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

NCT ID: NCT06393192

Last Updated: 2024-05-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-01
• Study Completion Date: 2024-04-15

Brief 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)

Detailed 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 Then, the needle was withdrawn and then an epidural catheter was inserted through the epidural needle in case the failure of intrathecal anesthesia.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.

Conditions

Painless Labor; Epidural Analgesia; Cesarean Section

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Epidural analgesia (EA) only group

In this group 20 patients fulfilling the eligibility criteria, the epidural needle was inserted at the level of the intervertebral gap that separates the 2nd & 3rd spinal bones.

Upon locating the epidural space through the utilization of the loss of resistance to saline approach, the tip of a spinal needle was inserted through the epidural needle. In order to reach a specific level of sensory block up to the sixth thoracic dermatome, each pregnant woman was administered intrathecal anesthetic consisting of 0.75 percent bupivacaine in a volume of 1.3-1.7 milliliter.

Subsequently, we removed the needle & proceeded to place an epidural catheter through the epidural needle as a precautionary measure in the event of intrathecal anesthetic failure. The EA group received a single dosage of six milliliters of saline solution containing nine milligrams of bupivacaine (0.15%) & 2 mg of morphine via the epidural catheter for postoperative pain management.

Epidural analgesia (EA) only group

Intervention Type: PROCEDURE

The epidural needle will be inserted into the lumbar epidural space at the level of L2-3 intervertebral space.

Quadratus Lumborum 2 (QL2) group

In this group 20 patients fulfilling the eligibility criteria, the ultrasound transducer was positioned horizontally at the level of L2-3 on both sides of the body. It was adjusted until the "Shamrock sign" created by the QL muscle, psoas major, and erector spinae was visible. The imaging depth was set among 0 as well as 9.9 cm. Needles were inserted from the front-lateral to back-medial direction. An injection of local anesthetic was administered behind the QL muscle.0.2% bupivacaine were administered at a volume of thirty milliliters at the specified sites on each side, resulting in a total of Sixty mL

Quadratus lumborum block (QL2)

Intervention Type: PROCEDURE

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 3 (QL3) group

In this group 20 patients fulfilling the eligibility criteria, the ultrasound transducer was positioned horizontally at the level of L2-3 on both sides of the body. It was adjusted until the "Shamrock sign" created by the QL muscle, psoas major, and erector spinae was visible. The imaging depth was set among 0 as well as 9.9 cm. Needles were inserted from the front-lateral to back-medial direction. An injection of local anesthetic was administered among the QL and the psoas major muscles.0.2% bupivacaine were administered at a volume of thirty milliliters at the specified sites on each side, resulting in a total of Sixty mL

Quadratus lumborum block 3(QL3)

Intervention Type: PROCEDURE

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 2+3 (QL2+3) group

In this group 20 patients fulfilling the eligibility criteria, the QL2+3 block can be performed in a single plane with only one puncture on each side. 0.2 percent bupivacaine solution of fifteen milliliters were administered at each injection site, with the needle being inserted once on each side

Quadratus lumborum block 2+3 QL(2+3)

Intervention Type: PROCEDURE

0.2 percent bupivacaine solution of fifteen milliliters were administered at each injection site, with the needle being inserted once on each side

Interventions

Epidural analgesia (EA) only group

The epidural needle will be inserted into the lumbar epidural space at the level of L2-3 intervertebral space.

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Sohag University

OTHER

Sponsor Role: lead

Responsible Party

Hatem Awaga

Lecturer of Obstetrics and Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Sohag University, Medical school

Sohag, , Egypt

Sohag University hospital

Sohag, , Egypt

Countries

Egypt

Other Identifiers

Soh-Med-23-09-6PD

Identifier Type: -

Identifier Source: org_study_id