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Cesarean Delivery – Infiltration
This case study represents an individual clinician experience with and methodology for using EXPAREL.
Pacira BioSciences, Inc., recognizes that there are other methodologies for administering local anesthetics, as well as individual patient considerations, when selecting the dose for a specific procedure.
Please see Important Safety Information below and refer to the Full Prescribing Information.
Disclosure: Dr Cherot is a paid consultant for Pacira BioSciences, Inc.
Background
CASE INFORMATION
Physician Name
Elizabeth Cherot, MD, MBA
Affiliation
Obstetrician and Gynecologist
Axia Women’s Health, Voorhees, NJ
Brunswick Hills Obstetrics & Gynecology, East Brunswick, NJ
Axia Women’s Health, Voorhees, NJ
Brunswick Hills Obstetrics & Gynecology, East Brunswick, NJ
Surgical Case Performed
Cesarean delivery
Inpatient or Outpatient Procedure
Inpatient
PATIENT CHARACTERISTICS
Gender
Female
Age
34 years
Patient History
and Characteristics
and Characteristics
39 weeks gestation, weight 165 lb, blood pressure 130/80 mm Hg
Past obstetric history includes 1 live birth via cesarean delivery due to breech presentation and 1 miscarriage at 8 weeks gestation
Past obstetric history includes 1 live birth via cesarean delivery due to breech presentation and 1 miscarriage at 8 weeks gestation
PROCEDURAL DETAILS
Incision Size
12-cm Joel-Cohen
Intraoperative Anesthesia
Combined spinal/epidural anesthesia: hyperbaric bupivacaine 0.75% 13.5 mg
+ morphine 150 mcg + fentanyl 15 mcg
+ morphine 150 mcg + fentanyl 15 mcg
Dose of EXPAREL and
Total Volume Used
Total Volume Used
MULTIMODAL ANALGESIA AND ENHANCED RECOVERY AFTER SURGERY PROTOCOL
Preoperative Medications Used
At least 2 hours before the procedure: IV cefazolin 1 g, IV dexamethasone 10 mg,
IV ondansetron 4 mg, TD scopolamine patch
IV ondansetron 4 mg, TD scopolamine patch
Intraoperative Medications Used
80 mL of expanded EXPAREL
Postoperative Medications Used
First 24 hours postoperatively: IV acetaminophen 1000 mg, IV ketorolac 15 mg; patient initiated on a postoperative diet
Up to 72 hours postoperatively and through discharge: PO acetaminophen 650 mg q6h*,
PO ibuprofen 600 mg q6h*
Up to 72 hours postoperatively and through discharge: PO acetaminophen 650 mg q6h*,
PO ibuprofen 600 mg q6h*
IV=intravenous; PO=by mouth; q6h=every 6 hours; TD=transdermal.
*Dose intervals were designed so patient received alternating doses of PO acetaminophen or PO ibuprofen every 3 hours.
ASSESSED THE SIZE OF THE SURGICAL SITE AND DEPTH OF TISSUE, THEN PREPARED INJECTION MATERIALS ACCORDINGLY
In this procedure, Dr Cherot determined a total volume of 80 mL would be needed to cover the surgical site. She expanded 20 mL of EXPAREL® (bupivacaine liposome injectable suspension) with 24 mL of bupivacaine HCl 0.5% and 36 mL of normal saline. Bupivacaine HCl was added to provide early-onset analgesia and bridge the time to onset of the long-acting local analgesia provided by EXPAREL.
In cases that require a higher total volume, such as those involving larger incisions, Dr Cherot may add normal saline to increase the total volume to 100 mL.
The recommended dose of EXPAREL for infiltration in adults is based on the size of the surgical site, the volume required to cover the area, and individual patient factors that may impact the safety of an amide local anesthetic. The maximum dose of EXPAREL should not exceed 266 mg. The recommended dose of EXPAREL for patients aged 6 to <17 years old is 4 mg/kg, up to a maximum of 266 mg. The recommended dose of EXPAREL in adults for interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa, and adductor canal is 133 mg. The recommended dose of EXPAREL in adults for adductor canal block is 133 mg (10 mL) admixed with 50 mg (10 mL) of 0.5% bupivacaine HCl, for a total volume of 20 mL.
EXPAREL can be administered unexpanded (20 mL) or expanded to increase volume up to a total of 300 mL (final concentration of 0.89 mg/mL [ie, 1:14 dilution by volume]) with normal (0.9%) saline or lactated Ringer’s solution.
Bupivacaine HCl (which is approved for use in patients aged 12 and older) may be administered immediately before EXPAREL or admixed in the same syringe, as long as the ratio of the milligram dose of bupivacaine HCl to EXPAREL does not exceed 1:2. Admixing may impact the pharmacokinetic and/or physicochemical properties of EXPAREL, and this effect is concentration dependent. The toxic effects of these drugs are additive and their administration should be used with caution, including monitoring for neurological and cardiovascular effects related to local anesthetic systemic toxicity. Other than with bupivacaine, EXPAREL should not be admixed with other drugs prior to administration.
DIVIDED INJECTATE INTO SYRINGES WITH NEEDLE SIZES APPROPRIATE FOR INFILTRATION (20- TO 25-GAUGE) AND PLANNED WHICH AREAS TO INFILTRATE WITH EACH INJECTION
For this procedure, Dr Cherot divided the injectate into four 20-mL syringes with 22-gauge needles.
AFTER CLOSURE OF THE UTERUS AND PERITONEUM
Step #1: Rectus abdominis muscle
Dr Cherot began by infiltrating 40 mL of expanded EXPAREL® (bupivacaine liposome injectable suspension) bilaterally into the anterior rectus abdominis muscle and rectus sheath. She infiltrated 20 mL of EXPAREL on each side, injecting parallel to the surgical plane in a fan-like pattern. Dr Cherot delivered approximately 5 mL of EXPAREL deep into the tissue with each injection to ensure optimal coverage of the area. She infiltrated as she moved the needle to optimize coverage with the EXPAREL admixture. She then reapproximated the fascia before continuing with the remaining infiltration steps.
FIGURE 1. Rectus abdominis muscle
With a moving needle technique, the injections were spread in a fan-like pattern and occurred as the needle was withdrawn to maximize the coverage area.
AFTER REAPPROXIMATION OF THE FASCIA
Step #2: Fascia and subcutaneous tissue
Next, Dr Cherot infiltrated 20 mL of EXPAREL bilaterally from the corners of the fascial incision site. She infiltrated in a fan-like pattern, delivering 3 to 4 mL of EXPAREL with each injection, for a total of 10 mL on each side. Dr Cherot infiltrated above and below the fascia and into the subcutaneous tissue, parallel and along the natural lateral descending curvature of the fascial plane. She infiltrated out toward the iliohypogastric and ilioinguinal nerves as well as the obliques, where aponeurosis begins to form the rectus sheath.
FIGURE 2. Fascia and subcutaneous tissue
AFTER SKIN CLOSURE
Step #3: Bilateral field block
Finally, Dr Cherot performed bilateral field blocks, infiltrating 2 fingerbreadths superior and medial to the anterior superior iliac crest. She infiltrated 10 mL of EXPAREL on each side, perpendicular to the surgical plane, making sure to deliver EXPAREL deep into the abdominal wall. This step provides a field block of the ilioinguinal nerves, addressing pain from any innervation closer to the incision.
FIGURE 3. Bilateral field block
Surgical Site Infiltration in C-SectionPerformed by: Dr Cherot
ASP, average sales price; CMS, Centers for Medicare and Medicaid Services.
Important Notice
- This site is intended to provide medical and product information to health care professionals in the United States.
- To report an adverse event, email drugsafety@pacira.com or call 1-855-793-9727.
- For medical inquiries related to EXPAREL, submit a request to Medical Information or call 1-855-793-9727.
- These are not all of the potential important safety considerations for EXPAREL; please see the full Prescribing Information.
Indication
EXPAREL® (bupivacaine liposome injectable suspension) is indicated to produce postsurgical local analgesia via infiltration in patients aged 6 years and older and regional analgesia in adults via an interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa, and an adductor canal block. Safety and efficacy have not been established in other nerve blocks.
Important Safety Information
- EXPAREL is contraindicated in obstetrical paracervical block anesthesia.
- Adverse reactions reported in adults with an incidence greater than or equal to 10% following EXPAREL administration via infiltration were nausea, constipation, and vomiting; adverse reactions reported in adults with an incidence greater than or equal to 10% following EXPAREL administration via nerve block were nausea, pyrexia, headache, and constipation.
- Adverse reactions with an incidence greater than or equal to 10% following EXPAREL administration via infiltration in pediatric patients six to less than 17 years of age were nausea, vomiting, constipation, hypotension, anemia, muscle twitching, vision blurred, pruritus, and tachycardia.
- Do not admix lidocaine or other non-bupivacaine local anesthetics with EXPAREL. EXPAREL may be administered at least 20 minutes or more following local administration of lidocaine.
- EXPAREL is not recommended to be used in the following patient populations: patients <6 years old for infiltration, patients younger than 18 years old for nerve blocks, and/or pregnant patients.
- Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease.
Warnings and Precautions Specific to EXPAREL
- Avoid additional use of local anesthetics within 96 hours following administration of EXPAREL.
- EXPAREL is not recommended for the following types or routes of administration: epidural, intrathecal, regional nerve blocks other than interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa, and adductor canal block, or intravascular or intra-articular use.
- The potential sensory and/or motor loss with EXPAREL is temporary and varies in degree and duration depending on the site of injection and dosage administered and may last for up to 5 days, as seen in clinical trials.
Warnings and Precautions for Bupivacaine-Containing Products
- Central Nervous System (CNS) Reactions: There have been reports of adverse neurologic reactions with the use of local anesthetics. These include persistent anesthesia and paresthesia. CNS reactions are characterized by excitation and/or depression.
- Cardiovascular System Reactions: Toxic blood concentrations depress cardiac conductivity and excitability, which may lead to dysrhythmias, sometimes leading to death.
- Allergic Reactions: Allergic-type reactions (eg, anaphylaxis and angioedema) are rare and may occur as a result of hypersensitivity to the local anesthetic or to other formulation ingredients.
- Chondrolysis: There have been reports of chondrolysis (mostly in the shoulder joint) following intra-articular infusion of local anesthetics, which is an unapproved use.
- Methemoglobinemia: Cases of methemoglobinemia have been reported with local anesthetic use.
Please refer to full Prescribing Information.
SEE MORE
EXPAREL® (bupivacaine liposome injectable suspension) is indicated to produce postsurgical local analgesia via infiltration
