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

Not Applicable

Completed

• Conditions: Spinal Anesthesia; Analgesia; Caesarean Section; Quadratus Lumborum Block
• Interventions: Drug: Intrathecal morphine; Drug: Intrathecal morphine with bilateral Quadratus Lumborum Block; Drug: Bilateral Quadratus Lumborum Block

• Registration Number: NCT03199170
• Lead Sponsor: Mahidol University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-06-22
• Study First Submitted QC: 2017-06-22
• Study First Posted: 2017-06-26
• Study Start: 2017-09-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-08-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intrathecal morphine	Intrathecal morphine	Intrathecal morphine 0.2 mg, 0.9%NSS each side
Intrathecal morphine with bilateral Quadratus Lumborum Block	Intrathecal morphine with bilateral Quadratus Lumborum Block	Intrathecal morphine 0.2 mg, 0.25%Bupivacaine 25 ml each side
Bilateral Quadratus Lumborum Block	Bilateral Quadratus Lumborum Block	No intrathecal morphine, 0.25%Bupivacaine 25 ml each side

Primary Outcome Measures

Name	Time	Method
Time to first analgesic request (PCA morphine)	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 Outcome Measures

Name	Time	Method
Requirement of rescue pain	48 hours postoperatively	Requirement of pain control medication
Satisfaction score	48 hours postoperatively	Satisfaction score rated from 0-100
Pain score	48 hours postoperatively	Pain score at rest and on movement rating by numerical rating scale in 48-hr postoperative
Adverse effect	48 hours postoperatively	Incidence of side effects e.g. nausea and vomiting, itching and sedation

Trial Locations

Locations (1)

Siriraj hospital; 🇹🇭 Bangkok, Thailand