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Completed

NCT Number: NCT03199170

Effect of Bilateral Quadratus Lumborum Block for Pain Relief in Patients With Cesarean Section

Cesarean section commonly induces moderate to severe pain for 48 hours. These patients have additional compelling reasons to provide adequate pain relief as early mobilization is a key factor to prevent the risk of thromboembolic event which is increased during pregnancy. Beside these, patients need to be pain free to takecare for their newborn and breastfeed them. Poorly controlled pain after cesarean section also increases risk of chronic pain and postpartum depression.

Intrathecal morphine is considered the "gold standard" for postoperative pain relief after cesarean delivery. The duration of analgesic effect of morphine extend to 12-24 hours. Its widespread use is due to its favorable pharmacokinetic profile, ease of administration and low cost. Although intrathecal morphine is highly effective, its use is associated with undesirable adverse effect particularly nausea, vomiting and pruritus which reduce overall patients' satisfaction. More serious complication is the risk of delayed maternal respiratory depression.

The Quadratus Lumborum block was first described in 2007 which demonstrates a spread to the paravertebral space, thus leads to a more extensive block to T5-L1 nerve branches and a long lasting block with the potential to provide visceral pain relief. Therefore, this block has an evolving role in postoperative analgesia for many lower abdominal surgeries. As the safety is concerned, there has been one report of a patient with unilateral hip flexion and knee extension weakness leading to unplanned overnight admission following lateral quadratus lumborum block after laparoscopic gynaecological operation.

If the result favors effective, it will have the advantage of a combination with intrathecal opioid to prolong the pain free period after cesarean section which has about 4,000 cases per year.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All singleton pregnant women with gestation of at least 37 weeks scheduled for elective cesarean section with American Society of Anesthesiologists (ASA) physical status 1 or 2

Exclusion criteria

  • refuse to receive spinal block
  • allergy to drugs used in research: morphine, local anesthetic drug and paracetamol
  • abnormal coagulopathy: congenital coagulopathy or who used anticoagulants
  • platelet dysfunction or thrombocytopenia
  • distorted anatomical structures of lumbar spines
  • systemic infection or local infection at both flank areas which are the punctures sites for quadratus lumborum block
  • unable to comprehend or use the verbal rating pain scoring system or patient-controlled analgesia

Treatment and study plan

Intrathecal morphine

Drug

0.5% Hyperbaric bupivacaine 2 ml add morphine 0.2 mg for spinal anesthesia

Bilateral Quadratus Lumborum Block

Drug

0.25% Bupivacaine 25 ml each side for quadratus lumborum block without spinal morphine

Intrathecal morphine with bilateral Quadratus Lumborum Block

Drug

0.5% Hyperbaric bupivacaine 2 ml add morphine 0.2 mg for spinal anesthesia and 0.25% Bupivacaine 25 ml each side for quadratus lumborum block

Primary outcomes

  1. Time to first analgesic request (PCA morphine)

    Time frame: 48 hours postoperatively

    Whether bilateral quadratus lumborum block can increase pain free period of patients undergo cesarean section under spinal block with intrathecal morphine or not

Secondary outcomes

  1. Pain score

    Time frame: 48 hours postoperatively

    Pain score at rest and on movement rating by numerical rating scale in 48-hr postoperative

  2. Requirement of rescue pain

    Time frame: 48 hours postoperatively

    Requirement of pain control medication

  3. Adverse effect

    Time frame: 48 hours postoperatively

    Incidence of side effects e.g. nausea and vomiting, itching and sedation

  4. Satisfaction score

    Time frame: 48 hours postoperatively

    Satisfaction score rated from 0-100

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 26, 2017
Registry last updated
Sep 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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