Anterior Quadratus Lumborum Block Versus Erector Spinae Plane Block After Elective Cesarean Section

NCT05254093 | Completed

• 1 other identifier: MD-60-2021
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

Cesarean section is the one of the most common surgical procedures. Inadequate pain management is associated with increased morbidity, costs, and maternal dissatisfaction. Furthermore, effective postoperative pain management enables mothers to care for their newborn infants. Systemic and neuraxial opioids are the cornerstone of postoperative pain management; however, opioids are associated with significant side effect such as respiratory depression, urine retention, constipation, and itching. To reduce the postoperative opioids requirement and subsequently their side effects, multimodal regimen is advice including neuraxial anesthesia, neuraxial morphine, regular administration of non-opioids analgesia (non-steroidal anti-inflammatory drugs and acetaminophen) and planned use of opioid for breakthrough pain. The addition of peripheral nerve blocks to the multimodal analgesic plan was found to reduced postoperative opioids requirement in non-obstetric procedures. Quadratus lumborum (QLB) and erector spinae plane (ESPB) blocks are relatively new techniques for peripheral nerve block and showed promising results in managing pain after Cesarean delivery. There are several types of QLB that had been described. Lateral (QLB1), posterior (QLB2), and anterior (QLB3) quadratus lumborum blocks been studied in cesarean delivery and were found to reduce opioids requirement when compared against placebo. Cadaver studies suggest that local anesthetic deposition at QLB1 diffuses mainly to the transversus abdominis muscle plane while, at QLB2, and at QLB3 spread may occur into the thoracic paravertebral space providing additional visceral pain control. ESPB can provide both visceral and somatic analgesia due to anterior spread to the paravertebral space. ESPB was found to reduce postoperative opioids requirement in comparison to transversus abdominis plane block and intrathecal morphine. To the best of our knowledge, there is no published data comparing the analgesic effect of QLB3 (anterior QL) and ESPB after elective cesarean delivery.

Conditions

Cesarean Section; Postoperative Analgesia

Outcome Measures

Primary Outcomes (1)

• Time to first analgesic requirement

  hours

  15 minutes after intervention till 24 hours after suregery

Secondary Outcomes (5)

• numeric pain scale

  at 0.5, 1, 2, 4, 6, 18, 24 hours postoperative

• postoperative morphine requirement

  15 minutes after intervention till 24 hours after surgery

• time to independent movement

  15 minutes after intervention till 24 hours after surgery

• obstetric quality-of-recovery score

  24 hours after surgery

• opioid related complication

  24 hours after surgery

Study Arms (3)

group A

NO INTERVENTION

group B

ACTIVE COMPARATOR

Other: Quadratus lumborum block

group C

ACTIVE COMPARATOR

Other: erector spinae plane block

Interventions

Quadratus lumborum block OTHER

quadratus lumborum block, anterior approach using a curvilinear (5-8MHz) transducer. The transducer will be positioned transverse above the iliac crest at the posterior axillary line and slided posteriorly till the Shamrock sign is identified (the transvers process represent the stem and the attached erector spinae, QL and Psoas major muscles represent the three leaves). A 22 G, 100 mm needle will be advanced in-plane from lateral to medial through the QL muscle to reach the inter-fascial plane between the QL and psoas major muscles, posterior to the transversalis fascia. After ensuring negative aspiration, the local anesthetic solution (20 ml of 0.25% isobaric bupivacaine) will be injected anterior to the QL muscle. The procedure will be repeated on the opposite side of the back

group B

erector spinae plane block OTHER

the block will be given at the level of the 9th thoracic transverse process using a linear 6-13 MHz ultrasound transducer. The transducer will be positioned vertically 3 cm to the side of the midline to visualize the muscles of the back, the transverse process, and the pleura between the two transverse processes. Then, a 22G 10-mm needle will be introduced in the cranial-caudal direction toward the transverse process (T9) using the in-plane method till the needle tip crosses all the muscles. The tip of needle should be in the plane between the transverse process and the erector spinae muscle. After ensuring negative aspiration, the local anesthetic solution (20 ml of 0.25% isobaric bupivacaine) will be injected below the muscle. The procedure will be repeated on the opposite side of the back

group C

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• full-term, singleton, pregnant women,
• aged 18-35 years,
• scheduled for elective cesarean delivery under spinal anesthesia

You may not qualify if:

• American Society of Anesthesiologists (ASA) physical class III or more
• multiple gestation.
• Patients with a history of allergy to any of the study drugs, ,
• coagulopathy,
• local infection,
• history of chronic pain or
• regular opioid use;
• inability to comprehend the numeric pain scale (NRS);
• and requirement for conversion to general anesthesia after spinal anesthesia

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Kasr Alaini Hospital

Cairo, 11562, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 15, 2022
• First Posted: February 24, 2022
• Study Start: March 1, 2022
• Primary Completion: July 15, 2022
• Study Completion: July 16, 2022
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)