Postoperative Analgesia After Cesarean Section; Comparison Among Ultrasound Guided Erector Spinae, Quadratus Lumborum or Transversus Abdominis Plane Blocks

NCT ID: NCT06451354

Last Updated: 2024-12-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-08-01

Brief Summary

The aim of this prospective randomized controlled study is to compare the analgesic efficacy of the ultrasound-guided erector spinae plane block, ultrasound-guided quadratus lumborum plane block, and ultrasound-guided transversus abdominis plane block in patients undergoing elective cesarean section.

Detailed Description

Acute postpartum pain is a key determinant of maternal satisfaction; may lead to persistent postoperative pain.

Opioids are used to control severe pain. However, they have many common side effects as sedation, dizziness, nausea, vomiting, constipation, physical dependence, tolerance, and respiratory depression.

Transversus abdominis plane (TAP) block is a regional injection of local anesthetic between the transversus abdominis and internal oblique muscle planes. TAP block affects the sensory nerves of the anterolateral abdominal wall (T6-L1) that innervate the abdomen. TAP block is an easy technique, and decreases postoperative pain and opioid consumption.

Erector Spinae Plane block (ESPB), first described for analgesia in thoracic neuropathic pain has also been reported for the management of other causes of acute postoperative pain.

Quadratus Lumborum block (QLB) differ from the transversus abdominis plane block (TAP) it is a block of the posterior abdominal wall. It is also referred to as an inter fascial plane block because it requires the injection of a local anesthetic into the thoracolumbar fascia (TLF).

Conditions

Postoperative Analgesia; Cesarean Section; Erector Spinae Block; Quadratus Lumborum Block; Transversus Abdominis Plane Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Control group

Patients will receive the standard spinal anesthesia with 0.5% hyperbaric bupivacaine (2.2ml)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Erector spinae plane block group

Patients will receive bilateral ultrasound-guided erector spinae plane block after spinal anesthesia and at the end of surgery. The erector spinae plane block will be performed by using bupivacaine 0.25% (20 ml in each side). Erector spinae plane block will be performed at the level of T9.

Group Type: EXPERIMENTAL

Erector spinae plane block (20 ml bupivacaine 0.25% in each side)

Intervention Type: OTHER

Patients will receive bilateral ultrasound-guided erector spinae plane block after spinal anesthesia and at the end of surgery. The erector spinae plane block will be performed by using bupivacaine 0.25% (20 ml in each side). Erector spinae plane block will be performed at the level of T9.

Posterior Quadratus lumborum plane block group

Patients will receive bilateral ultrasound-guided quadratus lumborum plane block after spinal anesthesia at the end of surgery. The quadratus lumborum plane block will be performed by using bupivacaine 0.25% (20 ml in each side).

Group Type: EXPERIMENTAL

Posterior Quadratus lumborum plane block (20 ml bupivacaine 0.25% in each side)

Intervention Type: OTHER

Patients will receive bilateral ultrasound-guided quadratus lumborum plane block after spinal anesthesia at the end of surgery. The quadratus lumborum plane block will be performed by using bupivacaine 0.25% (20 ml in each side).

Lateral Transversus abdominis plane block group

Patients will receive bilateral ultrasound-guided transversus abdominis plane block after spinal anesthesia at the end of surgery. The transversus abdominis plane block will be performed by using bupivacaine 0.25% (20 ml in each side) to the lateral abdominal wall in the mid-axillary line, between the lower costal margin and iliac crest.

Group Type: EXPERIMENTAL

Lateral Transversus abdominis plane block (20 ml bupivacaine 0.25% in each side)

Intervention Type: OTHER

Patients will receive bilateral ultrasound-guided transversus abdominis plane block after spinal anesthesia at the end of surgery. The transversus abdominis plane block will be performed by using bupivacaine 0.25% (20 ml in each side) to the lateral abdominal wall in the mid-axillary line, between the lower costal margin and iliac crest.

Interventions

Erector spinae plane block (20 ml bupivacaine 0.25% in each side)

Patients will receive bilateral ultrasound-guided erector spinae plane block after spinal anesthesia and at the end of surgery. The erector spinae plane block will be performed by using bupivacaine 0.25% (20 ml in each side). Erector spinae plane block will be performed at the level of T9.

Intervention Type: OTHER

Posterior Quadratus lumborum plane block (20 ml bupivacaine 0.25% in each side)

Patients will receive bilateral ultrasound-guided quadratus lumborum plane block after spinal anesthesia at the end of surgery. The quadratus lumborum plane block will be performed by using bupivacaine 0.25% (20 ml in each side).

Intervention Type: OTHER

Lateral Transversus abdominis plane block (20 ml bupivacaine 0.25% in each side)

Patients will receive bilateral ultrasound-guided transversus abdominis plane block after spinal anesthesia at the end of surgery. The transversus abdominis plane block will be performed by using bupivacaine 0.25% (20 ml in each side) to the lateral abdominal wall in the mid-axillary line, between the lower costal margin and iliac crest.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years.
• American Society of Anesthesiologists (ASA) classification II.
• Female patients scheduled for elective cesarean section under spinal anesthesia.

Exclusion Criteria

• Patient refusal.
• Patients who are taking analgesics for chronic illness or have history of substance abuse.
• Patients who are unable to describe their postoperative pain (e.g., language barrier or neuropsychiatric disorder).
• Patients with a history of coagulopathy.
• Patients weight less than 60 kilograms.
• Patient height less than 150 cm.
• Patients with known local anesthetics and opioid allergy.
• Patients with infection at the site of the needle puncture.
• Patients with major respiratory, cardiac, renal, or hepatic disorders.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kafrelsheikh University

OTHER

Sponsor Role: lead

Responsible Party

Hasnaa Gamal Khafagy

Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelsheikh University, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, Egypt

Countries

Egypt

Other Identifiers

35439/4/22

Identifier Type: -

Identifier Source: org_study_id