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

Study Description

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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 Design

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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

Arms and Interventions

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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

Outcome Measures

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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.

Eligibility Criteria

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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

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

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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

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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
First Posted:	September 14, 2010
Last Update Posted:	September 14, 2010
Last Verified:	September 2010

Additional relevant MeSH terms:

Morphine; Remifentanil; Analgesics, Opioid; Narcotics; Central Nervous System Depressants; Physiological Effects of Drugs; Analgesics	Sensory System Agents; Peripheral Nervous System Agents; Hypnotics and Sedatives; Anesthetics, Intravenous; Anesthetics, General; Anesthetics