Spinal Versus Epidural Analgesia in Laparotomic Liver Surgery

Sponsor

Ospedale San Raffaele (Other)

Overall Status

Unknown status

CT.gov ID

NCT02647047

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Secondary Malignant Neoplasm of Liver Liver Diseases Liver Neoplasms	Procedure: Spinal analgesia Procedure: Epidural analgesia Procedure: Transversus Abdominis Plane block Procedure: Surgical wound infiltration Drug: Acetaminophen Drug: Ketorolac Drug: Ropivacaine Drug: Sufentanil Drug: Ropivacaine Drug: Ropivacaine	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jan 1, 2016

Anticipated Primary Completion Date :

Nov 1, 2016

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

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 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.	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: 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

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

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.

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: 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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Ready to discharge status [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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