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

February 14, 2026 updated by: Ain Shams University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt, 1181
        • Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group BS (Bupivacaine-Saline): control
Group BS: The group will receive 30 ml 0.25% bupivacaine plus 5 ml normal saline.
Combination product: Bupivacaine-Saline
Bupivacaine plus Saline as control
Active Comparator: Group BM (Bupivacaine-Magnesium)
the group will receive 30 mL 0.25% bupivacaine plus 5ml of 10% MgSO4
Combination product: Bupivacaine-Magnesium Sulphate
Bupivacaine plus Magnesium Sulphate (MgSO4) as adjuvant
Active Comparator: Group BD (Bupivacaine-Dexamethasone)
The group will receive 30 mL 0.25% bupivacaine plus 5 ml normal saline containing 8 mg dexamethasone.
Combination product: Bupivacaine-Dexamethasone
Bupivacaine plus Dexamethasone as adjuvant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative analgesia duration
Time Frame: 24-HOURS
Post-operative analgesia duration, which is measured as the time to the first analgesic request by the patient
24-HOURS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total postoperative opioid consumption
Time Frame: 12 HOURS
the total dose of pethidine required by the patient within the first 12 hours after surgery
12 HOURS
Pain Intensity using Visual Analogue Pain Scale (VAS)
Time Frame: 24-HOURS
Assessment of pain levels using the Visual Analogue Pain Scale every 2 hours for a total of 24 hours
24-HOURS
Hemodynamic stability
Time Frame: 24-HOURS
Monitoring for any adverse effects on heart rate
24-HOURS
Hemodynamic stability
Time Frame: 24-HOURS
Monitoring for any adverse effects on mean arterial blood pressure
24-HOURS
Postoperative complications
Time Frame: 24-HOURS
Monitoring for issues such as bleeding, hematoma, or local anesthetic toxicity over the first 24 hours
24-HOURS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ain Shams University

Investigators

  • Study Chair: Ashraf A Abouslemah, PhD, Ain Shams University
  • Study Director: Ahmed F Abdelraouf, PhD, Ain Shams University
  • Principal Investigator: Sameh A Hosny, MSc, Ain Shams University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Actual)

November 1, 2025

Study Completion (Actual)

November 25, 2025

Study Registration Dates

First Submitted

February 8, 2026

First Submitted That Met QC Criteria

February 14, 2026

First Posted (Actual)

February 18, 2026

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 14, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS 222/2025

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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