair, Department of Anesthsiology & Intensive Care, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01201499     History of Changes
Other Study ID Numbers: TASMC-10-IM-0073-CTIL
Study First Received: September 13, 2010
Last Updated: September 13, 2010
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Morphine
Remifentanil
Analgesics
Analgesics, Opioid
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Narcotics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014