Liposomal Bupivacaine Vs Bupivacaine with Dexmedetomidine in Erector Spinae Plane Blocks for Mastectomies

ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUnited States Naval Medical Center, Portsmouth

About this trial

Perform a comparison of effective pain relief duration between liposomal bupivacaine and dexmedetomidine when added to bupivacaine in a block for mastectomy for cancer surgery. The erector spinae plane block is a well-established block that is utilized for post operative pain control for procedures performed on the soft tissue of the chest and chest wall as well as intrathoracic procedures. The goal is comparison of the effective duration of both study groups to determine if there is a significant difference in time and amount of post operative opioids required which admitted to hospital.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients requiring any variation of mastectomy with or without axillary lymph node dissection.

Patient agrees to a peripheral nerve block.

Patient agrees to be a study participant.

APS team believes a peripheral nerve block would be appropriate for the patient after reviewing medical/surgical history.

Disqualifiers

Patient declines a peripheral nerve block.

Patient declines to be a study participant.

APS team believes a peripheral nerve block is not clinically indicated.

Surgeon does not want a peripheral nerve block.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Dexmedetomidine

    Drug

    block duration extension additive

  • Liposomal bupivacaine

    Drug

    Control arm, comparison for block duration with dexmedetomidine

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Liposomal bupivacaine and bupivacaine plain erector spinae plane blockActive comparator 1 intervention
Group B: Bupivacaine plain with dexmedetomidineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Is bupivacaine with dexmedetomidine superior to liposomal bupivacaine in both density and duration?

Control group erector spinae plane block with liposomal bupivacaine is less dense and not as long lasting as bupivacaine with dexmedetomidine experimental group. Will investigate initial visual analog scale (VAS) pain scores to determine how effective the block is after surgery and every 6 hours while in patient. Additionally, calling the patient discharging after 96 hours from the time of the block and collect daily pain scores from the patient. This is to establish which group had best pain scores throughout and longest duration of lowest pain scores.

Time frame
96 hours

Secondary outcomes

1

Evaluate oral milligram of morphine equivalent (MME).

Same control and experimental group assessing for morphine milligram equivalents reduction between groups. Will investigate milligram of morphine equivalent every 6 hours to see how much each group requires. In particular looking for increasing trend in morphine equivalence over time. Additionally, calling the patient discharging after 96 hours from the time of the block and collect daily opioid medications taken by the patient and converting to milligram morphine equivalents. This is to establish which group has taken the least amount of morphine equivalents throughout the duration of the block, as an indication to the duration of optimum benefit of the block.

Time frame
96 hours

Other outcomes

1

Time to first opioid administration

Determine if there is a difference in time to first opioid dose after surgery when block is provided before surgery. To determine if there is a difference in the quality of the block after the surgery requiring earlier administration of opioids, as is expected with less dense block having more increased pain.

Time frame
24 hours

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