Ultrasound vs. Surgical ESP Block With Bupivacaine-Dexmedetomidine in Lumbar Fusion Surgery

November 14, 2025 updated by: Mohamed Ahmed Hamed, Fayoum University Hospital

Efficacy of Ultrasound-guided Versus Surgical Erector Spinae Plane Block With a Mixture of Bupivacaine and Dexmedetomidine in Lumbar Spinal Fusion Surgery: A Prospective Randomized Double-Blinded Clinical Trial.

Lumbar spine surgery causes intense post-op pain, peaking within 12 hours and improving by day three. Traditional spinal procedures involve extensive tissue dissection, leading to severe pain and potential complications like delayed mobilization, respiratory issues, and chronic pain. Effective pain management is crucial. Opioid-based relief is standard but comes with side effects (nausea, respiratory depression), increasing hospital stays and costs.

Dexmedetomidine (DEX) is an alpha-2 adrenergic receptor agonist that enhances nerve block duration when combined with local anesthetics (LAs). It works by inhibiting sodium and potassium channels, leading to prolonged hyperpolarization.

Regional nerve blocks, such as thoracic epidurals and fascial plane blocks, improve postoperative pain management and help reduce opioid use, minimizing complications. Various techniques, including ESP blocks, paravertebral Block (PVB), and Serratus anterior Block (SAB) have been explored for acute pain relief.

The Erector Spinae Plane Block (ESPB), initially used for thoracic neuropathic pain, has expanded to thoracic, breast, and abdominal surgeries.

The ESP block is done by injecting a local anesthetic between the transverse process and the erector spinae muscle. Ultrasound guidance helps visualize the spread of the anesthetic and the surrounding anatomy. Previous studies indicate that the ESP block can effectively relieve pain after lumbar spine surgery and may reduce postoperative opioid use when local anesthetics are applied to the wound and deep tissues. Based on this, performing the ESP block directly by the surgical team, using a local anesthetic between the erector spinae muscle and transverse process with direct view and free hand, may yield similar results to the ultrasound guided technique. The current study aims to evaluate the analgesic efficacy of Ultrasound-Guided Erector Spinae Plane Block in comparison with surgical Erector Spinae Plane Block using a mixture of bupivacaine and dexmedetomidine in lumbar Spinal fusion Surgeries.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After approval of the local institutional ethics committee and local institutional review board. Patients scheduled for elective lumbar spinal Fusion surgeries and fulfilling the inclusion criteria in Fayoum University Hospital starting from February 2025 will be enrolled in this prospective randomized study until fulfilling the sample size. The eligible participants will sign a detailed informed consent before recruitment.

Randomization will be done using computer-generated random numbers placed in separate opaque envelopes and opened by the anesthesiologist just before induction of anesthesia, eligible patients will be randomized with 1:1 allocation ratio into two groups:

  • The surgical ESPB group (SB)
  • The Ultrasound guided ESPB group (UB) Both the anesthesiologist and the surgeons performing the US guided ESP block and surgical ESP block will not be further involved in the study. Another anesthesiologist will be responsible for further patient care and data collection. This anesthesiologist and the patient will be blinded from the group assignments.

General anesthesia:

Upon arrival at the operating theatre, all patients will be monitored using electrocardiography, pulse-oximetry, capnography, and Noninvasive blood pressure (NIBP). After routine history, examination, and review of laboratory results, General anesthesia will be induced with intravenous propofol (2 mg/kg), fentanyl (1 μg/kg), and atracurium (0.5mg/kg). After that, patients will be intubated and placed in a prone position. Anesthesia will be maintained using IV atracurium and inhalational anesthesia (isoflurane) in an oxygen and fresh air mixture. All patients will receive intravenous Ketorolac (30 mg), Nalbuphine (10 mg), and Ondansetron 8 mg approximately 30 min before the end of the surgery.

Block technique:

For patients in Group UB, an ultrasound-guided ESP block will be performed after the surgical incision is closed and before extubation, while the patient remains in the prone position. A linear high-frequency transducer (L6-12 linear array transducer (6-12 MHz) on GE Healthcare logiq p7, made in Korea) will be positioned in a sagittal orientation, 4 cm lateral to the L3 transverse process. A 22 G × 88 mm block needle will be inserted in the craniocaudal direction, with the needle tip placed beneath the erector spinae muscle and above the hyperechoic transverse process. The needle tip position will be confirmed via saline injection. Once correct needle placement is verified, 40 mL of 0.25% bupivacaine, combined with 0.5 μg/kg dexmedetomidine 15 will be administered divided on both sides. For patients in group SB, the injectate will be prepared with the help of the anesthetist by adding 0.5 μg/kg dexmedetomidine to 40 mL of 0.25% bupivacaine. This volume will be divided into 8 injections, four 5 ml injections on each side. The surgeons will perform the block just before starting the wound closure stage. The surgical ESP block technique consists of injections at four bilateral levels, starting from one level above the operated vertebra and covering all surgical segments using a 22G × 88 mm needle. The needle will be inserted to contact the transverse process, and the injectate will be delivered between the erector spinae muscle and the transverse process at each level.

Postoperative pain management:

After discharge to ward, all patients will receive paracetamol 1g / 8hrs, ketorolac 30 mg/ 12hrs and nalbuphine 5mg as a rescue analgesia. The patient's pain will be evaluated using a Visual Analog Scale (VAS) where 0 denotes no pain, and 10 represents the most intense pain ever experienced. Dynamic and static VAS scores will be recorded in the postoperative period at 1, 4, 8, 16, 24, 36 and 48 hours. Patients with VAS scores of 4 or higher will receive Nalbuphine (5 mg) for rescue analgesia.

sample size calculation and statistical analysis : Sample size was calculated using IBM SPSS 29 software for windows (IBM Co., Armonk, NY, USA). Calculation of the sample size was based on the ability to detect a difference of one point in the VAS score between the two groups based on the results of a study by Kaciroglu, A. et al. At least 23 patients are needed per group to detect this difference at α level of 0.05 and study power of 80%. We decided to recruit 26 patients per group to compensate for any possible withdrawals up to 10% and to increase the study power. The sample size calculation was based on the independent samples t test. Statistical analysis will be performed using SPSS for Windows, version 29 (IBM Corp., and Armonk, New York, USA). Descriptive statistics will be presented in the form of (mean ± SD), or (median with interquartile range) for numerical data, while numbers and percentages will be used for categorical data. Testing for normality of distribution will be done using the Shapiro-Wilk test. Categorical variables will be analyzed using Chi-square test or Fisher's exact test. Differences in parametric normally distributed numerical data will be compared using Student's t tests, While the non-parametric data will be compared using Mann Whitney U-test. Results will be considered statistically significant if the p value is less than 0.05.

Study Type

Interventional

Enrollment (Actual)

52

Phase

  • Phase 4

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
    • Fayoum Governorate
      • Al Fayyum, Fayoum Governorate, Egypt, 63514
        • Fayoum University hospital

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:

- American Society of Anesthesiologists (ASA) I-Ⅲ patients scheduled for elective two or three levels of lumbar spinal fusion surgeries by the same surgical team.

Exclusion Criteria:

  • Patient refusal.
  • Body mass index > 30 kg/m2
  • Significant renal, hepatic, or cardiovascular diseases.
  • History of allergy to one of the study drugs (local anesthetics, opioids, or dexmedetomidine).
  • Any contraindications to regional anesthesia like local infection or abnormal coagulation function.
  • Pregnant or breastfeeding women.
  • Chronic opioid use, history of chronic pain, or cognitive disorders.
  • Emergent surgeries.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ultrasound Guided erector spinae plane block (UB)
the block will be done using ultrasound device after wound closure
Procedure: Ultrasound Guided erector spinae plane block (UB)
Ultrasound Guided erector spinae plane block (UB) with 40 ml Bupivacaine HCL mixed with 0.5 μg/kg dexmedetomidine .. After the surgical incision is closed and before extubation, while the patient remains in the prone position. A linear high-frequency transducer (L6-12 linear array transducer (6-12 MHz) on GE Healthcare logiq p7, made in Korea) will be positioned in a sagittal orientation, 4 cm lateral to the L3 transverse process. A 22 G × 88 mm block needle will be inserted in the craniocaudal direction, with the needle tip placed beneath the erector spinae muscle and above the hyperechoic transverse process. The needle tip position will be confirmed via saline injection. Once correct needle placement is verified, 40 mL of 0.25% bupivacaine, combined with 0.5 μg/kg dexmedetomidine 15 will be administered divided on both sides.
Drug: Dexmedetomidine
0.5 μg/kg dexmedetomidine added to block solution
Other Names:
  • precedex
Drug: Bupivacaine Hcl 0.5% Inj
40 ml Bupivacaine HCL
Other Names:
  • Marcaine
Active Comparator: Surgical erector spinae plane block (SB)
the block will be done surgically before wound closure
Drug: Dexmedetomidine
0.5 μg/kg dexmedetomidine added to block solution
Other Names:
  • precedex
Drug: Bupivacaine Hcl 0.5% Inj
40 ml Bupivacaine HCL
Other Names:
  • Marcaine
Procedure: Surgical erector spinae plane block (SB)
Surgical erector spinae plane block (SB) with 40 ml Bupivacaine HCL mixed with 0.5 μg/kg dexmedetomidine ..This volume will be divided into 8 injections, four 5 ml injections on each side. The surgeons will perform the block just before starting the wound closure stage. The surgical ESP block technique consists of injections at four bilateral levels, starting from one level above the operated vertebra and covering all surgical segments using a 22G × 88 mm needle. The needle will be inserted to contact the transverse process, and the injectate will be delivered between the erector spinae muscle and the transverse process at each level.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
QAQStatic VAS score one hour postoperatively.
Time Frame: one hour after surgery
Visual Analog Scale (VAS) tool used to measure pain of patients after surgery, consist of 100mm length scale where 0 = "no pain" and 100 = "worst imaginable pain". static VAS score to be obtained one hour after surgery.
one hour after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative static VAS scores.
Time Frame: At 48 hours after the block
Visual Analog Scale (VAS) tool used to measure pain of patients after surgery, consist of 100mm length scale where 0 = "no pain" and 100 = "worst imaginable pain". static VAS score to be obtained at 2, 4, 8, 16, 24, 36, and 48 hours after the block.
At 48 hours after the block
Postoperative dynamic VAS scores.
Time Frame: At 48 hours after the block
Visual Analog Scale (VAS) tool used to measure pain of patients after surgery, consist of 100mm length scale where 0 = "no pain" and 100 = "worst imaginable pain". Dynamic VAS score to be obtained at 2, 4, 8, 16, 24, 36, and 48 hours after the block.
At 48 hours after the block
Time consumed in the block.
Time Frame: the time After starting blocking procedure till finishing procedure up to 1 hour
Time of the block procedure
the time After starting blocking procedure till finishing procedure up to 1 hour
The time of the first postoperative analgesic request.
Time Frame: the time After blocking procedure till the first request of analgesia up to 48 hours
The time consumed after block until first request of analgesia.
the time After blocking procedure till the first request of analgesia up to 48 hours
Total postoperative needs of nalbuphine.
Time Frame: At first 24 hours after ESP block.
amount of nalbuphine used in milligrams.
At first 24 hours after ESP block.
Heart rate (HR)
Time Frame: Assessed up to 48 hours after block.
at 0 (block time), 5min, 10 min, 15 min, 30 min, 1h, 2h, 4h, 8h, 16h, 24h, 36h, and 48h after ESP block.
Assessed up to 48 hours after block.
Mean Arterial Pressure (MAP)
Time Frame: Assessed up to 48 hours after block.
at 0 (block time), 5min, 10 min, 15 min, 30 min, 1h, 2h, 4h, 8h, 16h, 24h, 36h, and 48h after ESP block.
Assessed up to 48 hours after block.
number of participants with nausea and vomiting.
Time Frame: Assessed up to 48 hours after block.
Complications related to the block or study medications.
Assessed up to 48 hours after block.
Incidence of respiratory depression
Time Frame: At first 24 hours after ESP block.
Respiratory Rate < 8 bpm.
At first 24 hours after ESP block.
number of participants with pruritus
Time Frame: At first 24 hours after ESP block.
Complications related to the block or study medications
At first 24 hours after ESP block.
number of participants with manifestations of systemic toxicity from local anesthetic drugs
Time Frame: At first 24 hours after ESP block.
Assess for neurological or cardiovascular toxicity symptoms
At first 24 hours after ESP block.
Sedation level
Time Frame: Assessed up to 24 hours after block.

Assess sedation level, using a four-point sedation scale (score 1 = spontaneous eye opening [awake and alert]; score 2 = drowsy, responsive to verbal stimuli.

score 3 = drowsy, arousable to physical stimuli; score 4 = unresponsive) ِِAssessed at 1, 2, 4, 8, 16, 24 hours after the block
Assessed up to 24 hours after block.
24h Quality of recovery questionnaire (QoR-15)
Time Frame: 24 hours after surgery.
15 items questionnaire used to evaluate the quality of recovery 24h after surgery, an aggregate score from 0 (no recovery) to 150 (total recovery)
24 hours after surgery.
Length of hospital stay
Time Frame: The Time of stay (surgery day) until hospital discharge up to 7 days
measured in days, from day 0, the day of surgery, until discharge
The Time of stay (surgery day) until hospital discharge up to 7 days

Collaborators and Investigators

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

Sponsor

Fayoum University Hospital

Investigators

  • Principal Investigator: Mohamed A Hamed, MD, Fayoum University hospital
  • Study Director: Mohamed A Elsaeed, MD, Fayoum University hospital

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 6, 2025

Primary Completion (Actual)

August 31, 2025

Study Completion (Actual)

August 31, 2025

Study Registration Dates

First Submitted

April 21, 2025

First Submitted That Met QC Criteria

April 26, 2025

First Posted (Actual)

May 6, 2025

Study Record Updates

Last Update Posted (Actual)

November 17, 2025

Last Update Submitted That Met QC Criteria

November 14, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M762

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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