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

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06451354
• Other study ID #: 35439/4/22
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: August 1, 2024

Study information

• Verified date: June 2024
• Source: Kafrelsheikh University
• Contact: Hasnaa G khafagy, Master
• Phone: 00201098830555
• Email: hasnaa_gamal[@]med.kfs.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: August 1, 2024
• Est. primary completion date: August 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• 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.
• 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).
• 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.

Locations

Country	Name	City	State
Egypt	Kafrelsheikh University	Kafr Ash Shaykh	Kafrelsheikh

Sponsors (1)

Lead Sponsor	Collaborator
Kafrelsheikh University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Degree of pain	Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed at T1, 2, 4, 6, 12, 18, and 24 h postoperative.	24 hours postoperatively
Secondary	Time for first request of the rescue analgesia	Time for first request of the rescue analgesia will be assessed from the end of surgery to first dose of morphine administrated.	24 hours postoperatively
Secondary	Complications	Complications such as local anesthetic systemic toxicity (LAST), bradycardia, hypotension, nausea, vomiting, respiratory depression or any other complication will be recorded.	24 hours postoperatively
Secondary	Degree of patient satisfaction	Degree of patient satisfaction will be assessed using 4-point scale (1, excellent; 2, good; 3, fair; 4, poor).	24 hours postoperatively