Methadone vs Morphine for Pain After Cesarean Delivery
Recruiting in Palo Alto (17 mi)
Overseen ByEmily E Sharpe, M.D.
Age: 18+
Sex: Female
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Mayo Clinic
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?The purpose of this study is to determine if there is a difference in opioid requirements at 0-48 hours after scheduled cesarean delivery in patients receiving 150 mcg intrathecal morphine compared to 0.2 mg/kg (maximum 20 mg) intravenous methadone.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you have a history of chronic pain, opioid use, or certain health conditions, you may not be eligible to participate.
What data supports the effectiveness of the drug Methadone for pain after cesarean delivery?
Research comparing oral methadone to intramuscular pethidine (another pain relief drug) suggests that methadone can be effective for managing pain after a cesarean section. This indicates that methadone may be a viable option for pain relief in this context.
12345Is methadone safe for pain relief after a cesarean delivery?
Research indicates that methadone is effective and generally safe for pain relief after a cesarean delivery, with few side effects reported. However, caution is advised with high doses due to potential heart-related risks, and more studies are needed to fully understand its safety compared to other opioids.
46789How does the drug methadone differ from morphine for pain relief after cesarean delivery?
Methadone, when used epidurally, is shown to be an effective and safe method for pain relief after cesarean delivery, with fewer side effects compared to morphine. It provides longer-lasting pain relief, which can be beneficial for managing postoperative pain.
46101112Eligibility Criteria
This trial is for English-speaking women over 18 years old scheduled for a cesarean delivery. It's not suitable for those with opioid intolerance, severe obesity (BMI >50), heart issues (QTc >440ms), high-risk health status (ASA IV, V), chronic pain or substance use disorders, liver/kidney failure, certain respiratory conditions, pre-eclampsia in current pregnancy, depression treated with multiple medications, or if general anesthesia becomes necessary.Inclusion Criteria
I am over 18 years old.
Exclusion Criteria
I cannot have spinal anesthesia due to health reasons.
My health is severely impaired, making me a high-risk patient for surgery.
I had surgery complications needing a switch to general anesthesia.
I have had liver or kidney failure in the past.
I have a history of breathing problems or need extra oxygen.
I have been diagnosed with pre-eclampsia during my current pregnancy.
I take more than one medication for depression.
Participant Groups
The study compares post-cesarean pain management between two drugs: intrathecal morphine at 150 mcg and intravenous methadone at 0.2 mg/kg (up to 20 mg). The goal is to see which leads to lower opioid needs within the first 48 hours after surgery.
2Treatment groups
Experimental Treatment
Active Control
Group I: Spinal Anesthesia with Intravenous MethadoneExperimental Treatment1 Intervention
Subjects will receive spinal anesthesia (intrathecal bupivacaine with fentanyl) with intravenous methadone
Group II: Spinal Anesthesia with Intrathecal MorphineActive Control1 Intervention
Subjects will receive spinal anesthesia (intrathecal bupivacaine with fentanyl) with intrathecal morphine
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Mayo Clinic in RochesterRochester, MN
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Who is running the clinical trial?
Mayo ClinicLead Sponsor
References
Patterns of Opioid Prescription and Use After Cesarean Delivery. [2022]To define the amount of opioid analgesics prescribed and consumed after discharge after cesarean delivery.
Multimodal Stepwise Approach to Reducing In-Hospital Opioid Use After Cesarean Delivery: A Quality Improvement Initiative. [2020]To evaluate the association of a standardized, structured approach to in-hospital postcesarean delivery pain management with maternal opioid use after cesarean delivery.
Intrapartum and postpartum analgesia for women maintained on methadone during pregnancy. [2013]To determine whether methadone maintenance alters intrapartum or postpartum pain or medication requirements.
Pain relief after cesarean section: Oral methadone vs. intramuscular pethidine. [2022]Appropriate pain management is needed during the post-partum hospitalization period for preventing cesarean section (CS) related complications. Protocols of post-partum pain management should be planned based on the facilities of each center or region. The aim of current study was to compare the analgesic efficacy of oral methadone and intra muscular (IM) pethidine which the latter was routinely used in our center in post cesarean pain treatment.
Opioid prescription-use after cesarean delivery: an observational cohort study. [2021]To evaluate current opioid prescription practices following a cesarean delivery.
Postoperative analgesia for Caesarean section using epidural methadone. [2019]A prospective randomised double blind study was carried out to compare the use of epidural methadone, morphine and bupivacaine for pain relief after Caesarean section. The results indicate that methadone is the most effective agent with few side effects. Subsequently this method was used routinely for postoperative analgesia in all patients undergoing Caesarean section. A retrospective study of 178 patients having this method of analgesia was carried out and indicated that epidural methadone is an effective and safe method of postoperative pain relief.
Buprenorphine Versus Methadone for Opioid Dependence in Pregnancy. [2018]To evaluate maternal and neonatal safety outcomes for methadone and buprenorphine in the obstetric population.
Efficacy and safety of intraoperative intravenous methadone during general anaesthesia for caesarean delivery: a retrospective case-control study. [2013]Most patients undergoing caesarean delivery with general anaesthesia require systemic opioid administration. Due to its rapid onset and long duration of action, intravenous methadone may make it suitable for analgesia after caesarean delivery. Intraoperative methadone combined with postoperative intravenous patient-controlled analgesia with fentanyl or morphine has recently been introduced in our unit.
Methadone for treatment of cancer pain. [2019]Methadone is a unique mu opioid agonist, which also has delta receptor affinity and properties of N-methyl-D-aspartate receptor antagonism and monoamine reuptake inhibition. It is mainly used in the setting of uncontrolled pain or dose-limiting toxicity. Caution is advised when switching to methadone, especially from high doses of previous opioid, due to its variable conversion ratio and the potential for delayed toxicity due to its long half-life. Increasing evidence of risk also exists for a prolonged QT interval and torsades de pointes with very large doses of methadone. Methadone is likely safer when used at lower doses as a first-line opioid, but its potential as such has not received enough formal evaluation. Randomized controlled trials are needed to assess the effectiveness and safety of methadone compared with other opioids and to further evaluate its role in the treatment of neuropathic pain.
Comparison of different doses of epidural morphine for pain relief following cesarean section. [2013]Although epidural opioid analgesia after cesarean section can provide excellent postoperative pain relief, serious complications may occur after epidural morphine. Therefore, we performed this study to compare the efficacy and side effects of three different doses of epidural morphine for analgesia following cesarean section. Ninety healthy pregnant women who underwent cesarean delivery were randomly assigned to receive either 2.5, 3 or 4 mg of epidural morphine for postoperative analgesia. Pain intensity at rest and on movement using a visual analogue scale (0-10) was regularly assessed for 48 hours, the time to first analgesic requirement, the total analgesic dose, patient satisfaction and side effects were recorded. Chi square and ANOVA tests were used for statistical analyses. We were unable to demonstrate any difference in pain relief, patient satisfaction, and side effects among the three groups. Epidural morphine provided sufficient pain relief for approximately 24 hours. About 27 per cent of the patients from each group were pain-free for up to 48 hours without further analgesics. Mild pruritus and nausea occurred in all three groups and there was no significant difference between them. No serious complications were observed. In conclusion low dose epidural morphine is effective in providing adequate analgesia following cesarean delivery.
A randomized controlled trial of spinal morphine with an enhanced recovery pathway and its effect on duration of analgesia after cesarean delivery. [2023]Intrathecal morphine is frequently administered after cesarean delivery to provide pain relief lasting up to 24 h. An enhanced recovery after cesarean pathways reduces the amount of postoperative opioids needed. The ideal dose of intrathecal morphine when combined with a pathway has not been determined.
Comparison of epidural methadone with epidural diamorphine for analgesia following caesarean section. [2019]Analgesia provided by either 5 mg diamorphine, or 5 mg methadone administered by the epidural route during elective caesarean section was compared in 40 women. The median time to further analgesia in the methadone group was 395 min, and 720 min in the diamorphine group, P = 0.0003. Linear analogue scores to assess pain were measured 2-hourly for 12 h, then again at 24 h postoperatively. Pain scores were significantly lower in the diamorphine group at 8 and 10 h. The median cumulative i.m. morphine dose administered during the first 24 h was 20 mg in the methadone group and 0 mg in the diamorphine group (P = 0.0005). Nausea and pruritus were common side effects in both groups. Continuous pulse oximetry data were available for 12 h post-operatively in 15 patients receiving methadone, and in 17 patients receiving diamorphine. One or more episodes of significant desaturation (