Comparing the Outcome of Two Intraoperative Analgesia Techniques After Hepato-pancreato-biliary Surgery
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Pain Analgesia Sedation||Drug: Intrathecal morphine Drug: Continuous IV remifentanil||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
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
- postoperative pain [ Time Frame: 72 hours ]
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 ]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.
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 ClinicalTrials.gov identifier (NCT number): NCT01201499
|Contact: Idit Matot, firstname.lastname@example.org|
|Contact: Miri Davidovichemail@example.com|
|Tel-Aviv Sourasky Medical Center|
|Tel-Aviv, Israel, 64239|
|Contact: Idit Matot, professor 97236974758 firstname.lastname@example.org|
|Contact: Miri Davidovich 97236974758 email@example.com|
|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|