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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06451354
Other study ID # 35439/4/22
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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