Ultrasound-guided Erector Spinae Plane Block Versus Local Wound Infiltration in Breast Conservative Surgery

Cairo University66 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Local Wound Infiltration Erector Spina Plan Block

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Total amount of morphine consumed postoperatively for 24 hours.

Total amount of morphine consumed postoperatively for 24 hours (mg/kg)

Time frame: up to 24 hours postoperative

Secondary Outcomes

Total amount of fentanyl consumed intraoperatively

Total amount of fentanyl consumed intraoperatively (mic/kg)

Time frame: Perioperative/Periprocedural

Hemodynamics: heart rate intraoperatively at 30-minute intervals in comparison to baseline readings.

Hemodynamics: heart rate intraoperatively at 30-minute intervals in comparison to baseline readings (beats/min)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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)

Time frame: 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).

Time frame: up to 24 hours postoperative

Time of first rescue analgesia intra-operative (Fentanyl)

Time of first rescue analgesia (min)

Time frame: up to 24 hours postoperative

Time of first rescue analgesia post-operative (Morphine)

Time of first rescue analgesia (hrs.)

Time frame: up to 24 hours postoperative

Complications such as local anaesthetic systemic toxicity, pneumothorax and arterial puncture. (US check postoperative).

Time frame: up to 24 hours postoperative

Morphine related complications such as respiratory depression, urine retention or pruritic

Time frame: up to 24 hours postoperative

Patient satisfaction the patient will be classified in this group into satisfied or not.

Time frame: up to 24 hours postoperative

Ultrasound-guided Erector Spinae Plane Block Versus Local Wound Infiltration in Breast Conservative Surgery

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes