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Postoperative Analgesia After Cesarean DeliveryPhase 4NCT07807592

Ultrasound-Guided Posterior Quadratus Lumborum Block With Bupivacaine and Dexmedetomidine Versus Intrathecal Morphine for Postoperative Analgesia After Cesarean Delivery

A Phase 4 study testing Intrathecal Morphine and Ultrasound-Guided Posterior Quadratus Lumborum Block in people with Postoperative Analgesia After Cesarean Delivery, run by Assiut University.

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Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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Trial summary

Cesarean delivery (CD) is one of the most commonly performed surgical procedures worldwide, with millions of women undergoing the procedure annually (1). Despite advances in surgical techniques and perioperative care, postoperative pain management remains a significant clinical challenge (2). Read more about this study

Who is it for?
Ages 18 to 45 years, women only
What is being tested?
Intrathecal Morphine and Ultrasound-Guided Posterior Quadratus Lumborum Block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
No sites listed yet
Study dates
Oct 2026to Dec 2027
Phase
Phase 4

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 18 to 45 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Age ≥ 18 years • Singleton pregnancy • Term pregnancy (≥ 37 weeks gestation) • Scheduled for elective cesarean delivery under spinal anesthesia • American Society of Anesthesiologists (ASA) physical status II or III • Ability to provide written informed consent

Who cannot join

  • Contraindication to spinal anesthesia or regional nerve blockade • Known hypersensitivity to any study medication (bupivacaine, dexmedetomidine, morphine) • Significant cardiovascular, pulmonary, hepatic, or renal disease • Preeclampsia or eclampsia • Coagulopathy or bleeding diathesis • Infection at the injection site • Chronic pain conditions • Current opioid use or substance abuse • History of psychiatric illness that may interfere with pain assessment • Emergency cesarean delivery

About this study

Cesarean delivery (CD) is one of the most commonly performed surgical procedures worldwide, with millions of women undergoing the procedure annually (1). Despite advances in surgical techniques and perioperative care, postoperative pain management remains a significant clinical challenge (2). Moderate to severe postoperative pain is commonly reported following CD, which can seriously impair daily activities, hinder maternal-infant bonding, delay recovery, and increase the risk of negative psychological outcomes, including postpartum depression and chronic pain syndromes. Effective postoperative analgesia is crucial not only for maternal comfort but also for optimizing recovery outcomes. Adequate pain control facilitates early mobilization, reduces hospital length of stay, promotes breastfeeding initiation, and strengthens the maternal-infant relationship Consequently, clinicians continuously refine postoperative analgesic protocols to enhance both effectiveness and safety while minimizing adverse effects that could compromise maternal and neonatal well-being. The Challenge of Post-Cesarean Analgesia Intrathecal morphine (ITM) has long been considered the "gold standard" for postoperative analgesia following cesarean delivery due to its excellent analgesic efficacy and prolonged duration of action (3). Administered as a single injection during spinal anesthesia, ITM provides effective pain relief for 12-24 hours postoperatively, making it a cornerstone of enhanced recovery after cesarean (ERAC) protocols. However, ITM is associated with a significant side-effect profile that limits its clinical utility. Higher doses, while offering superior pain control, substantially increase the risk of adverse effects including pruritus, postoperative nausea and vomiting (PONV), urinary retention, and potentially life-threatening respiratory depression. Studies have demonstrated that pruritus occurs in up to 91% of patients receiving 200 mcg of ITM, while respiratory depression risk increases significantly with doses exceeding 0.3 mg (6). Although dose reduction can mitigate these effects, the optimal dose that balances analgesia with an acceptable side-effect profile remains controversial. Some evidence suggests that doses as low as 0.025-0.075 mg may be sufficient when combined with multimodal analgesia (5,6). ltrasound-guided regional nerve blocks have emerged as valuable components of multimodal analgesia, offering the potential for effective pain relief while reducing systemic opioid exposure. Among these techniques, the quadratus lumborum block (QLB) has gained significant attention for abdominal surgeries, including cesarean delivery. The QLB targets the fascial planes surrounding the quadratus lumborum muscle. Unlike the transversus abdominis plane (TAP) block, which primarily provides somatic analgesia of the anterolateral abdominal wall, the QLB offers potential advantages including more extensive sensory blockade (T6-L3) and the ability to address both somatic and visceral pain components through spread of local anesthetic to the paravertebral space (4,7) between groups. Evidence suggests that bilateral QLB provides more effective postoperative pain relief than TAP blocks for cesarean delivery, with better visceral pain control and greater opioid-sparing effects. The addition of dexmedetomidine as an adjuvant to local anesthetics in QLB has shown promising results. Dexmedetomidine, a selective alpha-2 adrenergic agonist, possesses analgesic and sedative properties without respiratory depression. Studies have demonstrated that perineural dexmedetomidine prolongs the duration of local anesthetic action, likely through localized vasoconstriction and inhibition of nerve fiber action potentials. Clinical trials have found that adding dexmedetomidine to bupivacaine in QLB significantly prolongs the time to first rescue analgesia request Study Aims and Hypotheses Primary Aim: To compare the analgesic efficacy of ultrasound-guided bilateral QLB with bupivacaine and dexmedetomidine versus intrathecal morphine for postoperative analgesia following elective cesarean delivery.

Being tested
Intrathecal Morphine, Ultrasound-Guided Posterior Quadratus Lumborum Block

What participants receive

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

  • Intrathecal MorphineDrug

    Intrathecal morphine (100 μg) administered with spinal anesthesia

  • Ultrasound-Guided Posterior Quadratus Lumborum BlockProcedure or surgery

    QLB will be performed. Under ultrasound guidance (low-frequency curvilinear probe), the quadratus lumborum muscle will be identified posterior to the transversalis fascia. A 22-gauge 80-100 mm needle will be inserted using an in-plane approach, and 25 mL of 0.25% bupivacaine with dexmedetomidine 0.5 μg/kg will be injected on each side after negative aspiration. The block will be performed bilaterally

Study groups in NCT07807592
Study groupRoleWhat they receive
Group ITMActive comparatorIntrathecal morphine (100 μg) administered with spinal anesthesia
Receives: Drug: Intrathecal Morphine
Group QLB:Active comparatorBilateral ultrasound-guided QLB with 0.25% bupivacaine (25 mL per side) plus (0.5 μg/kg) dexmedetomidine.
Receives: Procedure: Ultrasound-Guided Posterior Quadratus Lumborum Block

What is being measured

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

  1. Cumulative intravenous morphine consumption

    Cumulative intravenous morphine consumption at 24 hours postoperatively

    Measured: 24 hours

Timeline

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

  1. First posted8 Sep 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionOct 2027 (estimated)
  4. Study completionDec 2027 (estimated)

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
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07807592
Sponsor's protocol ID
PQL VS ITM
Status last verified
Sep 2026
First submitted
2 Sep 2026
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

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