Spinal Versus Epidural Analgesia in Laparotomic Liver Surgery

Liver Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02647047
• Other study ID #: VAS-LIVER
• Status: Not yet recruiting
• Phase: N/A
• First received: December 15, 2015
• Last updated: January 5, 2016
• Start date: January 2016
• Est. completion date: December 2016

Study information

• Verified date: January 2016
• Source: Ospedale San Raffaele
• Contact: Elena Bignami, M.D.
• Phone: +39.02.2643.4524
• Email: bignami.elena[@]hsr.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Liver Diseases
• Liver Neoplasms
• Neoplasms
• Neoplasms, Second Primary
• Secondary Malignant Neoplasm of Liver

Intervention

Procedure:
• Spinal analgesia
Administration of morphine 0.2 mg in subarachnoid space.
• 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
• Transversus Abdominis Plane block
Administration of ropivacaine 0.375% 20 mL in the plane between the internal oblique and the transversus abdominis muscles, bilaterally
• 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
• Ketorolac
Administration of a non-steroidal antinflammatory drug (ketorolac 30 mg) as a rescue therapy
• Ropivacaine
Epidural bolus of ropivacaine 0.2% 4-6 mL followed by continuous epidural infusion of ropivacaine 0.2% 99 mL
• Sufentanil
Epidural continuous epidural infusion of sufentanil 50 mcg/mL 1 mL
• 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
• Ropivacaine
Infiltration of the surgical wound with ropivacaine 0.75% 10- 20 mL

Locations

Country	Name	City	State
Italy	Ospedale San Raffaele	Milano	MI

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale San Raffaele

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	Ready to discharge status	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	Yes