AzTrials
AzTrials

AnesthesiaEarly Phase 1NCT04279054

Decreased Neuraxial Morphine After Cesarean Delivery

A Early Phase 1 study testing Morphine Sulfate 150 mcg and Morphine Sulfate 50mcg in people with Anesthesia, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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 Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Anesthesia
What is being tested?
Morphine Sulfate 150 mcg and Morphine Sulfate 50mcg
Could I receive a placebo?
No, everyone receives an active treatment
How many people
87 participants
Where
1 siteUnited States
Study dates
9 Sep 2020to 5 Jul 2023
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UAB Women and Infants Center

    Birmingham, Alabama, 35233

Other trials in United States

About this study

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

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

Read the detailed 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

Conditions
Anesthesia
Being tested
Morphine Sulfate 150 mcg, Morphine Sulfate 50mcg
Keywords
cesarean delivery, epidural, Neuraxial block, anesthesia side effects

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Morphine Sulfate 150 mcgDrug

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

  • Morphine Sulfate 50mcgDrug

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

Study groups in NCT04279054
Study groupRoleWhat they receive
Group A: 150 mcg morphineActive comparatorPatients in this group will receive 150mcg of morphine in their neuraxial block
Receives: Drug: Morphine Sulfate 150 mcg
Group B: 50 mcg morphineExperimentalPatients in this group will receive 50mcg of morphine in their neuraxial block
Receives: Drug: Morphine Sulfate 50mcg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

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

  2. 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)

    Measured: One assessment during hospital stay - up to postoperative day 2

  3. 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

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

Secondary outcomes (4)

  1. Maternal secondary outcomes from intervention

    Total amount of morphine use during hospital stay (cumulative morphine administered to control pain during hospital stay)

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

  2. 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

    Measured: One measurement during entire hospital stay

  3. Neonatal secondary outcomes from intervention

    Apgar scores

    Measured: Within first hour of birth

  4. Neonatal secondary outcomes from intervention

    Incidence of babies with signs of respiratory depression

    Measured: Within first hour of birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Feb 2020
  2. Study start9 Sep 2020
  3. Primary completion5 Jul 2023
  4. Study completion5 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04279054
Sponsor's protocol ID
IRB00000196
Other IDs
UL1TR003096
Status last verified
Mar 2025
First submitted
13 Feb 2020
Last updated
30 Mar 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29758587

  • 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.

    PubMed 26996986

  • 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.

    PubMed 18502360

  • 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.

    PubMed 26225500

  • 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.

    PubMed 18165577

  • 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.

    PubMed 21498494

  • 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.

    PubMed 29296094

  • 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.

    PubMed 27717634

  • 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.

    PubMed 29406174

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

    PubMed 25822271

  • 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.

    PubMed 16735805

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

    PubMed 27214194

  • 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.

    PubMed 23811424

  • 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.

    PubMed 25786679

  • 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.

    PubMed 27755488

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Morphine Sulfate 150 mcg and Morphine Sulfate 50mcg in people with Anesthesia, run by University of Alabama at Birmingham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Outcome of side effects of intervention: pruritus (time frame: One assessment during hospital stay - up to postoperative day 2 (2 days following cesarean delivery)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04279054, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in