The Post Cesarean Section Analgesic Effect of Various Quadratus Lumborum Block Approaches

Cesarean Section Clinical Trial

Official title:

Postoperative Analgesic Effects of Various Quadratus Lumborum Block Approaches Following Cesarean Section.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06393192
• Other study ID #: Soh-Med-23-09-6PD
• Status: Completed
• Start date: October 1, 2023
• Est. completion date: April 15, 2024

Study information

• Verified date: April 2024
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

included patients were divided into 4 groups and each group received a mode of post cesarian section analgesia and pain was assessed by visual analogue scale at rest and movement.

1. st group epidural analgesia

2. nd group Quadratus lumborum type 2

3. rd group Quadratus lumborum type 3

4. th group Quadratus lumborum type (2+3)

Description:

Patients fulfilling the eligibility criteria were approached prior to delivery. The attending physician explained the nature of the study and all patients signed an informed consent then patients were divided in to four groups as follows (equal sample size in each group): the QLB type 2 (QL2 group), QLB type 3 (QL3 group), QLB type 2 +3 (QL2+3 group) and EA only group.

A 16-gauge intravenous cannula pathway was established in the non-dominant hand or arm in the operation unit. All parturient with standard monitoring including electrocardiogram, pulse arterial oxygen saturation, respiratory rate and non-invasive blood pressure (NIBP) was performed combined with spinal and epidural anesthesia before C-section in the left lateral position and peripheral nerve block at the end of surgery by an experienced doctor (A.M.A). The epidural needle was inserted into the lumbar epidural space at the level of L2-3 intervertebral space.

After finding the epidural space using loss of resistance to saline technique, the tip of a spinal needle passed through the epidural needle. To achieve a sensory block height to the level of the sixth thoracic dermatome, every parturient received intrathecal anesthesia of 0.75% bupivacaine (1.3-1.7 )mL. Then, the needle was withdrawn and then an epidural catheter was inserted through the epidural needle in case the failure of intrathecal anesthesia. All surgical treatments were performed successfully in the usual manner.

Immediately after surgery, all subjects were transferred to the post-anesthesia care unit (PACU) and administered pre-determined analgesia, All parturient were lift in the supine position, tilting 45 degrees to the opposed side in order to place the low-frequency convex probe properly and see the sonography clearly. Bilateral QLB was performed using the atraumatic needle (22-G, 120-mm needle for peripheral nerve blocks) advanced in-plane under the guidance of an ultrasound machine. The ultrasonogram of the abdominal wall was displayed clearly through probe moving or tilting. Pillows helped to relieve the tension along the abdominal wall of parturient. The whole procedure was performed strictly according to clinical protocol.

In this study, QL2 or QL3 were conducted through an anterolateral approach with the supine position as mentioned in (Sato et al, 2017). The ultrasound transducer was placed transversely on both flanks at the horizontal level of L2-3 and adjusted until the "Shamrock sign" formed of QL muscle, psoas major and erector spinae was visualized, with imaging depth set between 0 and 9.9 cm. Needles will be penetrated in an anterolateral to posteromedial direction. Local anesthetic will be injected posterior to QL muscle in QL2, while in QL3, it will be located between QL muscle and psoas major. QL2+3 block was conducted in the same plane with only one puncture on each side.

QL2 and QL3 groups received 0.2% ropivacaine at 30 mL at the sites mentioned above in each side for a total of 60 mL. For QL2+3 group, they recieved 0.2% ropivacaine 15 mL at each point of injection with the needle inserting only once in each side. The solution was injected after negative aspiration to exclude vascular puncture. As for the EA group, we used a single bolus of 6 mL saline solution containing 9 mg ropivacaine (0.15%) and 2 mg morphine via the epidural catheter as postoperative analgesia, and meanwhile, they received a procedure like QL2, but only saline was injected as placebo.

Epidural catheters were detached from all parturient after the procedure mentioned above. Parturient received a standard postoperative analgesic regime of regular oral paracetamol 1.0 g 6 hourly.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 15, 2024
• Est. primary completion date: March 28, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• a normal singleton pregnancy lasting at least 37 weeks, body weight (50-70) kg, as well as having an American Society of Anesthesiologists (ASA) physical status I or II

Exclusion Criteria:

• Individuals with a history of congenital coagulopathy, certain infections, or cognitive impairments that would prevent them from using the verbal rating pain score method or the patient-controlled analgesia (PCA) pump were not involved in the study

Related Conditions & MeSH terms

• Cesarean Section
• Epidural Analgesia
• Painless Labor

Intervention

Procedure:
• Epidural analgesia (EA) only group
The epidural needle will be inserted into the lumbar epidural space at the level of L2-3 intervertebral space.
• Quadratus lumborum block (QL2)
0.2% bupivacaine at a volume of thirty milliliters were administered at the specified sites on each side behind the QL muscle, resulting in a total of Sixty mL
• Quadratus lumborum block 3(QL3)
0.2% bupivacaine at a volume of thirty milliliters were administered at the specified sites on each side among the QL muscle and the psoas major, resulting in a total of Sixty mL
• Quadratus lumborum block 2+3 QL(2+3)
0.2 percent bupivacaine solution of fifteen milliliters were administered at each injection site, with the needle being inserted once on each side

Locations

Country	Name	City	State
Egypt	Sohag University hospital	Sohag
Egypt	Sohag University, Medical school	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total morphine consumption	Total morphine consumption at specified intervals following operation in addition to postoperative pain assessment by the visual analogue scale (VAS, 0-100 mm) at rest and movement	zero, four, six, twelve, twenty-four hours & forty-eight hours postoperatively
Secondary	The side effects of the different interventions	Nausea & vomiting as well as itching, weak legs, urine retention, infection & bleeding	four, six, twelve, twenty-four hours & forty-eight hours postoperatively