ESPBs vs TAPs for Satisfactory Analgesia Following DIEP Surgery
ConditionPain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-70
SponsorUniversity of Kansas Medical Center
About this trial
Breast cancer is the second most common cancer diagnosed in American women . For patients who have undergone surgical mastectomy, autologous breast reconstruction is an alternative option to breast implants. Deep Inferior Epigastric Perforator (DIEP) flaps are the gold standard for autologous breast reconstruction . Effective pain control following surgery is imperative and ultrasound-guided bilateral transversus abdominis plane blocks (TAPs) with the infiltration of local anesthetics, such a ropivacaine are a common regional technique of choice . A newer described technique, bilateral Erector Spinae Plane blocks (ESPBs) (which also are an infiltration of local anesthetic) present as an alternative approach for post-operative analgesia. ESPBs have been proven efficacious in reducing intra- and post-operative opioid requirements, lessening the need for rescue analgesics in other similar surgical procedures.
The hypothesis is that preoperative bilateral ESPBs could provide equivalent pain control as a regional analgesic for patients undergoing DIEP flap surgery when compared to preoperative bilateral TAPs
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adult women with breast cancer, ASA 1-3, undergoing DIEP flap surgery
Disqualifiers
Chronic opioid use contraindications to local anesthetics or regional analgesia Inability to communicate intensity of pain on a numeric analog scale
Trial design
Design model
Parallel
Treatments tested in this trial
Pre-operative Erector Spinae Plane block prior to DIEP surgery
Procedure/SurgeryAfter obtaining informed consent to participate in the study, patients will be randomized by a computer 50/50 to either the Erector Spinae Plane group or the Transversus Abdominus Plane group at the time of their surgical clinic visit prior to their scheduled surgery. Then on the morning of surgery, the Erector Spinae Plane group will receive a bilateral ultrasound-guided Erector Spinae Plane peripheral nerve block. During this intervention, 0.25% ropivacaine will be injected below the fascia of the erector spinae muscle group.
Pre-operative Transversus Abdominus Plane blocks prior to DIEP surgery
Procedure/SurgeryOn the morning of surgery, the patients in the TAPs group will receive a bilateral ultrasound-guided Transversus Abdominus plane peripheral nerve block. During this intervention, 0.25% ropivacaine will be injected into the transversus abdominus plane above the transversus abdominus muscle.
Treatment groups
102 Participants
are divided into 2 treatment groupsGroup A: Group 1: Erector Spinae Plane blocksOther 1 intervention
Group B: Group 2: Transversus Abdominis Plane blocksOther 1 intervention
Trial outcomes
Primary outcomes
1
Numerical Rating Scale
Scale used to measure pain on scale from 0-10 (0 is 'no pain' and 10 is 'the worst pain imaginable')
Time frame
24 hours post injection2
Mean Morphine Equivalents
Amount of opioid pain medications administered and converted to morphine equivalents
Time frame
24 hours post injectionSecondary outcomes
1
Numerical Rating Scale
Scale used to measure pain on scale from 0-10 (0 is 'no pain' and 10 is 'the worst pain imaginable')
Time frame
12 hours post injection2
Michigan Body Map
Map used to show body location of worst site of primary pain
Time frame
24 hours post injection3
Mean Morphine Equivalents
Amount of opioid pain medications administered and converted to morphine equivalents
Time frame
48 hours post injection4
Numerical Rating Scale
Scale used to measure pain on scale from 0-10 (0 is 'no pain' and 10 is 'the worst pain imaginable')
Time frame
48 hours post injectionSponsors and contacts
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Source ClinicalTrials.gov