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

NCT01201499 | Unknown DMC

• 1 other identifier: TASMC-10-IM-0073-CTIL
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Analgesia; Sedation

Outcome Measures

Primary Outcomes (1)

• postoperative pain

  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

  72 hours

Secondary Outcomes (1)

• Recovery and adverse effects

  72 hours

Study Arms (2)

Intrathecal morphine

ACTIVE COMPARATOR

A single shot of intrathecal morphine given before the induction of general anesthesia. Followed by postoperative IV patient-controlled morphine analgesia.

Drug: Intrathecal morphine

Continuous IV remifentanil

ACTIVE COMPARATOR

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

Interventions

Intrathecal morphine DRUG

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.

Also known as: ITM

Intrathecal morphine

Continuous IV remifentanil DRUG

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.

Also known as: IVR

Continuous IV remifentanil

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel-Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Pain; Agnosia

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Idit Matot, professor

  Tel-Aviv Sourasky Medical Center

  STUDY CHAIR

• Elena Parladansky, MD

  Tel-Aviv Sourasky Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Idit Matot, professor

CONTACT

97236974758; iditm@tasmc.health.gov.il

Miri Davidovich

CONTACT

97236974758; mirid@tasmc.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: September 13, 2010
• First Posted: September 14, 2010
• Study Start: November 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: January 1, 2012
• Last Updated: September 14, 2010

Record last verified: 2010-09

Locations

IL (1)