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

NCT06451354 | Completed

• 1 other identifier: 35439/4/22
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Postoperative morphine consumption

  The rescue analgesia will be morphine IV bolus 3 mg with 5-minute lock out interval when Numeric Rating Scale (NRS)\>3, can be repeated till NRS˂3 guided with the occurrence of complication.

  24 hours postoperatively

Secondary Outcomes (4)

• Degree of pain

  24 hours postoperatively

• Time for first request of the rescue analgesia

  24 hours postoperatively

• Complications

  24 hours postoperatively

• Degree of patient satisfaction

  24 hours postoperatively

Study Arms (4)

Control group

NO INTERVENTION

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

Erector spinae plane block group

EXPERIMENTAL

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.

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

Posterior Quadratus lumborum plane block group

EXPERIMENTAL

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).

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

Lateral Transversus abdominis plane block group

EXPERIMENTAL

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.

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

Interventions

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

Erector spinae plane block group

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

Posterior Quadratus lumborum plane block group

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

Lateral Transversus abdominis plane block group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women undergoing elective cesarean section under spinal anesthesia.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

Location

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Kafrelsheikh University, Egypt.

Study Record Dates

• First Submitted: June 2, 2024
• First Posted: June 11, 2024
• Study Start: August 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)