Effect of Bilateral Quadratus Lumborum Block for Pain Relief in Patients With Cesarean Section
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|ClinicalTrials.gov Identifier: NCT03199170|
Recruitment Status : Completed
First Posted : June 26, 2017
Last Update Posted : September 26, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Caesarean Section Spinal Anesthesia Quadratus Lumborum Block Analgesia||Drug: Intrathecal morphine Drug: Bilateral Quadratus Lumborum Block Drug: Intrathecal morphine with bilateral Quadratus Lumborum Block||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Bilateral Quadratus Lumborum Block for Pain Relief in Patients With Cesarean Section|
|Actual Study Start Date :||September 1, 2017|
|Actual Primary Completion Date :||January 1, 2019|
|Actual Study Completion Date :||August 1, 2019|
Sham Comparator: Intrathecal morphine
Intrathecal morphine 0.2 mg, 0.9%NSS each side
Drug: Intrathecal morphine
0.5% Hyperbaric bupivacaine 2 ml add morphine 0.2 mg for spinal anesthesia
Experimental: Intrathecal morphine with bilateral Quadratus Lumborum Block
Intrathecal morphine 0.2 mg, 0.25%Bupivacaine 25 ml each side
Drug: Intrathecal morphine with bilateral Quadratus Lumborum Block
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
Experimental: Bilateral Quadratus Lumborum Block
No intrathecal morphine, 0.25%Bupivacaine 25 ml each side
Drug: Bilateral Quadratus Lumborum Block
0.25% Bupivacaine 25 ml each side for quadratus lumborum block without spinal morphine
- 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
- Pain score [ Time Frame: 48 hours postoperatively ]Pain score at rest and on movement rating by numerical rating scale in 48-hr postoperative
- Requirement of rescue pain [ Time Frame: 48 hours postoperatively ]Requirement of pain control medication
- Adverse effect [ Time Frame: 48 hours postoperatively ]Incidence of side effects e.g. nausea and vomiting, itching and sedation
- Satisfaction score [ Time Frame: 48 hours postoperatively ]Satisfaction score rated from 0-100
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03199170
|Bangkok, Thailand, 10700|
|Principal Investigator:||Pawinee Pangthipampai, M.D.||Siriraj Hospital|