Local Wound Infiltration, Erector Spina Plan Block, Nerve Block/Methods, Post Operative Analgesia, Pain Management
Conditions
Keywords
Erector Spinae Plane Block, Local wound infiltration, Postoperative analgesia, Breast conservative surgery
Brief summary
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
Interventions
PROCEDUREErector Spinae Plane Block
Typical ESPB
PROCEDURELocal Wound Infiltration
Preemptive Local Wound Infiltration
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Randomized Double Blinded Comparative Study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age from 18 to 75 years. * Genders eligible for study: females. * ASA II. * Patients scheduled for breast conservative surgery. * Ability to provide informed consent or, if unable, consent obtained from a legal representative
Exclusion criteria
* Patient refusal. * Inability to provide informed consent. * ASA III-IV. * Known sensitivity or contraindication to drug used in the study (local anesthetics, opioids). * Pregnant or lactating women. * History of psychological disorders and/or chronic pain. 25 * Contraindication to regional anesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy. * Severe respiratory or cardiac disorders. * Advanced liver or kidney disease. * Male patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total amount of morphine consumed postoperatively for 24 hours. | up to 24 hours postoperative | Total amount of morphine consumed postoperatively for 24 hours (mg/kg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hemodynamics: heart rate intraoperatively at 30-minute intervals in comparison to baseline readings. | Perioperative/Periprocedural | Hemodynamics: heart rate intraoperatively at 30-minute intervals in comparison to baseline readings (beats/min) |
| Hemodynamics: mean arterial blood pressure intraoperatively at 30-minute intervals in comparison to baseline readings. | Perioperative/Periprocedural | Hemodynamics: mean arterial blood pressure intraoperatively at 30-minute intervals in comparison to baseline readings (mmHg) |
| Heart rate at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively. | 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) |
| Mean arterial blood pressure at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively. | 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) |
| The visual analog scale (VAS) (at rest and during movement) at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively. | 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) |
| Total amount of fentanyl consumed intraoperatively | Perioperative/Periprocedural | Total amount of fentanyl consumed intraoperatively (mic/kg) |
| Time of first rescue analgesia intra-operative (Fentanyl) | up to 24 hours postoperative | Time of first rescue analgesia (min) |
| Time of first rescue analgesia post-operative (Morphine) | up to 24 hours postoperative | Time of first rescue analgesia (hrs.) |
| Complications such as local anaesthetic systemic toxicity, pneumothorax and arterial puncture. (US check postoperative). | up to 24 hours postoperative | Complications such as local anaesthetic systemic toxicity, pneumothorax and arterial puncture. (US check postoperative). |
| Morphine related complications such as respiratory depression, urine retention or pruritic | up to 24 hours postoperative | Morphine related complications such as respiratory depression, urine retention or pruritic |
| Patient satisfaction the patient will be classified in this group into satisfied or not. | up to 24 hours postoperative | Patient satisfaction the patient will be classified in this group into satisfied or not. |
| Postoperative nausea and vomiting (PONV) as side effects of morphine. | up to 24 hours postoperative | 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). |
Countries
Egypt
Outcome results
None listed