Spinal Versus Epidural Analgesia in Laparotomic Liver Surgery

NCT02647047 | Unknown DMC

• 1 other identifier: VAS-LIVER
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

spinal analgesia; epidural analgesia; laparotomic liver resection; ERAS; length of stay

Outcome Measures

Primary Outcomes (6)

• Assessment of postoperative pain control by mean of the visual analog scale early 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

  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

  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

  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

  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

  Visual analog scale (VAS) will be assessed and compared between the two groups.

  Up to 30 days after surgery

Secondary Outcomes (1)

• Ready to discharge status

  Up to 30 days after surgery

Study Arms (2)

Spinal

EXPERIMENTAL

Patients will receive spinal analgesia (morphine 0.2 mg) before general anesthesia for minor laparotomic liver resection.

Procedure: Spinal analgesia; Procedure: Transversus Abdominis Plane block; Procedure: Surgical wound infiltration; Drug: Acetaminophen; Drug: Ketorolac; Drug: Ropivacaine

Epidural

ACTIVE COMPARATOR

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.

Procedure: Epidural analgesia; Drug: Acetaminophen; Drug: Ketorolac; Drug: Ropivacaine; Drug: Sufentanil

Interventions

Spinal analgesia PROCEDURE

Administration of morphine 0.2 mg in subarachnoid space.

Spinal

Epidural analgesia PROCEDURE

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

Epidural

Transversus Abdominis Plane block PROCEDURE

Administration of ropivacaine 0.375% 20 mL in the plane between the internal oblique and the transversus abdominis muscles, bilaterally

Spinal

Surgical wound infiltration PROCEDURE

Infiltration of the surgical wound with ropivacaine 0.75% 10- 20 mL

Spinal

Acetaminophen DRUG

Administration of 1000 mg of acetaminophen 40 minutes before ending of surgery followed by intravenous administration of 1000 mg every 8 hours

Epidural; Spinal

Ketorolac DRUG

Administration of a non-steroidal antinflammatory drug (ketorolac 30 mg) as a rescue therapy

Epidural; Spinal

Ropivacaine DRUG

Epidural bolus of ropivacaine 0.2% 4-6 mL followed by continuous epidural infusion of ropivacaine 0.2% 99 mL

Epidural

Sufentanil DRUG

Epidural continuous epidural infusion of sufentanil 50 mcg/mL 1 mL

Epidural

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ospedale San Raffaele: lead

Study Sites (1)

Ospedale San Raffaele

Milan, MI, 20132, Italy

Location

Related Publications (6)

• Tzimas P, Prout J, Papadopoulos G, Mallett SV. Epidural anaesthesia and analgesia for liver resection. Anaesthesia. 2013 Jun;68(6):628-35. doi: 10.1111/anae.12191.

  PMID: 23662750 BACKGROUND

• Revie EJ, Massie LJ, McNally SJ, McKeown DW, Garden OJ, Wigmore SJ. Effectiveness of epidural analgesia following open liver resection. HPB (Oxford). 2011 Mar;13(3):206-11. doi: 10.1111/j.1477-2574.2010.00274.x.

  PMID: 21309939 BACKGROUND

• Kasivisvanathan R, Abbassi-Ghadi N, Prout J, Clevenger B, Fusai GK, Mallett SV. A prospective cohort study of intrathecal versus epidural analgesia for patients undergoing hepatic resection. HPB (Oxford). 2014 Aug;16(8):768-75. doi: 10.1111/hpb.12222. Epub 2014 Jan 28.

  PMID: 24467320 BACKGROUND

• Ntinas A, Kardassis D, Konstantinopoulos I, Kottos P, Manias A, Kyritsi M, Zilianiaki D, Vrochides D. Duration of the thoracic epidural catheter in a fast-track recovery protocol may decrease the length of stay after a major hepatectomy: a case control study. Int J Surg. 2013;11(9):882-5. doi: 10.1016/j.ijsu.2013.07.014. Epub 2013 Aug 4.

  PMID: 23924906 BACKGROUND

• Koea JB, Young Y, Gunn K. Fast track liver resection: the effect of a comprehensive care package and analgesia with single dose intrathecal morphine with gabapentin or continuous epidural analgesia. HPB Surg. 2009;2009:271986. doi: 10.1155/2009/271986. Epub 2009 Dec 15.

  PMID: 20029637 BACKGROUND

• Hughes MJ, McNally S, Wigmore SJ. Enhanced recovery following liver surgery: a systematic review and meta-analysis. HPB (Oxford). 2014 Aug;16(8):699-706. doi: 10.1111/hpb.12245. Epub 2014 Mar 24.

  PMID: 24661306 BACKGROUND

MeSH Terms

Conditions

Liver Diseases; Liver Neoplasms

Interventions

Analgesia, Epidural; Acetaminophen; Ketorolac; Ropivacaine; Sufentanil

Condition Hierarchy (Ancestors)

Digestive System Diseases; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Fentanyl; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Raffaella Reineke, M.D.

  Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena Bignami, M.D.

CONTACT

+39.02.2643.4524; bignami.elena@hsr.it

Raffaella Reineke, M.D.

CONTACT

reineke.raffaella@hsr.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: December 15, 2015
• First Posted: January 6, 2016
• Study Start: January 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 6, 2016

Record last verified: 2016-01

Locations

IT (1)