An interventional study of Paravertebral block and Erector Spinae block in Mastectomy; Lymphedema, Chronic Pain and Regional Anesthesia Morbidity, sponsored by American University of Beirut Medical Center. Recruiting at 1 site in Lebanon. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by American University of Beirut Medical Center · Not applicable, Interventional, and Treatment
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:
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:
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
529 studies on the registry are indexed under Lymphedema; 131 are open to participants now.
This study's planned enrollment of 132 is above the median of 50 across 369 interventional studies indexed under Lymphedema.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Paravertebral 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
Drug: Erector Spinae 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.
Also known as: TPVB
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.
Also known as: ESPB
Chronic pain
Chronic pain measured using NRS scale (0-10) 3 months after mastectomy
Time frame: 3 months after mastectomy
Cumulative opioid consumption
Cumulative opioid consumption
Time frame: Amount of opioids used by the patient 48 hours after the procedure
Pain score
Pain score measured using NRS scale (0-10)
Time frame: Pain score measured using NRS scale (0-10) on arrival to the PACU,12 hour, 24 hour,and 48 hour after the procedure
Time needed for performing the block
Time needed for performing the block in minutes
Time frame: Time needed for performing the block (Perioperative)
Complications
Incidence of complications (Yes/No)
Time frame: Incidence of complications (Yes/No) (Perioperative)
Anxiety or depression
Anxiety or depression measured using HADS
Time frame: 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.
Plan to share: No
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