Spinal Versus Epidural Analgesia in Laparotomic Liver Surgery

Summary

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.

Conditions

• Secondary Malignant Neoplasm of Liver
• Liver Diseases
• Liver Neoplasms

Interventions

PROCEDURE

Spinal analgesia

Administration of morphine 0.2 mg in subarachnoid space.

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

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

Sufentanil

Epidural continuous epidural infusion of sufentanil 50 mcg/mL 1 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

Sponsors & Collaborators

• Ospedale San Raffaele

  lead OTHER

Principal Investigators

• Raffaella Reineke, M.D. · Ospedale San Raffaele

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-31

Primary Completion

2016-11-30

Completion

2016-12-31

Countries

• Italy

Study Locations