Quadratus Lumborum in Cesarean Section Trial (QUALICS)

University of Sao Paulo General Hospital

Status: Completed

Conditions: Postoperative Analgesia

Treatments: Procedure: Quadratus Lumborum Block

Study type: Interventional

Funder types: Other

Identifiers

NCT03673280

CAAE 90600818.0.0000.0068

Details and patient eligibility

About

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.

Full 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.

Enrollment: 61 patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Minimum age of 18 years
• Minimum gestational age of 37 weeks with a single fetus
• Patients scheduled for elective cesarean section through a Pfannenstiel incision under spinal anesthesia
• American Society of Anesthesiology physical status (ASA) II
• Body mass index (BMI) under 40 kg/m²
• No use of opioids for the past 4 weeks
• No history of psychotropic drug use
• No contraindication for any of the medications involved in the study
• No previously known malformations of the fetus
• No previous history of chronic pain

Exclusion criteria

• Difficulty in understanding how to use the patient-controlled analgesia (PCA) device
• Study protocol violation
• Patient decision to withdraw participation

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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61 participants in 3 patient groups, including a placebo group

Classical spinal anesthesia

Placebo Comparator group

Description:

Patients allocated to this group will receive spinal anesthesia with bupivacaine 12.5mg, Fentanyl 20mcg and Morphine 80mcg + placebo quadratus lumborum block.

Treatment:

Procedure: Quadratus Lumborum Block

Spinal anaesthesia with block

Experimental group

Description:

Patients allocated to this group will receive spinal anesthesia with bupivacaine 12.5mg, Fentanyl 20mcg + quadratus lumborum block.

Treatment:

Procedure: Quadratus Lumborum Block

Classical anaesthesia plus block

Experimental group

Description:

Patients allocated to this group will receive spinal anesthesia with bupivacaine 12.5mg, Fentanyl 20mcg and Morphine 80mcg + quadratus lumborum block.

Treatment:

Procedure: Quadratus Lumborum Block