Local Wound InfiltrationNCT07301840
Ultrasound-guided Erector Spinae Plane Block Versus Local Wound Infiltration in Breast Conservative Surgery
A study testing Erector Spinae Plane Block and Local Wound Infiltration in people with Local Wound Infiltration and Erector Spina Plan Block, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Local Wound Infiltration, Erector Spina Plan Block, Nerve Block/Methods
- What is being tested?
- Erector Spinae Plane Block and Local Wound Infiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Aug 2024to 23 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided Erector Spinae Plane Block Versus Local Wound Infiltration in Breast Conservative Surgery, Randomized Double Blinded Comparative Study
Abstract
Background:
Read more
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
- Conditions
- Local Wound Infiltration, Erector Spina Plan Block, Nerve Block/Methods, Post Operative Analgesia, Pain Management
- Being tested
- Erector Spinae Plane Block, Local Wound Infiltration
- Keywords
- Erector Spinae Plane Block, Local wound infiltration, Postoperative analgesia, Breast conservative surgery
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
Typical ESPB
Local Wound InfiltrationProcedure or surgery
Preemptive Local Wound Infiltration
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (experimental group): will receive US guided ESPB | Experimental | Not described Receives: Procedure: Erector Spinae Plane Block |
| Group 2 (controlled group): will receive local wound infiltration | Active comparator | Not described Receives: Procedure: Local Wound Infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total amount of morphine consumed postoperatively for 24 hours.
Total amount of morphine consumed postoperatively for 24 hours (mg/kg)
Measured: up to 24 hours postoperative
Secondary outcomes (12)
Total amount of fentanyl consumed intraoperatively
Total amount of fentanyl consumed intraoperatively (mic/kg)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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).
Measured: up to 24 hours postoperative
Time of first rescue analgesia intra-operative (Fentanyl)
Time of first rescue analgesia (min)
Measured: up to 24 hours postoperative
Time of first rescue analgesia post-operative (Morphine)
Time of first rescue analgesia (hrs.)
Measured: 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).
Measured: 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
Measured: 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.
Measured: up to 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start21 Aug 2024
- Primary completion23 Dec 2024
- Study completion23 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local Wound InfiltrationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Double Blinded Comparative Study
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tasneem Hassan El-Tohamy, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07301840
- Sponsor's protocol ID
- MS-433-2024
- Status last verified
- Dec 2025
- First submitted
- 13 Nov 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Erector Spinae Plane Block Versus Local Wound Infiltration in Breast Conservative Surgery, Randomized Double Blinded Comparative Study
- ClinicalTrials.gov ID
- NCT07301840
- Acronym / sponsor ID
- MS-433-2024
- Conditions
- Local Wound Infiltration, Erector Spina Plan Block, Nerve Block/Methods, Post Operative Analgesia, Pain Management
- Keywords
- Erector Spinae Plane Block, Local wound infiltration, Postoperative analgesia, Breast conservative surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 21 Aug 2024 (actual)
- Primary completion
- 23 Dec 2024 (actual)
- Study completion
- 23 Dec 2024 (actual)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Double Blinded Comparative Study
| Arm | Type | Receives |
|---|---|---|
| Group 1 (experimental group): will receive US guided ESPB | Experimental | Procedure: Erector Spinae Plane Block |
| Group 2 (controlled group): will receive local wound infiltration | Active comparator | Procedure: Local Wound Infiltration |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Erector Spinae Plane BlockTypical ESPB | Procedure or surgery | Group 1 (experimental group): will receive US guided ESPB |
| Local Wound InfiltrationPreemptive Local Wound Infiltration | Procedure or surgery | Group 2 (controlled group): will receive local wound infiltration |
Primary outcome
Total amount of morphine consumed postoperatively for 24 hours.
Time frame: up to 24 hours postoperative
Total amount of morphine consumed postoperatively for 24 hours (mg/kg)
12 secondary outcomes
Total amount of fentanyl consumed intraoperatively
Time frame: Perioperative/Periprocedural
Hemodynamics: heart rate intraoperatively at 30-minute intervals in comparison to baseline readings.
Time frame: Perioperative/Periprocedural
Hemodynamics: mean arterial blood pressure intraoperatively at 30-minute intervals in comparison to baseline readings.
Time frame: Perioperative/Periprocedural
Heart rate at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively.
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.
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.
Time frame: at 0, 4, 8, 12, 16, 20 and 24 hours postoperatively.
Postoperative nausea and vomiting (PONV) as side effects of morphine.
Time frame: up to 24 hours postoperative
Time of first rescue analgesia intra-operative (Fentanyl)
Time frame: up to 24 hours postoperative
Time of first rescue analgesia post-operative (Morphine)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Erector Spinae Plane Block and Local Wound Infiltration in people with Local Wound Infiltration and Erector Spina Plan Block, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total amount of morphine consumed postoperatively for 24 hours. (time frame: up to 24 hours postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.