Chronic Pain, Mastectomy; Lymphedema, Opioid Use, Regional Anesthesia Morbidity
Conditions
Brief summary
The goal of this clinical trial is to learn if the erector spinae block can reduce the incidence of chronic pain compared to the paravertebral block in adult patients undergoing total mastectomy. The study includes patients aged 18 to 80 years scheduled for mastectomy, with or without axillary dissection. The main questions it aims to answer are: * Does erector spinae block reduce the incidence of chronic pain at 3 months after mastectomy compared to paravertebral block? * Does erector spinae block affect postoperative outcomes such as opioid consumption at 48 hours, pain scores (in PACU, 24 and 48 hours), block performance time, and the incidence of complications, anxiety or depression, and pain intensity at 3 months? Researchers will compare patients receiving erector spinae block to those receiving paravertebral block to determine if erector spinae block provides equivalent or improved outcomes in terms of chronic pain and perioperative measures. Participants will: * Be randomly assigned to receive either erector spinae block or paravertebral block prior to surgery * Undergo total mastectomy (with or without axillary dissection) * Have their pain assessed in the PACU and at 24 and 48 hours postoperatively * Have opioid consumption measured during the first 48 hours after surgery * Be followed up at 3 months to assess chronic pain, pain intensity, and psychological outcomes (anxiety or depression)
Detailed description
Background: Acute post mastectomy pain is a strong predictor of the development of chronic pain. Paravertebral block (PVB) has been shown to reduce the incidence and severity of acute and chronic pain post mastectomy. Despite the use of ultrasound, the performance of this advanced block requires special skills and training due to the proximity of the injection site to the pleura and the spinal cord. Erector spinae block (ESB), a novel regional anesthesia technique, has been shown to be equivalent to PVB in reducing the incidence and severity of acute post-surgical pain. Specific aims: The primary objective of this study is to compare the effect of ESB and PVB on the incidence of chronic pain measured 3 months after mastectomy. Secondary objectives include assessment of cumulative opioid consumption at 48 hours post operatively, pain scores in the PACU as well as at 24 and 48 hours, time needed for performing the block, as well as complications, anxiety or depression at 3 months, pain intensity at 3 months. Methods: This prospective randomized clinical trial will be conducted in the operating rooms at AUBMC. 132 (66 in each group) adult patients scheduled to total mastectomy, with or without axillary dissection, and aging between 18 and 80 will be randomly allocated to 2 groups: The erector spinae group or the paravertebral group. Significance: It has not been demonstrated yet that the ESB is equivalent to the more conventional PVB in reducing the incidence of chronic post mastectomy pain. This study will compare the effect of ESB to PVB in reducing the incidence of chronic pain, which will improve the quality of life of patients undergoing modified radical mastectomy
Interventions
DRUGParavertebral block
Thoracic paravertebral block is performed at the level of T4 or T5 if no axillary procedure is to be performed, and additionally at the level of T2 if axillary procedure is planned. A high-frequency transducer probe connected to an ultrasound (US) machine is positioned in a para-median sagittal plane, approximately 2-2.5 cm lateral to the spinous process at the ipsilateral side of surgery location to localize the transverse process and the paravertebral space. The skin is sterilized and the US probe covered with a sterile cap. A 22-gauge, 100 mm stimuplex nerve block needle is introduced in an in-plane direction. After perforating the costotransverse ligament and confirming negative aspiration of blood, 20ml of a mixture of ropivacaine 0.5% is injected. Anterior displacement of the pleura indicates appropriate spread of local anaesthesia (LA) in the paravertebral space.
DRUGErector Spinae block
The ESB is performed at the level of T4-T5 if no axillary procedure is to be performed, and additionally at the level of T2 (5ml) if axillary procedure is planned. A transducer probe is positioned in a para-median sagittal plane approximately 3 cm lateral to the spinous process at the ipsilateral side of surgery. Following the same sterilization procedure, the 10 cm stimuplex needle is introduced in an in-plane direction. The transverse process of the vertebrae, trapezius muscle, rhomboid major and erector spinae muscle are visualized, and 25 ml of ropivacaine 0.5% mixture is injected after confirming negative aspiration of blood (lower the concentration not to exceed 2 mg/kg ideal body weight). The LA spread lifts the erector spinae muscle off the bony shadow of the transverse process.
Sponsors
American University of Beirut Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult patients between 18 and 80 years old. * Scheduled to total mastectomy with or without axillary dissection * Willing to receive regional anesthesia in addition to GA * ASA classification 1-3
Exclusion criteria
* Previous thoracic surgery with an incision of \>2 cm * Patient's refusal * Allergy to local anesthetics * Pregnant women * Any contraindications to thoracic PVB, including intrathoracic infection, infection at the puncture site, cancer invasion of the puncture site, severe spinal deformity, history of spinal surgery, and severe coagulopathy; anticoagulants intake. * American Society of Anesthesiologists (ASA) classification of 4 or higher, * History of chronic pain or untreated clinical severe depression
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Chronic pain | 3 months after mastectomy | Chronic pain measured using NRS scale (0-10) 3 months after mastectomy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative opioid consumption | Amount of opioids used by the patient 48 hours after the procedure | Cumulative opioid consumption |
| Pain score | Pain score measured using NRS scale (0-10) on arrival to the PACU,12 hour, 24 hour,and 48 hour after the procedure | Pain score measured using NRS scale (0-10) |
| Time needed for performing the block | Time needed for performing the block (Perioperative) | Time needed for performing the block in minutes |
| Complications | Incidence of complications (Yes/No) (Perioperative) | Incidence of complications (Yes/No) |
| Anxiety or depression | Anxiety or depression measured using the Hospital Anxiety and Depression Scale (HADS; range 0-42, with subscales 0-21 each), where higher scores indicate worse anxiety and depression, assessed 3 months after the procedure. | Anxiety or depression measured using HADS |
Countries
Lebanon
Contacts
CONTACTNancy Abou Nafeh, MD
CONTACTThouraya HajAli
PRINCIPAL_INVESTIGATORNancy Abou Nafeh, MD
American University of Beirut Medical Center
Outcome results
None listed