Comparing the Outcome of Two Intraoperative Analgesia Techniques After Hepato-pancreato-biliary Surgery
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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 |
- postoperative pain [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
Pain will be assessed 72 hours post-operatively by:
- A subjective visual analogue pain score (VAS, scale 0-10 cm) during rest, while coughing.
- Time to first postoperative request of analgesia (from IV PCA).
- Cumulative postoperative analgesia consumption (demand/delivery ratio).
- Need for supplementary of alternative analgesia
- 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 |
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| Contact: Idit Matot, professor | 97236974758 | iditm@tasmc.health.gov.il |
| Contact: Miri Davidovich | 97236974758 | mirid@tasmc.health.gov.il |
| 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 | |
| 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, Opioid Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotics Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General Anesthetics |
ClinicalTrials.gov processed this record on May 23, 2013