Clinical trial NCT04531215: Ultrasound Guided Retrolaminar Versus Erector Spinae Plane Block for Postoperative Analgesia
Official title: Ultrasound Guided Retrolaminar Versus Erector Spinae Plane Block for Postoperative Analgesia in Modified Radical Mastectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Analgesia
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
First posted: 2020-08-28
Enrollment: 46
Sex: ALL
Minimum age (years): 21
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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)

Detailed 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%.

Eligibility criteria: 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.

Primary outcomes:
measure: Total fentanyl dose.
timeFrame: from induction to end of surgery
Secondary outcomes:
measure: pain intensity by Visual Analogue Scale
timeFrame: at 30 minutes then at 2, 4, 8, 12, 18 and 24 hours post-operatively.
measure: Time of requirement of rescue dose of Fentanyl.
timeFrame: up to 24hour postoperative
measure: Total amount of postoperative Fentanyl
timeFrame: up to 24hour postoperative
measure: Post-operative nausea and vomiting
timeFrame: up to 24hour postoperative
measure: Complications including hypotension MAP < 60, bradycardia HR < 60b/m, nausea, vomiting and allergic reactions.
timeFrame: up to 24hour postoperative
measure: Overall patient satisfaction
timeFrame: up to 24hour postoperative
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University, Faculty of medicine
Study officials:
affiliation: Zagazig University
name: Alshaimaa Kamel, M.D
role: STUDY_CHAIR
References: