Clinical trial
A Comparative Study Between Preoperative Erector Spinae Plane Block Versus Preoperative Paravertebral Plane Block in Decreasing Post Mastectomy Pain Syndrome. A Randomized Controlled Study.
Name
AP2303-301-0007
Description
Breast cancer is considered the commonest malignancy affecting women with an incidence exceeding one million cases per year. Although it has a favorable prognosis with improved lines of treatment, some complications may still disturb the patient's life quality. One of these complications is post-mastectomy pain syndrome (PMPS) .Regional Anaesthesia (RA) is considered one of the most effective methods in reducing acute pain after breast surgeries, these include pectoral nerves block (PECS), serratus anterior plane block (SAPB), paravertebral plane block (PVPB) and erector spinae plane block (ESPB) . Our study is aiming for comparing the effect of preoperative PVPB versus preoperative ESPB in the prevention of PMPS in patients undergoing unilateral breast surgeries.
Trial arms
Trial start
2024-07-01
Estimated PCD
2024-10-01
Trial end
2025-02-01
Status
Not yet recruiting
Treatment
Paravertebral plane block
With the patients are placed in the sitting position, counting down from C7 spinous process, a high frequency linear ultrasound probe is placed on the spinous process in the parasagittal plane at T5 level and then is slided laterally 2-3 cm to make the transverse processes clearly visualized . Under aseptic conditions, a 22-gauge block needle (50mm, B.Braun, Germany) is inserted using in-plane technique toward the paravertebral space, immediately above the pleura and below the superior costotransverse ligament. The position of the needle is confirmed by the descent of the pleura when injecting 2 to 3 ml of saline solution for hydrolocalization. Then 0.3ml/kg of bupivacaine 0.25% is injected under ultrasound guidance. Block success is defined as reduced sensitivity to cold and pinprick stimuli as compared with the contralateral side 20 minutes after local anesthetic injection.
Arms:
Paravertebral Block Group
Other names:
PVPB
Erector spinae plane block
With the patients are placed in the sitting position, counting down from C7 spinous process, a high frequency linear ultrasound probe is placed on the spinous process in the parasagittal plane at T5 level and then is slided laterally 2-3 cm to make the tips of the transverse processes clearly visualized . The following muscles seen from superficial to deep layer are trapezius, rhomboid major and erector spinae muscles. Under aseptic conditions, a 22-gauge block needle (50mm, B.Braun, Germany) is inserted using in-plane technique to reach the interfascial plane between the transverse process and the erector spinae muscle. Following confirmation of the accurate position of the needle tip with 3-5 ml normal saline solution, 0.3ml/kg of bupivacaine 0.25% is injected under ultrasound guidance. Block success is defined as reduced sensitivity to cold and pinprick stimuli as compared with the contralateral side 20 minutes after local anesthetic injection.
Arms:
Erector Spinae Block Group
Other names:
ESPB
Intravenous morphine, ketorlac and paracetamol
• In the control group only we add 10mg intravenous morphine, 30 mg intravenous ketorlac and 1 gm intravenous paracetamol for analgesia.
Arms:
Control Group
Other names:
IV analgesics
Size
51
Primary endpoint
The primary outcome is to assess the incidence of PMPS 3 months after surgery.
3 months
Eligibility criteria
Inclusion Criteria:
* Age ≥ 18 years and ≤ 60 years old.
* Female patients ASA ΙΙ, ΙΙΙ.
* Female patients scheduled for unilateral breast surgeries.
Exclusion Criteria:
* Patient refusal.
* Patients have sepsis
* Patients known to have allergy against local anesthetics.
* Patients with prior surgery in areas above or below the clavicle or in the axillary region.
* Patients with opioid dependence, alcohol or drug abuse.
* Patient with coagulopathy.
* Patients with psychiatric illness that prevent them from proper pain perception and assessment.
* ASA 4 or higher.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 51, 'type': 'ESTIMATED'}}
Updated at
2024-06-28
1 organization
1 product
1 indication
Organization
National Cancer Institute, EgyptIndication
Chronic Postoperative Pain