Ultrasound Guided Retrolaminar Versus Erector Spinae Plane Block for Postoperative Analgesia

Analgesia Clinical Trial

Official title:

Ultrasound Guided Retrolaminar Versus Erector Spinae Plane Block for Postoperative Analgesia in Modified Radical Mastectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04531215
• Other study ID #: 6236
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: April 1, 2024

Study information

• Verified date: February 2024
• Source: Zagazig University
• Contact: Alshaimaa Kamel, M.D
• Phone: 01005593169
• Email: AlshaimaaKamel80[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Thoracic epidural anesthesia (TEA) and paravertebral block (PVB) have been utilized to give perioperative regional anesthesia in the trunk. TEA is technically troublesome in some cases, and is associated with a danger of serious complications, such as epidural hematoma, nerve injury, and hypotension. PVB has the benefit of perception of the needle position using ultrasonography. However, PVB is also additionally connected with a danger of serious complications, such as pneumothorax, hypotension, or nerve injury. Newer approaches to deal with PVB have been the focal point of numerous techniques lately; these methodologies incorporate retrolaminar block (RLB) and erector spinae plane block (ESPB)

Description:

Modified radical mastectomy is one of the commonly performed breast surgery. Postoperative pain following mastectomy should be minimized, as in a number of women it may chronically persist for months in the form of post-mastectomy pain syndrome.

Morphine administration for acute pain after mastectomy surgery has many side effects. Regional block techniques as para-vertebral block and thoracic epidural anesthesia have possible complications and technical difficulties.

The new alternative regional techniques such as erector spinae plane block and retrolaminar block are clinical trials for providing a safe and easy with good hemodynamic and recovery profile with adequate perioperative analgesia for a large section of patients undergoing mastectomy operation in order to reduce opioids consumption and subsequently avoid opioid-related adverse effects.

As percent of post-operative rescue analgesia is 16.7% and 60% for RLB group and ESPB group respectively. So, sample size is 46 patients (23 patients in each group). Sample was calculated using OPEN EPI program with confidence level 95% and power 80%.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: April 1, 2024
• Est. primary completion date: March 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 64 Years

Eligibility

Inclusion Criteria:

• Patient acceptance.

• 21 - 64 years of age.

• American Society of Anesthesiologist physical status class I,II.

• Body Mass Index 25-35 kg/m2.

• Female patient undergoing elective unilateral modified radical mastectomy under general anesthesia.

Exclusion Criteria:

• Coagulation disorders or anticoagulant therapy.

• Known allergy to study drugs (Bupivacaine, Fentanyl)

• Infection at the injection site.

• Patients having chronic pain or on pain treatment.

• Advanced renal, respiratory, hepatic or cardiovascular disorders.

• Uncooperative patients.

• Duration of surgery > 3hours.

• Pregnant or lactating females.

• Metastasis.

Related Conditions & MeSH terms

• Analgesia

Intervention

Drug:
• ultrasound guided Retrolaminar Block
ultrasound guided Retrolaminar Block (RLB) with 20 ml (0.5% Bupivacaine) plus 5 mic/ml Adrenaline (1:200,000) at the level of T4 of the surgical side
• ultrasound guided Erector Spinae Plane
ultrasound guided Erector Spinae Plane Block (ESPB) with 20 ml (0.5% Bupivacaine) plus 5 mic/ml Adrenaline (1:200,000) at the level of T4 of the surgical side.

Locations

Country	Name	City	State
Egypt	Zagazig University, Faculty of medicine	Zagazig

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total fentanyl dose.	The anesthesiologist will administer intravenous fentanyl 0.5 µg/kg when the heart rate or blood pressure of the patients increased >20% from basal measurements after exclusion of other causes.	from induction to end of surgery
Secondary	pain intensity by Visual Analogue Scale	• Static and dynamic pain scores (VAS) at 30 minutes, 2, 4, 8, 12, 18 and 24 hours post-operatively.; pain intensity will be evaluated by Visual Analogue Scale (VAS). VAS is a 10 cm horizontal line labeled "no pain" at one end and "worst pain" imaginable on the other end. The patient will be asked to mark on this line where the intensity of the patient lies.	at 30 minutes then at 2, 4, 8, 12, 18 and 24 hours post-operatively.
Secondary	Time of requirement of rescue dose of Fentanyl.	Time of requirement of rescue dose of Fentanyl.	up to 24hour postoperative
Secondary	Total amount of postoperative Fentanyl	Total amount of Fentanyl consumed during the first 24 hours after surgery.	up to 24hour postoperative
Secondary	Post-operative nausea and vomiting	• Post-operative nausea and vomiting will be noticed, recorded using a categorical scoring system (0 = none, 1 = mild, 2 = moderate, 3 = severe) and treated, Ondansetron 4 mg IV will be administered in case of reported nausea and/or vomiting	up to 24hour postoperative
Secondary	Complications including hypotension MAP < 60, bradycardia HR < 60b/m, nausea, vomiting and allergic reactions.	Complications including hypotension MAP < 60, bradycardia HR < 60b/m, nausea, vomiting and allergic reactions.	up to 24hour postoperative
Secondary	Overall patient satisfaction	• Overall patient satisfaction at the end of the 24 hours post-operative using short assessment patient satisfaction scale (SAPS scale fully satisfied, neutral satisfied or unsatisfied)	up to 24hour postoperative