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

NCT07418671 | Completed Phase 2

• 1 other identifier: MS 222/2025
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Post-operative analgesia duration

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

  24-HOURS

Secondary Outcomes (5)

• Total postoperative opioid consumption

  12 HOURS

• Pain Intensity using Visual Analogue Pain Scale (VAS)

  24-HOURS

• Hemodynamic stability

  24-HOURS

• Hemodynamic stability

  24-HOURS

• Postoperative complications

  24-HOURS

Study Arms (3)

Group BS (Bupivacaine-Saline): control

ACTIVE COMPARATOR

Group BS: The group will receive 30 ml 0.25% bupivacaine plus 5 ml normal saline.

Combination Product: Bupivacaine-Saline

Group BM (Bupivacaine-Magnesium)

ACTIVE COMPARATOR

the group will receive 30 mL 0.25% bupivacaine plus 5ml of 10% MgSO4

Combination Product: Bupivacaine-Magnesium Sulphate

Group BD (Bupivacaine-Dexamethasone)

ACTIVE COMPARATOR

The group will receive 30 mL 0.25% bupivacaine plus 5 ml normal saline containing 8 mg dexamethasone.

Combination Product: Bupivacaine-Dexamethasone

Interventions

Bupivacaine-Magnesium Sulphate COMBINATION_PRODUCT

Bupivacaine plus Magnesium Sulphate (MgSO4) as adjuvant

Group BM (Bupivacaine-Magnesium)

Bupivacaine-Dexamethasone COMBINATION_PRODUCT

Bupivacaine plus Dexamethasone as adjuvant

Group BD (Bupivacaine-Dexamethasone)

Bupivacaine-Saline COMBINATION_PRODUCT

Bupivacaine plus Saline as control

Group BS (Bupivacaine-Saline): control

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Cairo Governorate, 1181, Egypt

Location

Related Publications (24)

• Farahata TEM, El-Bahnasawy NS, Heikal O, El-Mohaimen A. Efficacy of adding dexamethasone to levobupivacaine in erector spinae block for total hip arthroplasty. Egypt J Hosp Med. 2022;87(1):2184-2189.

  RESULT

• Reysner T, Kowalski G, Resyner M, Geisler-Wojciechowska A, Grochowicka M, et al. Erector spinae plane block for pain management after total hip arthroplasty: a systematic review and meta-analysis. Chir Narzadow Ruchu Ortop Pol. 2024;89(4):170-177.

  RESULT

• Tulgar S, Kose HC, Selvi O, Senturk O, Thomas DT, Ermis MN, Ozer Z. Comparison of ultrasound-guided lumbar erector spinae plane block and transmuscular quadratus lumborum block for postoperative analgesia in hip and proximal femur surgery: a prospective randomized feasibility study. Anesth Essays Res. 2018;12(4):825-831.

  RESULT

• Hines K, Davis E, O'Shea K, Vogl K. Rehabilitation after total hip arthroplasty. In: Essentials in Total Hip Arthroplasty. Boca Raton (FL): CRC Press; 2024. p. 269-275.

  RESULT

• Ahmed Mostafa Aref F, Abdelaziz NM, Elazazzi HM, Fahmy NG. Effect of addition of magnesium sulfate and dexamethasone versus plain bupivacaine in ultrasound-guided erector spinae plane block in pediatrics undergoing repair of inguinal hernia. Egypt J Anaesth. 2023;39(1):906-911.

  RESULT

• Abd El Rahman A, Mohamed M, Hassan A, Mohammed H. Comparative study between dexamethasone-bupivacaine versus magnesium sulfate-bupivacaine for postoperative analgesia. Sohag Med J. 2017;21(3):589-595.

  RESULT

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• Ratnaparkhi R, Javellana M, Jewell A, Spoozak L. Evaluation of Homologous Recombination Deficiency in Ovarian Cancer. Curr Treat Options Oncol. 2024 Feb;25(2):237-260. doi: 10.1007/s11864-024-01176-6. Epub 2024 Feb 1.

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• Zhang Y, Dong C, Zheng C, Lv Z, Tian RN, Wang M, Chen J, Wang D, Zhang X, Mao Z. Soft-in-Rigid Strategy Promoting Rapid and High-Capacity Lithium Storage by Chemical Scissoring. Inorg Chem. 2024 Jun 17;63(24):11406-11415. doi: 10.1021/acs.inorgchem.4c01493. Epub 2024 Jun 4.

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• Miele E, Abballe L, Spinelli GP, Besharat ZM, Catanzaro G, Chiacchiarini M, Vacca A, Po A, Capalbo C, Ferretti E. BRAF mutant colorectal cancer: ErbB2 expression levels as predictive factor for the response to combined BRAF/ErbB inhibitors. BMC Cancer. 2020 Feb 17;20(1):129. doi: 10.1186/s12885-020-6586-0.

  PMID: 32066410 RESULT

• Chan A, Ng TKT, Tang BYH. Single-Shot Lumbar Erector Spinae Plane Block in Total Hip Replacement: A Randomized Clinical Trial. Anesth Analg. 2022 Oct 1;135(4):829-836. doi: 10.1213/ANE.0000000000006162. Epub 2022 Aug 1.

  PMID: 35913722 RESULT

• Chin KJ, El-Boghdadly K. Mechanisms of action of the erector spinae plane (ESP) block: a narrative review. Can J Anaesth. 2021 Mar;68(3):387-408. doi: 10.1007/s12630-020-01875-2. Epub 2021 Jan 6.

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• Shambhavi T, Das S, Senapati LK, Padhi PP. Comparative evaluation of bupivacaine with magnesium sulphate and dexamethasone as adjuvants in ultrasound-guided transversus abdominis plane block for open unilateral inguinal hernia surgeries: A randomised controlled trial. Indian J Anaesth. 2023 Apr;67(4):370-375. doi: 10.4103/ija.ija_1091_21. Epub 2023 Apr 10.

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MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Ashraf A Abouslemah, PhD

  Ain Shams University

  STUDY CHAIR

• Ahmed F Abdelraouf, PhD

  Ain Shams University

  STUDY DIRECTOR

• Sameh A Hosny, MSc

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2026
• First Posted: February 18, 2026
• Study Start: May 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: November 25, 2025
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

EG (1)