National Cancer Institute
Cairo, 11796, Egypt
Location status: Recruiting
NCT Number: NCT06884852
The aim of this study is to compare the analgesic efficacy of multilevel erector spinae plane block (ESPB) vs thoracic epidural in modified radical mastectomy (MRM) regarding duration of analgesia, postoperative opioid consumption, effect on intraoperative fentanyl consumption, postoperative numerical pain rating scale and quality of life for the next 6 months.
Interested in participating?
Request Info18 year–65 year
Female
Interventional
Not applicable
Cairo, 11796, Egypt
Location status: Recruiting
Breast cancer is the most common malignancy among females. Modified Radical Mastectomy (MRM) is the principal surgical treatment for breast cancer. The standard mode of anesthesia is general anesthesia, in addition to regional blocks for effective postoperative pain control.
Pain is usually managed by narcotics, which have many side effects, including prolonged sedation, increasing incidence of pain recurrence, respiratory depression, nausea & vomiting and paralytic ileus. All requiring close monitoring and in some occasions Intensive Care Unit (ICU) admission. Thoracic epidural and paravertebral blocks are the gold standard techniques. However, both techniques may lead to some serious complications including spinal cord injury, pneumothorax, incompatibility with pre-existing anticoagulation or antiplatelet therapy and hemodynamic instability.
Recently, multiple regional techniques have been used for postoperative thoracic pain control, including that caused by modified radical mastectomy. Interfascial plane blocks are currently the hot topic in management of postoperative pain. One of these blocks is erector spinae plane block (ESPB). It is an interfacial Para spinal plane block that is simple, safe, effective and associated with fewer complications in comparison to the gold standard techniques.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Erector spinae plane block (ESPB) using multilevel injections of bupivacaine 0.25%.
We will inject 15ml at the level of T2 and 15ml at the level of T5.
Other names: Bupivacaine 0.25%
Thoracic epidural block at level of T5 -T6 using 10 ml of bupivacaine 0.25% as a bolus followed by 5 ml bupivacaine 0.25% every 1-2 hours depending on the duration of surgery and the response of the patient.
Other names: Bupivacaine 0.25%
Time frame: 24 hours postoperatively
The average duration of analgesia will be recorded from the end of surgery till the first dose of morphine administrated.
Time frame: 24 hours postoperatively
Patient will be discharged to the ward then rescue analgesia will be given in the form of IV morphine 3 mg boluses if the patient reported Numeric Pain Rating Scale ≥ 4. The total amount of morphine given in 24 hours will be recorded for the two groups.
Time frame: 6 months postoperatively
Incidence of postmastectomy pain syndrome at 1, 3, and 6 months postoperatively will be recorded.
Time frame: Intraoperatively
Fentanyl 1 μg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of the baseline levels.
Time frame: 24 hours Postoperatively
Heart rate will be noted at 4, 8, 12, 16, 20, and 24 hours postoperatively
Time frame: 24 hours Postoperatively
Mean arterial blood pressure will be noted at 4, 8, 12, 16, 20, and 24 hours postoperatively
Time frame: 24 hours Postoperatively
Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be recorded (at rest and during movement) at 0, 4, 8, 12, 16, 20, and 24 hours postoperatively.
Time frame: 24 hours Postoperatively
Postoperative nausea and vomiting (PONV) will be rated on a four-point verbal scale; (none =no nausea, mild = nausea but no vomiting, moderate= vomiting one attack, severe =vomiting > one attack). 0.1 mg/kg of IV ondansetron will be given to patients with moderate or severe postoperative nausea and vomiting.Nausea and vomiting Scores using a four-point verbal scale; on arrival to post-anesthesia care unit (PACU), scoring at 0, 4, 8,12,16,20 and 24 hours postoperatively.
Time frame: 6 months postoperatively
Complications related to the block such as local anesthetics, systemic toxicity, and vascular injury will be recorded
Time frame: 24 hours Postoperatively
Patient will be discharged to the ward then rescue analgesia will be given in the form of IV morphine 3 mg boluses if the patient reported Numeric Pain Rating Scale ≥ 4. The total amount of morphine given in 24 hours will be recorded for the two groups. Morphine-related complications such as respiratory depression, urine retention, or pruritis will be recorded.
Time frame: 24 hours Postoperatively
Patient's satisfaction: the patient will be classified in this group as satisfied or not.
Interested in participating?
Request InfoNational Cancer Institute, Egypt
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