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Ultrasound Guided Lumbar Erector Spinae Block Using Bupivacaine - Magnesium Sulphate Versus Bupivacaine - Dexamethasone in Total Hip Replacement Surgery

Ultrasound Guided Lumbar Erector Spinae Block Using Bupivacaine - Magnesium Sulphate Versus Bupivacaine - Dexamethasone in Total Hip Replacement Surgery

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07418671
Enrollment
66
Registered
2026-02-18
Start date
2025-05-01
Completion date
2025-11-25
Last updated
2026-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erector Spinae Plane Block, Post-operative Pain, Total Hip Arthroplasty (THA)

Brief summary

The current study was done to evaluate the effect of adding dexamethasone and magnesium sulfate to bupivacaine as adjuvants in an ultrasound-guided erector spinae block for patients undergoing total hip arthroplasty (THA), and to assess their impact on the timing of the first request for analgesia and on overall postoperative analgesic requirements.

Detailed description

This study aimed to appraise the addition of dexamethasone and magnesium sulfate to bupivacaine as adjuvants by ultrasound-guided ESP block in patients having undergone total hip arthroplasty (THA) and its effect on the first analgesic request, total analgesic requirements. This study was a prospective clinical study carried out to improve pain control after total hip arthroplasty (THA), which is a major orthopedic surgery often associated with significant postoperative discomfort. It is done to determine whether adding two commonly available medications-dexamethasone and magnesium sulfate-to the standard local anesthetic drug bupivacaine could enhance the effectiveness of the erector spinae plane (ESP) block. The study included adult patients scheduled for elective total hip replacement surgery. All participants were carefully evaluated before enrollment to ensure they met specific inclusion criteria, such as appropriate age range, general health status, and absence of contraindications to regional anesthesia. Patients with conditions like known allergy to study drugs, severe coagulation problems, local infection at the injection site, or major systemic illness were excluded in order to maintain safety and reliability. Participants were randomly divided into three groups. Each group received an ESP block under ultrasound guidance at the lumbar level at the end of surgery. Ultrasound was used to accurately identify the muscles, bones, and nerves of the lower back so that the anesthetic solution could be injected in the correct tissue plane. The groups are: One group received bupivacaine plus saline (control group). A second group received bupivacaine with dexamethasone. A third group received bupivacaine with magnesium sulfate. Following completion of the ESP block, patients were placed in a comfortable supine position and were subjected to continuous clinical observation to detect any procedure-related immediate complications. In the postoperative period, all study groups received the same standardized analgesic protocol and routine perioperative management to ensure uniformity of care and minimize bias. Assessment of pain severity was performed at predetermined regular intervals using validated scoring systems such as the Visual Analogue Scale. The precise duration of analgesia was determined by documenting the time to first postoperative analgesic request for each patient. Nursing staff recorded all additional analgesic medications administered during the first 24 hours after surgery, including total opioid consumption and rescue non-opioid analgesic requirements. Hemodynamic parameters, level of sedation, and possible adverse effects-such as postoperative nausea and vomiting, dizziness, local discomfort, hematoma formation, or signs of infection at the puncture site-were carefully monitored and documented. All collected clinical and laboratory data were subsequently coded and prepared for detailed statistical analysis in order to compare the efficacy of the different bupivacaine-adjuvant combinations in enhancing postoperative pain control after total hip arthroplasty.

Interventions

COMBINATION_PRODUCTBupivacaine-Magnesium Sulphate

Bupivacaine plus Magnesium Sulphate (MgSO4) as adjuvant

COMBINATION_PRODUCTBupivacaine-Dexamethasone

Bupivacaine plus Dexamethasone as adjuvant

COMBINATION_PRODUCTBupivacaine-Saline

Bupivacaine plus Saline as control

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Physical status: ASA 1 or 2. * Age \> 21 * Height 160 to 190 cm. * Body Mass Index (BMI) \< 40.

Exclusion criteria

* Refusing to participate in the study. * Coagulopathy. * Patients with history of drug allergies to study drugs. * Inability to cooperate. * Local disease as inflammation or infections at the site of puncture. * Uncontrolled diabetes, significant cardiopulmonary disease, and mental illness.

Design outcomes

Primary

MeasureTime frameDescription
Post-operative analgesia duration24-HOURSPost-operative analgesia duration, which is measured as the time to the first analgesic request by the patient

Secondary

MeasureTime frameDescription
Total postoperative opioid consumption12 HOURSthe total dose of pethidine required by the patient within the first 12 hours after surgery
Pain Intensity using Visual Analogue Pain Scale (VAS)24-HOURSAssessment of pain levels using the Visual Analogue Pain Scale every 2 hours for a total of 24 hours
Hemodynamic stability24-HOURSMonitoring for any adverse effects on heart rate
Postoperative complications24-HOURSMonitoring for issues such as bleeding, hematoma, or local anesthetic toxicity over the first 24 hours

Countries

Egypt

Contacts

STUDY_CHAIRAshraf A Abouslemah, PhD

Ain Shams University

STUDY_DIRECTORAhmed F Abdelraouf, PhD

Ain Shams University

PRINCIPAL_INVESTIGATORSameh A Hosny, MSc

Ain Shams University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026