Spinal Versus Epidural Analgesia in Laparotomic Liver Surgery

January 5, 2016 updated by: Elena Bignami, Ospedale San Raffaele

Spinal Analgesia Versus Epidural Analgesia in Minor Laparotomic Liver Surgery in an Enhanced Recovery Programme: A Randomized Controlled Trial

The purpose of this study is to evaluate the efficacy of spinal analgesia for minor laparotomic hepatectomy compared with epidural analgesia, monitoring visual analog scale (VAS). The investigators expect at least the same post-operative pain control in the two groups (non inferiority of pain control with spinal analgesia compared to epidural analgesia). Second endpoint is to verify whether after spinal analgesia there is a decrease in patient's length of hospitalization according to enhanced recovery after surgery (ERAS) principles.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Liver surgery is performed under general anesthesia. Loco-regional analgesia is generally performed before general anesthesia induction to obtain the best post-operative pain control,in association with intravenous analgesic drug administration.

For minor laparotomic surgery (defined as the resection of up to three hepatic segments), if not contraindicated, in our hospital loco-regional analgesia is performed through the placement of a thoracic (T7-T8 or T8-T9) epidural catheter in which a local anesthetic (usually ropivacaine) and an opioid (usually sufentanil) are administered for the first three post-operative days. This is still considered the gold-standard for pain management in this surgery. In our institute, there is a dedicated acute pain service (APS) for pain management in the post-operative period. APS is also responsible for monitoring, registering and treating all side effects related to both the procedure and the drugs used.

In laparoscopic abdominal surgery, instead of epidural analgesia, if not contraindicated, spinal analgesia with low dose morphine before general anesthesia induction is performed. This technique is actually considered efficacy and safe in these type of surgeries.

The investigators therefore decided to test the efficacy of spinal analgesia versus epidural analgesia for minor liver surgery since anterior hepatic segments resection is less painful than major liver surgery because it requires less liver manipulation without significant involvement of the Glisson's capsule. This might imply a less incidence of procedure-related side effects such as post-dural puncture headache or site infections. Moreover, spinal analgesia may allow a earlier post-operative patients mobilization and thus a earlier hospital discharge.

In this randomized controlled trial, the investigators therefore aim to randomize 40 consecutive patients into 2 arms. The experimental group will receive spinal analgesia (morphine 0.2 mg) for post-operative pain control while the control group will receive epidural analgesia (bolus of ropivacaine 0.2% 4-6 mL followed by continuous epidural infusion of ropivacaine 0.2%: 99 mL + sufentanil 50 mcg/mL: 1 mL).

Randomization will be performed with closed opaque envelopes. During surgery, patients will be monitored as usual. Intraoperative blood losses and fluids administration will be recorded.

Patients randomized into the epidural group will not receive local anesthetic administration through the epidural catheter during the hepatic resection phase to avoid hemodynamic instability. Once the hepatic resection phase is finished and euvolemic status is recovered, epidural analgesia will be administered as mentioned before.

In patients in the spinal group, transversus abdominis plane (TAP) block with ropivacaine 0.375% 20 mL bilaterally or surgical wound infiltration with ropivacaine 0.75% 10- 20 mL will also be performed before anesthesia recovery.

In both groups, post-operative pain control will be managed with intravenous acetaminophen 1000 mg 40 minutes before ending of surgery followed by intravenous administration of acetaminophen 1000 mg every 8 hours and a non-steroidal antinflammatory drug (ketorolac 30 mg) as a rescue therapy in the post-operative period if not contraindicated.

Patients will be monitored every 24 hours until the achievement of the "ready to discharge" status defined as:

  • appropriate oral alimentation;
  • optimal pain control with drugs administered orally;
  • adequate ability in walking and personal care;
  • clinical, laboratory and instrumental absence of any post-operative complication;
  • intestinal function recovery;
  • patient consent to discharge.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • MI
      • Milano, MI, Italy, 20132
        • Ospedale San Raffaele
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 18 years old
  • Hospitalized patients
  • Surgical indication for minor laparotomic anterior liver resection (II, III, IV and V hepatic segment resection)
  • Surgical indication for laparotomic liver metastasectomy
  • Ability to provide an informed consent

Exclusion Criteria:

  • Patient refusal to provide informed consent
  • Chronical therapy with opioids
  • Pregnancy or breastfeeding
  • Alcohol or drug abuse
  • Planned or unplanned post-operative intensive care unit admission
  • Contraindication to spinal/epidural analgesia
  • Severe liver or renal failure
  • Cognitive disorders, mental retard or psychiatric disorders
  • Allergy to any drug used

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Spinal
Patients will receive spinal analgesia (morphine 0.2 mg) before general anesthesia for minor laparotomic liver resection.
Procedure: Spinal analgesia
Administration of morphine 0.2 mg in subarachnoid space.
Procedure: Transversus Abdominis Plane block
Administration of ropivacaine 0.375% 20 mL in the plane between the internal oblique and the transversus abdominis muscles, bilaterally
Procedure: Surgical wound infiltration
Infiltration of the surgical wound with ropivacaine 0.75% 10- 20 mL
Drug: Acetaminophen
Administration of 1000 mg of acetaminophen 40 minutes before ending of surgery followed by intravenous administration of 1000 mg every 8 hours
Drug: Ketorolac
Administration of a non-steroidal antinflammatory drug (ketorolac 30 mg) as a rescue therapy
Drug: Ropivacaine
Epidural bolus of ropivacaine 0.2% 4-6 mL followed by continuous epidural infusion of ropivacaine 0.2% 99 mL
Drug: Ropivacaine
Administration of ropivacaine 0.375% 20 mL in the plane between the internal oblique and the transversus abdominis muscles, bilaterally to obtain the transversus abdominis plane block
Drug: Ropivacaine
Infiltration of the surgical wound with ropivacaine 0.75% 10- 20 mL
ACTIVE_COMPARATOR: Epidural
Patients will receive epidural analgesia (bolus of ropivacaine 0.2% 4-6 mL followed by continuous epidural infusion of ropivacaine 0.2% 99 mL + sufentanil 50 mcg/mL 1 mL) before general anesthesia for minor laparotomic liver resection.
Drug: Acetaminophen
Administration of 1000 mg of acetaminophen 40 minutes before ending of surgery followed by intravenous administration of 1000 mg every 8 hours
Drug: Ketorolac
Administration of a non-steroidal antinflammatory drug (ketorolac 30 mg) as a rescue therapy
Drug: Ropivacaine
Epidural bolus of ropivacaine 0.2% 4-6 mL followed by continuous epidural infusion of ropivacaine 0.2% 99 mL
Drug: Ropivacaine
Administration of ropivacaine 0.375% 20 mL in the plane between the internal oblique and the transversus abdominis muscles, bilaterally to obtain the transversus abdominis plane block
Drug: Ropivacaine
Infiltration of the surgical wound with ropivacaine 0.75% 10- 20 mL
Procedure: Epidural analgesia
Bolus of ropivacaine 0.2% 4-6 mL followed by continuous epidural infusion of ropivacaine 0.2% 99 mL + sufentanil 50 mcg/mL 1 mL in epidural space
Drug: Sufentanil
Epidural continuous epidural infusion of sufentanil 50 mcg/mL 1 mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of postoperative pain control by mean of the visual analog scale early after surgery
Time Frame: Within 1 hour after surgery
Visual analog scale (VAS) will be assessed and compared between the two groups.
Within 1 hour after surgery
Assessment of postoperative pain control by mean of the visual analog scale six hours after surgery
Time Frame: 6 hours after surgery
Visual analog scale (VAS) will be assessed and compared between the two groups.
6 hours after surgery
Assessment of postoperative pain control by mean of the visual analog scale one day after surgery
Time Frame: 24 hours after surgery
Visual analog scale (VAS) will be assessed and compared between the two groups.
24 hours after surgery
Assessment of postoperative pain control by mean of the visual analog scale two days after surgery
Time Frame: 48 hours after surgery
Visual analog scale (VAS) will be assessed and compared between the two groups.
48 hours after surgery
Assessment of postoperative pain control by mean of the visual analog scale three days after surgery
Time Frame: 72 hours after surgery
Visual analog scale (VAS) will be assessed and compared between the two groups.
72 hours after surgery
Assessment of postoperative pain control by mean of the visual analog scale at hospital discharge
Time Frame: Up to 30 days after surgery
Visual analog scale (VAS) will be assessed and compared between the two groups.
Up to 30 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ready to discharge status
Time Frame: Up to 30 days after surgery
The postoperative day in which patients reach the "ready to discharge" status will be recorded and compared between the two groups.
Up to 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ospedale San Raffaele

Investigators

  • Principal Investigator: Raffaella Reineke, M.D., Ospedale San Raffaele

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (ANTICIPATED)

November 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

December 15, 2015

First Submitted That Met QC Criteria

January 5, 2016

First Posted (ESTIMATE)

January 6, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

January 6, 2016

Last Update Submitted That Met QC Criteria

January 5, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VAS-LIVER

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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