Quadratus Lumborum in Cesarean Section Trial

Postoperative Analgesia Clinical Trial

— QUALICS  

Official title:

Comparison Between Intrathecal Morphine and Quadratus Lumborum Block for Postpartum Analgesia of Elective Cesareans.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03673280
• Other study ID #: CAAE 90600818.0.0000.0068
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 18, 2018
• Est. completion date: June 1, 2019

Study information

• Verified date: September 2018
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Postoperative pain of a caesarean section may be of high intensity, especially in the first 48 hours after the procedure, which affects the mother / newborn relationship, in addition to having the potential to progress to chronic pain. The use of intrathecal morphine is effective in post-caesarean analgesia, but carries unwanted side effects, including nausea, vomiting, urinary retention and pruritus. Therefore, alternative techniques of analgesia become necessary.

First described in 2007, ultrasound-guided quadratus lumborum (QL) block has gained prominence due to its analgesic superiority to the TAP block. Besides providing somatic analgesia, it also seems to inhibit visceral pain because the local anesthetic reaches the paravertebral space, this was observed by magnetic resonance imaging with contrast medium injected at the QL block site.

Description:

C-section is one of the most performed surgical procedures in the world, and presents great potential for postoperative pain, especially in the first 48 hours. Pain in this period represents a risk for evolution to chronic pain, but its incidence is still very divergent when comparing the studies, ranging from 1% to 18%.

The use of intrathecal morphine (MIT) is consecrated as a first-choice method of analgesia for post-partum cesarean delivery; however, its use carries relevant side effects for the puerpera, such as pruritus, nausea, urinary retention and , more rarely, respiratory depression. In the last decade, new adjunctive forms of postoperative analgesia have become more popular, such as regional blockades, highlighting the blockage of the Transversus Abdominis plane block (TAP) and the Quadratus Lumborum block (QL), taking as benefits the prolonged analgesia they provide and the low incidence of side effects. Another factor that contributes to the popularization of regional blocks is the increasing availability of ultrasound devices in the anesthetic-surgical environment. Studies evaluating TAP block after cesarean section performed under spinal anesthesia have shown a discrete benefit in decreasing postoperative opioid consumption in addition to improving pain scores. When comparing MIT with TAP block, the superiority of MIT is due to visceral analgesia while TAP block is restricted to abdominal wall analgesia.

Ultrasound-guided Lumbar Quadrant blockade has gained prominence due to its analgesic superiority over the TAP block, because in addition to providing somatic analgesia it also seems to inhibit visceral pain since the local anesthetic reaches the paravertebral space, this was observed by magnetic resonance imaging with contrast injected at the site of the QL block.

Reviewing the literature in 2018, there are no clinical trials comparing the use of intrathecal morphine with the quadratus lumborum block.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 75
• Est. completion date: June 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Minimum age of 18 years

• Minimum gestational age of 37 weeks with a single fetus

• Patients scheduled for elective cesarean section

Exclusion Criteria:

• Clinical contraindication to spinal anesthesia

• Morbid obesity (BMI> 35kg / m²)

• Drug addiction

• Chronic use of opioids or benzodiazepines

• Inability to understand or handle the PCA pump

• Allergy to any medication included in the protocol

Related Conditions & MeSH terms

• Postoperative Analgesia

Intervention

Procedure:
• Quadratus Lumborum Block
Instead of using morphine in the classical spinal anaesthesia we will be performing in the experimental group the Quadratus Lumborum Block

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morphine consumption	Evaluate pain in the postoperative period with to the consumption of morphine through PCA (patient controlled analgesia) pump.	24 hours
Primary	Pain intensity	Verbal numeric scale	24 hours
Secondary	Nausea and Vomiting	Evaluate the incidence of nausea and vomiting between the groups through referred nausea scale from none, mild, moderate or severe.	24 hours
Secondary	Pruritus	Evaluate the incidence of pruritus between the groups through pruritus referred scale from none, mild, moderate or severe.	24 hours
Secondary	Chronic pain	Evaluate the incidence of chronic pain between the groups through patient referred presence or absence of pain.	3 months
Secondary	Urinary retention	Evaluate the incidence of urinary retention between the groups through patient referred presence or absence of urinary retention.	24 hours