Intrathecal Hydromorphone vs Intrathecal Morphine to Treat Post Cesarean Pain in Patients With Opioid Use Disorder Taking Buprenorphine

NCT06784180 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 23-3302
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center, double-blind, randomized trial to compare the effects of intrathecal hydromorphone versus intrathecal morphine to treat post cesarean pain in patients with OUD taking buprenorphine. Inclusion criteria include American Society of Anesthesiologists (ASA) Physical Status II or III presenting for cesarean delivery to be done under spinal anesthesia, who have a diagnosis of OUD and are taking buprenorphine. Exclusion criteria include contraindication to spinal anesthesia, allergy/intolerance to acetaminophen or ibuprofen and laboring patients who have an epidural that will be used for anesthesia for cesarean delivery. Potential subjects will be approached about participating in the study at either their preop anesthesia visit or on the day of surgery after surgical and anesthesia consent has been obtained. Enrolled patients will be randomly allocated to receive either 200 mcg of intrathecal morphine or 100 mcg of intrathecal hydromorphone (study opioid medication). Intraoperatively, with the patient in a sitting position a spinal block will be performed with administration of 0.75% bupivacaine in 8.25% dextrose, 15 mcg fentanyl and the study opioid medication. Supplemental intraoperative analgesia/anxiolysis will be administered at the discretion of the anesthesia care team. Ultrasound-guided transversus abdominis plane blocks will be performed bilaterally at the end of the procedure with 10mL liposomal bupivacaine mixed with 10mL 0.25% bupivacaine injected on each side. Post-cesarean multimodal pain regimen will include scheduled acetaminophen 650mg every 6 hours and scheduled ibuprofen 600mg every 6 hours. Oxycodone will be ordered for breakthrough pain, starting at 5mg every 6 hours as needed. Escalation of as needed pain medication will be at the discretion of the anesthesia team. The patient will be followed for the following 36 hours postoperatively. The primary outcome is the patient's pain score with movement at 12 hours. Secondary outcomes include pain scores at rest and with movement at 6 and 24 hours, satisfaction with anesthesia, time to first opioid use, total opioid consumption in 24 and 36 hours, subjective rating of nausea and pruritis over first 24 hours , treatment for nausea or pruritis in 24 and 36 hours, Obstetric Quality of Recovery 10 (ObsQoR10) score, and Global Health Numeric Rating Scale (NRS) score.

Conditions

Opioid Use Disorder

Keywords

Morphine; Hydromorphone; Intrathecal; Suboxone; Opioid use disorder; Buprenorphine

Outcome Measures

Primary Outcomes (1)

• Pain score with movement

  Using the pain rating scale, patient will score pain with movement (1-10, 10 being worst pain) at 12 hours postoperatively

  12 hours postoperatively

Secondary Outcomes (10)

• Pain scores at rest

  6 and 24 hours postoperatively

• Pain with movement

  6 and 24 hours postoperatively

• Satisfaction with anesthesia

  Within 24 hours postoperatively

• Time to first opioid use

  Within 72 hours postoperatively

• Total opioid consumption

  24 and 36 hours postoperatively

Study Arms (2)

Intrathecal Morphine

ACTIVE COMPARATOR

Participants in this arm will receive intrathecal 200 mcg of preservative free morphine (0.4mL) with administration of 0.75% bupivacaine in 8.25% dextrose (dose determined by patient weight, height, gestational age) and 15 mcg fentanyl

Drug: Morphine; Drug: Bupivacaine; Drug: Fentanyl

Intrathecal Hydromorphone

EXPERIMENTAL

Participants in this arm will receive intrathecal 100 mcg of preservative free hydromorphone (0.1mL) with 0.3mL of saline added for a total volume of 0.4mL with administration of 0.75% bupivacaine in 8.25% dextrose (dose determined by patient weight, height, gestational age) and 15 mcg fentanyl

Drug: Bupivacaine; Drug: Fentanyl; Drug: Hydromorphone

Interventions

Morphine DRUG

200 mcg intrathecal morphine

Also known as: Duramorph

Intrathecal Morphine

Bupivacaine DRUG

Intrathecal 0.75% bupivacine in 8.25% dextrose (Dose determined by weight, height, gestational age)

Also known as: Marcaine, Sensoricaine, Posimir

Intrathecal Hydromorphone; Intrathecal Morphine

Fentanyl DRUG

15 mcg intrathecal fentanyl

Also known as: Duragesic, Subsys

Intrathecal Hydromorphone; Intrathecal Morphine

Hydromorphone DRUG

100 mcg intrathecal hydromorphone

Also known as: Dilaudid, Exalgo

Intrathecal Hydromorphone

Eligibility Criteria

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

You may qualify if:

• American Society of Anesthesiologists (ASA) Physical Status II or III presenting for cesarean delivery to be done under spinal anesthesia,
• have a diagnosis of OUD
• taking buprenorphine

You may not qualify if:

• Contraindication to spinal anesthesia,
• allergy/intolerance to acetaminophen or ibuprofen
• laboring patients who have an epidural that will be used for anesthesia for cesarean delivery

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (20)

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MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Morphine; Bupivacaine; Fentanyl; Hydromorphone

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

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; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Amy Penwarden, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a single center, double-blind, randomized trial. The randomization process will occur through the use of a computer generated randomization scheme with allocation concealment in numbered opaque envelopes carried out by a blinded observer. Following randomization, opioid medications will be prepared by an anesthesia provider who is not involved in the clinical care of the patient. The opioid medications will be prepared so that the volume will be the same for both medications to ensure adequate blinding. Opioid medications will be either 200 mcg of preservative free morphine (0.4mL) or 100mcg of preservative free hydromorphone (0.1 mL) with 0.3 mL of saline added for a total volume of 0.4mL. The opioid medication will be labeled "intrathecal opioid" and given to the anesthesia provider that will be taking care of the patient. The anesthesia provider collecting the postoperative data will also be blinded to which intrathecal opioid medication the patient received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Enrolled patients will be randomly allocated to receive either 200 mcg of intrathecal morphine or 100 mcg of intrathecal hydromorphone.

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 20, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): January 1, 2029
• Last Updated: March 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Time Frame: beginning 9 and continuing for 36 months following publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.

Locations

US (1)