Decreased Neuraxial Morphine After Cesarean Delivery

NCT04279054 | Completed Early Phase 1 DMC FDA Drug

• 2 other identifiers: IRB00000196UL1TR003096
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Anesthesia

Keywords

cesarean delivery; epidural; Neuraxial block; anesthesia side effects

Outcome Measures

Primary Outcomes (3)

• 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)

• 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

• 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 Outcomes (4)

• Maternal secondary outcomes from intervention

  One assessment during hospital stay - up to postoperative day 2 (2 days following cesarean delivery)

• Maternal secondary outcomes from intervention

  One measurement during entire hospital stay

• Neonatal secondary outcomes from intervention

  Within first hour of birth

• Neonatal secondary outcomes from intervention

  Within first hour of birth

Study Arms (2)

Group A: 150 mcg morphine

ACTIVE COMPARATOR

Patients in this group will receive 150mcg of morphine in their neuraxial block

Drug: Morphine Sulfate 150 mcg

Group B: 50 mcg morphine

EXPERIMENTAL

Patients in this group will receive 50mcg of morphine in their neuraxial block

Drug: Morphine Sulfate 50mcg

Interventions

Morphine Sulfate 150 mcg DRUG

Use of 150mcg of morphine sulfate for neuraxial block (dosing difference)

Group A: 150 mcg morphine

Morphine Sulfate 50mcg DRUG

Use of 50mcg of morphine sulfate for neuraxial block (dosing difference)

Group B: 50 mcg morphine

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Women and Infants Center

Birmingham, Alabama, 35233, United States

Location

Related Publications (17)

• 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.

  PMID: 29758587 BACKGROUND

• 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.

  PMID: 26996986 BACKGROUND

• 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.

  PMID: 18502360 BACKGROUND

• 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.

  PMID: 26225500 BACKGROUND

• 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.

  PMID: 18165577 BACKGROUND

• 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.

  PMID: 21498494 BACKGROUND

• 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.

  PMID: 29296094 BACKGROUND

• 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.

  PMID: 27717634 BACKGROUND

• 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.

  PMID: 29406174 BACKGROUND

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

  PMID: 25822271 BACKGROUND

• 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.

  PMID: 16735805 BACKGROUND

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

  PMID: 27214194 BACKGROUND

• 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.

  PMID: 23811424 BACKGROUND

• 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.

  PMID: 25786679 BACKGROUND

• 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.

  PMID: 27755488 BACKGROUND

• 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.

  PMID: 28448397 BACKGROUND

• 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.

  PMID: 29544720 BACKGROUND

MeSH Terms

Interventions

Morphine

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Ayodeji Sanusi, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator/ Assistant Professor Maternal Fetal Medicine

Study Record Dates

• First Submitted: February 13, 2020
• First Posted: February 20, 2020
• Study Start: September 9, 2020
• Primary Completion: July 5, 2023
• Study Completion: July 5, 2023
• Last Updated: March 30, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)