Evaluation of the Effect of Adding Sodium Bicarbonate to Lidocaine in the Treatment of Myofascial Pain Syndrome

NCT07572994 | Not Yet Recruiting

• 1 other identifier: 3-3-3
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to evaluate a method to improve the treatment of myofascial pain syndrome (MPS), a common condition that causes muscle pain, tenderness, and reduced movement due to the presence of trigger points in muscles. A commonly used treatment for this condition is the injection of a local anesthetic called lidocaine into these trigger points to relieve pain. However, the pain relief from lidocaine alone may be temporary. In this study, we are investigating whether adding a small amount of sodium bicarbonate to lidocaine can improve its effectiveness. Sodium bicarbonate may reduce the pain during injection and help the anesthetic work faster and possibly last longer. Participants in this study will be randomly assigned into one of two groups: One group will receive lidocaine alone. The other group will receive lidocaine mixed with sodium bicarbonate. The injection will be performed once into the painful muscle trigger points under sterile conditions. Pain levels will be assessed using a simple pain scale, and muscle activity will be measured using a non-invasive technique called surface electromyography (sEMG), which records muscle electrical activity. These measurements will be taken before the injection, immediately after, and during follow-up visits. Participants may experience mild discomfort during or after the injection, but all procedures are routinely used in clinical practice. Safety measures will be in place to manage any possible side effects. The goal of this study is to determine whether the combined injection provides better pain relief, improves muscle function, and enhances patient comfort compared to lidocaine alone.

Conditions

Myofacial Pain; Myofacial Pain Syndrome; Myofacial Pain Syndromes; Trigger Point Pain, Myofascial; Myofascial Pain Dysfunction Syndrome

Keywords

lidocaine; Sodium Bicarbonate; Buffered Lidocaine; Trigger Point Injection; Surface Electromyography; Myofascial Trigger Points; Muscle Pain; Injection Pain; Muscle Activity; Musculoskeletal Pain

Outcome Measures

Primary Outcomes (1)

• Reduction in Pain Intensity

  Pain intensity will be assessed using the Visual Analog Scale (VAS) (0-10). In addition, surface electromyography (sEMG) will be used to objectively evaluate muscle activity at rest (MVC%). A reduction in VAS scores and sEMG activity indicates improvement.

  Baseline, immediately after injection, and 2 weeks post-injection

Secondary Outcomes (1)

• Pain During Injection

  Immediately after injection

Other Outcomes (1)

• Change in Muscle Activation Pattern

  Baseline and 2 weeks post-injection

Study Arms (2)

Lidocaine 2% (control group)

ACTIVE COMPARATOR

Participants in this group will receive a single-session trigger point injection using 2% lidocaine without any additives. The injection will be administered into the identified myofascial trigger points using a standardized technique under aseptic conditions.

Drug: Lidocaine 2 %

Lidocaine + Sodium Bicarbonate (buffered group)

EXPERIMENTAL

Participants in this group will receive a single-session trigger point injection using 2% lidocaine combined with sodium bicarbonate. The buffered solution is intended to reduce injection pain and enhance anesthetic effectiveness.

Drug: Lidocaine + Sodium Bicarbonate

Interventions

Lidocaine 2 % DRUG

2% lidocaine (preservative-free, without vasoconstrictor) will be administered via intramuscular injection into the identified trigger points. Approximately 1.8 mL will be injected per point using a sterile 25-27 gauge needle. The injection will be performed using a standardized "fast-in, fast-out" (peppering) technique.

Lidocaine 2% (control group)

Lidocaine + Sodium Bicarbonate DRUG

A buffered anesthetic solution will be prepared immediately before injection by mixing 2% lidocaine with 8.4% sodium bicarbonate in a ratio of 9:1 (1.8 mL lidocaine + 0.2 mL sodium bicarbonate per injection point). The solution will be administered via intramuscular injection into trigger points using a sterile 25-27 gauge needle and standardized injection technique.

Lidocaine + Sodium Bicarbonate (buffered group)

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 16 to 70 years Clinical diagnosis of myofascial pain syndrome (MPS) Presence of active myofascial trigger points Pain duration ≥ 3 months Pain intensity ≥ 4 on the Visual Analog Scale (VAS) Trigger points located in accessible muscles No trigger point injection in the affected area within the past 3 months Ability and willingness to provide informed consent Willingness to comply with study procedures and follow-up visits

You may not qualify if:

• Known allergy or hypersensitivity to lidocaine, sodium bicarbonate, or other amide-type local anesthetics Current use of anticoagulants or presence of bleeding disorders Local or systemic infection at or near the injection site History of fibromyalgia, cancer-related pain, or central pain syndromes Major psychiatric disorders (e.g., schizophrenia, severe depression) Recent trauma or surgery to the neck, shoulder, or back within the past 6 months Use of analgesics (e.g., NSAIDs, opioids) within 5 days prior to injection Severe systemic diseases (e.g., uncontrolled diabetes, liver failure, kidney failure, severe cardiovascular disease)

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry Cairo University

Cairo, Cairo Governorate, 22023, Egypt

Location

Related Publications (4)

• Curatolo M, Petersen-Felix S, Arendt-Nielsen L, Lauber R, Hogstrom H, Scaramozzino P, Luginbuhl M, Sieber TJ, Zbinden AM. Adding sodium bicarbonate to lidocaine enhances the depth of epidural blockade. Anesth Analg. 1998 Feb;86(2):341-7. doi: 10.1097/00000539-199802000-00024.

  PMID: 9459246 BACKGROUND

• McKay W, Morris R, Mushlin P. Sodium bicarbonate attenuates pain on skin infiltration with lidocaine, with or without epinephrine. Anesth Analg. 1987 Jun;66(6):572-4. No abstract available.

  PMID: 3034106 BACKGROUND

• Burns CA, Ferris G, Feng C, Cooper JZ, Brown MD. Decreasing the pain of local anesthesia: a prospective, double-blind comparison of buffered, premixed 1% lidocaine with epinephrine versus 1% lidocaine freshly mixed with epinephrine. J Am Acad Dermatol. 2006 Jan;54(1):128-31. doi: 10.1016/j.jaad.2005.06.043.

  PMID: 16384767 BACKGROUND

• Ghasemi M, Mosaffa F, Hoseini B, Behnaz F. Comparison of the Effect of Bicarbonate, Hyaluronidase, and Lidocaine Injection on Myofascial Pain Syndrome. Anesth Pain Med. 2020 Jun 23;10(3):e101037. doi: 10.5812/aapm.101037. eCollection 2020 Jun.

  PMID: 32944559 BACKGROUND

MeSH Terms

Conditions

Facial Pain; Facial Neuralgia; Myofascial Pain Syndromes; Fibromyalgia; Myalgia; Musculoskeletal Pain

Interventions

Lidocaine; Sodium Bicarbonate

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Facial Nerve Diseases; Mouth Diseases; Stomatognathic Diseases; Cranial Nerve Diseases; Nervous System Diseases; Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Bicarbonates; Carbonates; Carbonic Acid; Carbon Compounds, Inorganic; Inorganic Chemicals; Sodium Compounds

Study Officials

• Khalid elhayes, professor

  cairo university oral and maxillofacial surgery department

  STUDY CHAIR

• Abdelmoez Mohamed El-Sharkawy, Associate professor

  cairo University -oral and maxillofacial surgery department

  STUDY DIRECTOR

• Adham Yehia Zakaria, Lecturer

  cairo university oral and maxillofacial surgery department

  STUDY DIRECTOR

• Eman hassan Elzamarany, lecturer

  Department of Neurology and Clinical Physiology Faculty of Medicine, Cairo University

  STUDY DIRECTOR

• ola mohamed Abdelfath

  cairo university oral and maxillofacial surgery department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ola mohamed Abdelfatah, bachelor

CONTACT

+201122789240; ola.abdelfatah@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This is a single-blind study in which participants are unaware of their group allocation. The operator administering the injection and the outcome assessor are not blinded due to the nature of the intervention and preparation of the buffered solution. Participants are not informed whether they receive lidocaine alone or lidocaine combined with sodium bicarbonate.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: "Postgraduate Researcher (Master's Candidate), Oral and Maxillofacial Surgery, Faculty of Dentistry, Cairo University"

Model Details: Participants will be randomly assigned in a 1:1 ratio into two parallel groups: one group receiving trigger point injection with 2% lidocaine alone (control), and the other receiving 2% lidocaine buffered with sodium bicarbonate (intervention). Each participant will receive a single-session injection and will remain in the assigned group throughout the study. Outcomes will be assessed at baseline, immediately post-injection, and at follow-up visits.

Study Record Dates

• First Submitted: April 30, 2026
• First Posted: May 7, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)