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The purpose of this two-arm clinical study is to compare two nerve block techniques, the transversus abdominis plane (TAP) block and the quadratus lumborum (QL) block, in terms of how well they manage pain in the immediate postoperative period in patients undergoing deep inferior epigastric perforator flap breast reconstruction.
This study is a randomized trial with two parallel intervention arms comparing TAP and QL blocks for post-operative analgesia in patients undergoing deep inferior epigastric perforator (DIEP) flap breast reconstruction. Participants scheduled to undergo DIEP flap breast reconstruction will be prospectively recruited and randomly allocated to receive either a surgeon-placed TAP block intraoperatively or an anesthesiologist-placed, ultrasound-guided QL block preoperatively. The overall objective of this study is to provide evidence of a best-practice procedure for managing pain post-operatively.
Aim 1: To compare postoperative pain scores and total opioid consumption (in morphine milligram equivalents) in the first 48 hours postoperatively between the two study groups.
Hypothesis 1: Receipt of the QL block is associated with relatively lower postoperative pain scores and reduced total opioid consumption.
Aim 2: To describe any changes in operation duration, time spent in the PACU, length of stay, time to ambulation, and costs that may be associated with using the more efficacious nerve block (as determined by results related to the primary objective).
Hypothesis 2: The QL block will be associated with shorter time to ambulation, time spent in the PACU, and length of stay. Because of requirements for the QL block to be administered preoperatively solely under ultrasound guidance by an anesthesiologist, receipt of the QL block is associated with increased operation time and total procedural costs compared to receipt of the TAP block.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAP block | Active Comparator | Participants will receive a transversus abdominis plane (TAP) block intraoperatively, administered by the operating plastic surgeon. The drug components of the TAP block are 20 ml liposomal bupivacaine (Exparel) mixed with 20 ml 0.5% bupivacaine. |
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| QL block | Experimental | Participants will receive a quadratus lumborum (QL) block preoperatively, administered by the anesthesiologist under ultrasound guidance. The drug components of the QL block are 10 mg dexamethasone, 80 mg methylprednisolone acetate, plus either 0.25% or 0.5% bupivacaine at the dose of 0.25 mg/kg bupivacaine. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgeon-placed transversus abdominis plane block | Procedure | Participants will receive a transversus abdominis plane (TAP) block intraoperatively, administered by the operating plastic surgeon. The drug components of the TAP block are 20 ml liposomal bupivacaine (Exparel) mixed with 20 ml 0.5% bupivacaine. |
| Measure | Description | Time Frame |
|---|---|---|
| Participant self-reported pain score, as measured by the Visual Analogue Scale at postoperative hours 0, 2, 4, 6, 12, 24, 36, 48 | Participants will be asked to self-report their pain using the Visual Analogue Scale (VAS) at postoperative hours 0, 2, 4, 6, 12, 24, 36, and 48. The minimum sore on the VAS is 0 (no pain) and the maximum score is 10 (worst pain). | Postoperative hour 0 to 48 |
| Opioid consumption during the first 48 postoperative hours | Participants' opioid consumption (in morphine milligram equivalents) during the first 48 postoperative hours will be recorded. (or until pt is discharged?) | Postoperative hour 0 to 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Operation duration | Operation duration is measured as the time from first incision to final closure. (?) | Intraoperative period |
| Time spent in the post-anesthesia care unit | Time spent in the post-anesthesia care unit (PACU) is measured as the time out of the operating room to completion of PACU care. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Haripriya Ayyala, MD | Yale University | Principal Investigator |
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By nature of the nerve block techniques, the patient, operating surgeon, and anesthesiologist will be aware of the assignments of individual participants. The statistician who will analyze the data will be blinded to the assignments.
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| Ultrasound-guided quadratus lumborum block | Procedure | Participants will receive a quadratus lumborum (QL) block preoperatively, administered by the anesthesiologist under ultrasound guidance. The drug components of the QL block are 10 mg dexamethasone, 80 mg methylprednisolone acetate, plus either 0.25% or 0.5% bupivacaine at the dose of 0.25 mg/kg bupivacaine. |
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| Postoperative - interval immediately following surgery |
| Length of hospital stay | Length of stay is measured as the time from when the patient leaves the operating room to patient discharge. | Postoperative - approximately 48 hours |
| Time to ambulation | Time to ambulation is defined as the time from when the patient leaves the operating room to first ambulation (which is?). | Postoperative hour 0 to 48 |
| Costs associated with each intervention | We will consider personnel, medication, operation time, length of stay, and other intervention-specific costs to calculate total costs associated with each nerve block intervention. | Participant check-in to discharge, approximately 1 week |