Study Results
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Basic Information
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COMPLETED
EARLY_PHASE1
87 participants
INTERVENTIONAL
2020-09-09
2023-07-05
Brief Summary
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Detailed Description
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Adjunctive Peripheral Nerve Blockade has recently been introduced to reduce postoperative pain and opioid use. Studies have assessed the usefulness of the transversus abdmoninis plane (TAP) block after cesarean delivery. Another ultrasound-guided injection of local anesthetic in the fascial plane (truncal block) that is available at UAB and within the standard of care for patients undergoing abdominal surgery is the quadratus lumborum (QL) block. Because of its more posterior and caudal location, it is more likely to anesthetize the nerve fibers associated with pain from cesarean delivery.
This study will compare the use of 50mcg to 150mcg morphine for the goal of decreasing side effects of medication with lower dose in all patients who receive a QL block
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group A: 150 mcg morphine
Patients in this group will receive 150mcg of morphine in their neuraxial block
Morphine Sulfate 150 mcg
Use of 150mcg of morphine sulfate for neuraxial block (dosing difference)
Group B: 50 mcg morphine
Patients in this group will receive 50mcg of morphine in their neuraxial block
Morphine Sulfate 50mcg
Use of 50mcg of morphine sulfate for neuraxial block (dosing difference)
Interventions
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Morphine Sulfate 150 mcg
Use of 150mcg of morphine sulfate for neuraxial block (dosing difference)
Morphine Sulfate 50mcg
Use of 50mcg of morphine sulfate for neuraxial block (dosing difference)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Women with pregnancies complicated by insulin-treated diabetes
* Women with pregnancies complicated by placental abnormalities
* Women with pregnancies complicated by a history of opioid use disorder
FEMALE
No
Sponsors
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University of Alabama at Birmingham
OTHER
Responsible Party
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Ayodeji Sanusi
Principal Investigator/ Assistant Professor Maternal Fetal Medicine
Principal Investigators
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Ayodeji Sanusi, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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UAB Women and Infants Center
Birmingham, Alabama, United States
Countries
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References
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Donauer K, Bomberg H, Wagenpfeil S, Volk T, Meissner W, Wolf A. Regional vs. General Anesthesia for Total Knee and Hip Replacement: An Analysis of Postoperative Pain Perception from the International PAIN OUT Registry. Pain Pract. 2018 Nov;18(8):1036-1047. doi: 10.1111/papr.12708. Epub 2018 Jun 25.
Bateman BT, Franklin JM, Bykov K, Avorn J, Shrank WH, Brennan TA, Landon JE, Rathmell JP, Huybrechts KF, Fischer MA, Choudhry NK. Persistent opioid use following cesarean delivery: patterns and predictors among opioid-naive women. Am J Obstet Gynecol. 2016 Sep;215(3):353.e1-353.e18. doi: 10.1016/j.ajog.2016.03.016. Epub 2016 Mar 17.
Girgin NK, Gurbet A, Turker G, Aksu H, Gulhan N. Intrathecal morphine in anesthesia for cesarean delivery: dose-response relationship for combinations of low-dose intrathecal morphine and spinal bupivacaine. J Clin Anesth. 2008 May;20(3):180-5. doi: 10.1016/j.jclinane.2007.07.010.
Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after caesarean section: A randomised controlled trial. Eur J Anaesthesiol. 2015 Nov;32(11):812-8. doi: 10.1097/EJA.0000000000000299.
McDonnell JG, Curley G, Carney J, Benton A, Costello J, Maharaj CH, Laffey JG. The analgesic efficacy of transversus abdominis plane block after cesarean delivery: a randomized controlled trial. Anesth Analg. 2008 Jan;106(1):186-91, table of contents. doi: 10.1213/01.ane.0000290294.64090.f3.
McMorrow RC, Ni Mhuircheartaigh RJ, Ahmed KA, Aslani A, Ng SC, Conrick-Martin I, Dowling JJ, Gaffney A, Loughrey JP, McCaul CL. Comparison of transversus abdominis plane block vs spinal morphine for pain relief after Caesarean section. Br J Anaesth. 2011 May;106(5):706-12. doi: 10.1093/bja/aer061.
Faiz SHR, Alebouyeh MR, Derakhshan P, Imani F, Rahimzadeh P, Ghaderi Ashtiani M. Comparison of ultrasound-guided posterior transversus abdominis plane block and lateral transversus abdominis plane block for postoperative pain management in patients undergoing cesarean section: a randomized double-blind clinical trial study. J Pain Res. 2017 Dec 19;11:5-9. doi: 10.2147/JPR.S146970. eCollection 2018.
Champaneria R, Shah L, Wilson MJ, Daniels JP. Clinical effectiveness of transversus abdominis plane (TAP) blocks for pain relief after caesarean section: a meta-analysis. Int J Obstet Anesth. 2016 Dec;28:45-60. doi: 10.1016/j.ijoa.2016.07.009. Epub 2016 Aug 5.
Ng SC, Habib AS, Sodha S, Carvalho B, Sultan P. High-dose versus low-dose local anaesthetic for transversus abdominis plane block post-Caesarean delivery analgesia: a meta-analysis. Br J Anaesth. 2018 Feb;120(2):252-263. doi: 10.1016/j.bja.2017.11.084. Epub 2017 Dec 5.
Quinlan JD, Murphy NJ. Cesarean delivery: counseling issues and complication management. Am Fam Physician. 2015 Feb 1;91(3):178-84.
Lavand'homme P. Postcesarean analgesia: effective strategies and association with chronic pain. Curr Opin Anaesthesiol. 2006 Jun;19(3):244-8. doi: 10.1097/01.aco.0000192815.22989.61.
Committee Opinion No. 666: Optimizing Postpartum Care. Obstet Gynecol. 2016 Jun;127(6):e187-e192. doi: 10.1097/AOG.0000000000001487.
Abdallah FW, Laffey JG, Halpern SH, Brull R. Duration of analgesic effectiveness after the posterior and lateral transversus abdominis plane block techniques for transverse lower abdominal incisions: a meta-analysis. Br J Anaesth. 2013 Nov;111(5):721-35. doi: 10.1093/bja/aet214. Epub 2013 Jun 27.
Telnes A, Skogvoll E, Lonnee H. Transversus abdominis plane block vs. wound infiltration in Caesarean section: a randomised controlled trial. Acta Anaesthesiol Scand. 2015 Apr;59(4):496-504. doi: 10.1111/aas.12498.
Blanco R, Ansari T, Riad W, Shetty N. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):757-762. doi: 10.1097/AAP.0000000000000495.
Hirabayashi M, Doi K, Imamachi N, Kishimoto T, Saito Y. Prophylactic Pentazocine Reduces the Incidence of Pruritus After Cesarean Delivery Under Spinal Anesthesia With Opioids: A Prospective Randomized Clinical Trial. Anesth Analg. 2017 Jun;124(6):1930-1934. doi: 10.1213/ANE.0000000000002060.
Aly M, Ibrahim A, Farrag W, Abdelsalam K, Mohamed H, Tawfik A. Pruritus after intrathecal morphine for cesarean delivery: incidence, severity and its relation to serum serotonin level. Int J Obstet Anesth. 2018 Aug;35:52-56. doi: 10.1016/j.ijoa.2018.02.004. Epub 2018 Feb 16.
Other Identifiers
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IRB00000196
Identifier Type: -
Identifier Source: org_study_id
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