Decreased Neuraxial Morphine After Cesarean Delivery

Anesthesia Clinical Trial

Official title:

Decreased Neuraxial Morphine and Adjunctive Peripheral Nerve Blockade to Reduce Severity of Side Effects and Opioid Use After Cesarean Delivery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04279054
• Other study ID #: IRB00000196
• Status: Active, not recruiting
• Phase: Early Phase 1
• Start date: September 9, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare 50mcg to 150mcg morphine in epidural for the goal of decreasing side effects of medication with lower dose in patients who receive a QL block

Description:

Regional anesthesia has been associated with reduced opioid consumption after surgery. Cesarean delivery is one of the most commonly performed surgeries worldwide and women undergoing cesarean delivery are often young, opioid-naïve, and motivated to recover quickly in an effort to better care for their newborn. However, approximately 1 in 300 opioid naïve women become persistent prescription opioid users following cesarean delivery . Hence, it is important to optimize post-cesarean pain control while limiting exposure to opioids. Currently, standard therapy includes the use of neuraxial morphine (NM) in combination with a multi-modal regime in an effort to limit excessive opioid use after cesarean delivery. The current typical dose of NM that is given prior to cesarean delivery at the investigator's center is 150 mcg. Importantly, NM doses as low as 100 mcg have been shown to provide comparable analgesia while reducing side effects such as itching. The side-effect profile associated with NM includes up to 87% of patients experiencing pruritus and up to 70% experiencing urinary retention. Nausea and vomiting also lead to significant discomfort for a new mother trying to provide acute infant care.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 87
• Est. completion date: December 31, 2024
• Est. primary completion date: July 5, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All women presenting for scheduled cesarean delivery who desire a QL block

Exclusion Criteria:

• Women with pregnancies complicated by preeclampsia

• 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

Related Conditions & MeSH terms

• Anesthesia

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
United States	UAB Women and Infants Center	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

References & Publications (17)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Reg Anesth Pain Med. 2018;43:111. — View Citation

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. — View Citation

Committee Opinion No. 666: Optimizing Postpartum Care. Obstet Gynecol. 2016 Jun;127(6):e187-e192. doi: 10.1097/AOG.0000000000001487. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Quinlan JD, Murphy NJ. Cesarean delivery: counseling issues and complication management. Am Fam Physician. 2015 Feb 1;91(3):178-84. — View Citation

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. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Outcome of side effects of intervention: pruritus	Incidence of primary outcome surrogate marker by need for medication for pruritus based on verbal complaints from patient (Medication given: Yes or No)	One assessment during hospital stay - up to postoperative day 2 (2 days following cesarean delivery)
Primary	Outcome of side effects of intervention: nausea	Incidence of primary outcome surrogate marker by need for medication for nausea based on verbal complaints from patient (Medication given: Yes or No)	One assessment during hospital stay - up to postoperative day 2
Primary	Outcome of side effects of intervention: urinary retention	Incidence of primary outcome surrogate marker by need for removal of foley catheter as measure for urinary retention	One assessment during hospital stay - up to postoperative day 2 (2 days following cesarean delivery)
Secondary	Maternal secondary outcomes from intervention	Total amount of morphine use during hospital stay (cumulative morphine administered to control pain during hospital stay)	One assessment during hospital stay - up to postoperative day 2 (2 days following cesarean delivery)
Secondary	Maternal secondary outcomes from intervention	Incidence of daily pain scores (measured by pain score ratings: 1-10); 1: lowest pain score 10: maximum pain score	One measurement during entire hospital stay
Secondary	Neonatal secondary outcomes from intervention	Apgar scores	Within first hour of birth
Secondary	Neonatal secondary outcomes from intervention	Incidence of babies with signs of respiratory depression	Within first hour of birth