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Abstract
Background:
Postoperative pain management is a crucial component of patient care following breast conservative surgery. This study compares the efficacy of ultrasound-guided Erector Spinae Plane Block (ESPB) and Local Wound Infiltration (LWI) in managing acute postoperative pain in these surgeries.
Objectives:
This randomized, double-blinded, controlled clinical trial aims to compare the analgesic efficacy and safety of ultrasound-guided ESPB and LWI in patients undergoing breast conservative surgery.
Patients and methods:
Adult female patients (aged 18-75, ASA II) scheduled for breast conservative surgery were randomly assigned to either the ESPB or LWI group. The primary outcome was total morphine consumption in the first 24 hours postoperatively. Secondary outcomes included; intraoperative fentanyl consumption, hemodynamic parameters (mean arterial blood pressure and heart rate), time of first rescue analgesia, postoperative pain scores, the incidence of postoperative nausea and vomiting (PONV) and patient satisfaction. Complications such as local anesthetic toxicity and respiratory depression were also assessed.
Key Words:
Erector Spinae Plane Block (ESPB), Local wound infiltration, Postoperative analgesia, Breast conservative surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 (experimental group): will receive US guided ESPB | Experimental |
| |
| Group 2 (controlled group): will receive local wound infiltration | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Erector Spinae Plane Block | Procedure | Typical ESPB |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total amount of morphine consumed postoperatively for 24 hours. | Total amount of morphine consumed postoperatively for 24 hours (mg/kg) | up to 24 hours postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Total amount of fentanyl consumed intraoperatively | Total amount of fentanyl consumed intraoperatively (mic/kg) | Perioperative/Periprocedural |
| Hemodynamics: heart rate intraoperatively at 30-minute intervals in comparison to baseline readings. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Institute | Cairo | Egypt |
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Randomized Double Blinded Comparative Study
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| Local Wound Infiltration | Procedure | Preemptive Local Wound Infiltration |
|
Hemodynamics: heart rate intraoperatively at 30-minute intervals in comparison to baseline readings (beats/min)
| Perioperative/Periprocedural |
| Hemodynamics: mean arterial blood pressure intraoperatively at 30-minute intervals in comparison to baseline readings. | Hemodynamics: mean arterial blood pressure intraoperatively at 30-minute intervals in comparison to baseline readings (mmHg) | Perioperative/Periprocedural |
| Heart rate at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively. | Heart rate at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively (beats/min) | at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively. |
| Mean arterial blood pressure at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively. | Mean arterial blood pressure at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively (mmHg) | at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively. |
| The visual analog scale (VAS) (at rest and during movement) at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively. | The visual analog scale (VAS) is a pain rating scale first used by Hayes and Patterson in 1921. Scores are based on self-reported measures of symptoms that are recorded with a single handwritten mark placed at one point along the length of a 10-cm line that represents a continuum between the two ends of the scale "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10cm) | at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively. |
| Postoperative nausea and vomiting (PONV) as side effects of morphine. | 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). | up to 24 hours postoperative |
| Time of first rescue analgesia intra-operative (Fentanyl) | Time of first rescue analgesia (min) | up to 24 hours postoperative |
| Time of first rescue analgesia post-operative (Morphine) | Time of first rescue analgesia (hrs.) | up to 24 hours postoperative |
| Complications such as local anaesthetic systemic toxicity, pneumothorax and arterial puncture. (US check postoperative). | Complications such as local anaesthetic systemic toxicity, pneumothorax and arterial puncture. (US check postoperative). | up to 24 hours postoperative |
| Morphine related complications such as respiratory depression, urine retention or pruritic | Morphine related complications such as respiratory depression, urine retention or pruritic | up to 24 hours postoperative |
| Patient satisfaction the patient will be classified in this group into satisfied or not. | Patient satisfaction the patient will be classified in this group into satisfied or not. | up to 24 hours postoperative |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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