AzTrials
AzTrials

SpondylolisthesisNCT07514806

Ultrasound-Guided Erector Spinae Plane Block for Postoperative Pain Control in Lumbar Spondylolisthesis Surgery

A study testing Intervention Group: General Anesthesia With Ultrasound-Guided Erector Spinae Plane Block in people with Spondylolisthesis and Analgesia, Postoperative, run by Bangladesh Medical University at 1 site in Bangladesh.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This clinical trial aims to evaluate the effectiveness of ultrasound-guided erector spinae plane (ESP) block as an adjunct to general anesthesia for managing postoperative pain in patients undergoing lumbar spondylolisthesis surgery. Read more about this study

Who is it for?
Ages 18 to 64 years
Conditions the study is for
Spondylolisthesis, Analgesia, Postoperative, ESPB
What is being tested?
Intervention Group: General Anesthesia With Ultrasound-Guided Erector Spinae Plane Block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteBangladesh
Study dates
1 Jun 2024to 30 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patient undergoing lumbar spondylolisthesis surgery.
  • Elective procedures.
  • Age between 18 to 64 years.
  • American Society of Anaesthesiologists (ASA) physical status 1 and 2.

Who cannot join

  • Patient refusal.
  • Body Mass Index (BMI) >35 kg/m2
  • Coagulopathy or bleeding disorders.
  • Allergy to any of the study drugs.
  • Substance abuse or dependence or previous history of opioid addiction.
  • Patients with central nervous system disease, severe cardiovascular system disease, hepatic disease or renal disease.
  • Local infection or inflammation at the site of block placement.

Trial locations and contacts

1 site in 1 country.

Bangladesh1 site
  • Bangladesh Medical University

    Dhaka, 1000

Other trials in Bangladesh

About this study

Official title: Estimation of Intraoperative Anaesthetic Drug Requirement in General Anaesthesia With or Without Erector Spinae Plane Block in Lumbar Spondylolisthesis Surgery

This clinical trial aims to evaluate the effectiveness of ultrasound-guided erector spinae plane (ESP) block as an adjunct to general anesthesia for managing postoperative pain in patients undergoing lumbar spondylolisthesis surgery. The study will compare two groups: one receiving general anesthesia with ESP block (intervention group) and the other receiving general anesthesia alone (control group). The primary objective is to assess postoperative pain relief, opioid consumption, and hemodynamic stability. Secondary outcomes include adverse events and recovery quality. This trial will provide valuable insights into the efficacy of ESP block in improving recovery outcomes and reducing opioid use in spine surgery patients.

Read the detailed description

This study is designed as a quasi-experimental trial to investigate the efficacy of the ultrasound-guided erector spinae plane (ESP) block in combination with general anesthesia for postoperative pain management in patients undergoing lumbar spondylolisthesis surgery. This clinical trial will recruit 50 adult patients scheduled for elective lumbar spine surgery, who are assigned to either the intervention or control group.

Intervention Group (Group B): Patients will receive ultrasound-guided ESP block as an adjunct to standard general anesthesia.

Control Group (Group A): Patients will receive general anesthesia without the erector spinae plane (ESP) block.

The trial will evaluate pain control (measured by Visual Analogue Scale [VAS] scores), opioid consumption, and hemodynamic parameters (such as heart rate, blood pressure, and oxygen saturation). Additionally, postoperative recovery quality, the incidence of adverse events, and any potential complications associated with the erector spinae plane (ESP) block will be monitored and compared between groups.

This trial also aims to assess whether the use of the erector spinae plane (ESP) block can reduce opioid consumption, improve hemodynamic stability, and enhance recovery quality in the postoperative period.

The study will be conducted at Bangladesh Medical University (BMU), Dhaka, with all ethical considerations adhered to, and informed consent will be obtained from all participants before enrollment. Participants will be followed for 24 hours post-surgery, with monitoring at several time points to assess the primary and secondary outcomes.

The results of this study are expected to provide valuable insights into the effectiveness of the erector spinae plane (ESP block) in improving surgical outcomes, reducing opioid use, and enhancing recovery after lumbar spine surgery.

Being tested
Control Group: General Anesthesia Without Erector Spinae Plane Block, Intervention Group: General Anesthesia With Ultrasound-Guided Erector Spinae Plane Block
Keywords
anaesthetic drug requirement, lumber spondylolisthesis surgery, Erector Spinae Plane Block
Medical subject headings
Spondylolisthesis, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Control Group: General Anesthesia Without Erector Spinae Plane BlockProcedure or surgery

    Intervention Type: Drug - General Anesthesia Description: Patients will receive general anesthesia using standard anesthetic agents (e.g., propofol, fentanyl, and isoflurane) without the addition of a regional block. No erector spinae plane (ESP) block will be performed.

  • Intervention Group: General Anesthesia With Ultrasound-Guided Erector Spinae Plane BlockProcedure or surgery

    Description: Patients will receive general anesthesia in combination with an ultrasound-guided erector spinae plane (ESP) block. The ESP block will be performed at the L3-L5 vertebral level using a 22-gauge needle, with 20 mL of 0.25% bupivacaine and 5 mg dexamethasone administered bilaterally under sterile conditions.

Study groups in NCT07514806
Study groupRoleWhat they receive
Control Group: General Anesthesia Without Erector Spinae Plane BlockActive comparatorControl Group: General Anesthesia Without Erector Spinae Plane Block In this group, patients will receive standard general anesthesia without the addition of an ultrasound-guided erector spinae plane (ESP) block. This arm will serve as the comparison group to assess the impact of the ESP block on postoperative pain and recovery outcomes.
Receives: Procedure: Control Group: General Anesthesia Without Erector Spinae Plane Block
Intervention Group: General Anesthesia With Ultrasound-Guided Erector Spinae Plane BlockExperimentalIntervention Group: General Anaesthesia With Ultrasound-Guided Erector Spinae Plane (ESP) Block In this group, patients will receive general anaesthesia in combination with an ultrasound-guided erector spinae plane block. The aim is to evaluate whether adding the ESP block improves postoperative pain control, reduces opioid consumption, and enhances hemodynamic stability during and after lumbar spondylolisthesis surgery.
Receives: Procedure: Intervention Group: General Anesthesia With Ultrasound-Guided Erector Spinae Plane Block

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intraoperative Opioid Requirements (Fentanyl in micrograms)

    The total amount of opioid (fentanyl in microgram) administered during surgery. The goal is to evaluate the opioid consumption required to maintain adequate analgesia during the procedure.

    Measured: Throughout the duration of surgery.

  2. Intraoperative Inhalational Anaesthetic (Isoflurane in ml/hour) Agent Requirements

    Description: The total consumption of inhalational anesthetic agents (Isoflurane in ml/hour) during the surgical procedure. This measure will help assess the inhalational anaesthetic requirement between groups.

    Measured: Throughout the duration of surgery

  3. Intraoperative Muscle Relaxant (vecuronium in mg) Requirements

    The total dose of muscle relaxant (vecuronium, in mg) is administered to maintain muscle relaxation during surgery. This will be compared between the two groups.

    Measured: Throughout the duration of surgery

Secondary outcomes (4)
  1. Intraoperative heart rate (HR)

    Measured: Recorded at 15-minute intervals during the surgery

  2. Intraoperative Systolic Blood Pressure (mmHg)

    Measured: Recorded at 15-minute intervals during the surgery

  3. Intraoperative diastolic blood pressure (mmHg)

    Measured: Recorded at 15-minute intervals during the surgery

  4. Intraoperative Mean Arterial Pressure (mmHg)

    Measured: Recorded at 15-minute intervals during the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2026
  2. Study start1 Jun 2024
  3. Primary completion30 Nov 2024
  4. Study completion30 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07514806
Sponsor's protocol ID
4975
Status last verified
Apr 2026
First submitted
31 Mar 2026
Last updated
9 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhang S, Han X, Zhou D, Sun M, Cang J, Miao C, Liang C. The effects of erector spinae plane block on perioperative opioid consumption and rehabilitation in video assisted thoracic surgery. BMC Anesthesiol. 2021 Dec 10;21(1):313. doi: 10.1186/s12871-021-01536-x.

    PubMed 34893026
  • Yang HM, Choi YJ, Kwon HJ, O J, Cho TH, Kim SH. Comparison of injectate spread and nerve involvement between retrolaminar and erector spinae plane blocks in the thoracic region: a cadaveric study. Anaesthesia. 2018 Oct;73(10):1244-1250. doi: 10.1111/anae.14408. Epub 2018 Aug 16.

    PubMed 30113699
  • Wilson AA, Schmid AM, Pestana P Jr, Tubog TD. Erector Spinae Plane Block on Postoperative Pain and Opioid Consumption After Lumbar Spine Surgery: A Systematic Review and Meta-analysis of Randomized Controlled Trials. J Perianesth Nurs. 2024 Feb;39(1):122-131. doi: 10.1016/j.jopan.2023.06.003. Epub 2023 Sep 23.

    PubMed 37747377
  • Willard FH, Vleeming A, Schuenke MD, Danneels L, Schleip R. The thoracolumbar fascia: anatomy, function and clinical considerations. J Anat. 2012 Dec;221(6):507-36. doi: 10.1111/j.1469-7580.2012.01511.x. Epub 2012 May 27.

    PubMed 22630613
  • Ueshima H, Inagaki M, Toyone T, Otake H. Efficacy of the Erector Spinae Plane Block for Lumbar Spinal Surgery: A Retrospective Study. Asian Spine J. 2019 Apr;13(2):254-257. doi: 10.31616/asj.2018.0114. Epub 2018 Nov 15.

    PubMed 30424594
  • Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.

    PubMed 29913392
  • Tulgar S, Thomas DT, Deveci U. Erector spinae plane block provides sufficient surgical anesthesia for ileostomy closure in a high-risk patient. J Clin Anesth. 2018 Aug;48:2-3. doi: 10.1016/j.jclinane.2018.04.001. Epub 2018 Apr 11. No abstract available.

    PubMed 29655135
  • Tulgar S, Ahiskalioglu A, De Cassai A, Gurkan Y. Efficacy of bilateral erector spinae plane block in the management of pain: current insights. J Pain Res. 2019 Aug 27;12:2597-2613. doi: 10.2147/JPR.S182128. eCollection 2019.

    PubMed 31695476
  • Sullivan TR, Kanda P, Gagne S, Costache I. Harlequin Syndrome Associated with Erector Spinae Plane Block. Anesthesiology. 2019 Sep;131(3):665. doi: 10.1097/ALN.0000000000002733. No abstract available.

    PubMed 31021847
  • Soro Domingo M, Belda Nacher FJ, Aguilar Aguilar G, Ferrandis Comes R, Garcia-Raimundo M, Martinez Pons V. [Preoxygenation for anesthesia]. Rev Esp Anestesiol Reanim. 2004 Jun-Jul;51(6):322-7. Spanish.

    PubMed 15303533
  • Weinstein JN, Lurie JD, Tosteson TD, Hanscom B, Tosteson AN, Blood EA, Birkmeyer NJ, Hilibrand AS, Herkowitz H, Cammisa FP, Albert TJ, Emery SE, Lenke LG, Abdu WA, Longley M, Errico TJ, Hu SS. Surgical versus nonsurgical treatment for lumbar degenerative spondylolisthesis. N Engl J Med. 2007 May 31;356(22):2257-70. doi: 10.1056/NEJMoa070302.

    PubMed 17538085
  • Schwartz RH, Urits I, Viswanath O, Urman RD, Kaye AD, Eskander JP. Successful combination of thoracodorsal interfascial plane block and erector spinae pain block for peri-operative pain control after lumbar laminectomy. J Clin Anesth. 2020 Jun;62:109705. doi: 10.1016/j.jclinane.2020.109705. Epub 2020 Jan 11. No abstract available.

    PubMed 31935574
  • Sachdev D, Mamikunian G, Kia C, Zhou H. Narrative review: erector spinae block in spine surgery. J Spine Surg. 2023 Dec 25;9(4):454-462. doi: 10.21037/jss-23-14. Epub 2023 Dec 20.

    PubMed 38196733
  • Rizkalla JM, Holderread B, Awad M, Botros A, Syed IY. The erector spinae plane block for analgesia after lumbar spine surgery: A systematic review. J Orthop. 2021 Feb 18;24:145-150. doi: 10.1016/j.jor.2021.02.006. eCollection 2021 Mar-Apr.

    PubMed 33716419
  • Peker K, Akcaboy ZN, Aydin G, Gencay I, Sahin AT, Kocak YF, Peker SA. The Effect of Erector Spinae Plane Block on Laparoscopic Cholecystectomy Anesthesia: Analysis of Opioid Consumption, Sevoflurane Consumption, and Cost. J Laparoendosc Adv Surg Tech A. 2020 Jul;30(7):725-729. doi: 10.1089/lap.2019.0809. Epub 2020 Feb 5.

    PubMed 32023174

Questions about this trial

What is this clinical trial studying?

A study testing Intervention Group: General Anesthesia With Ultrasound-Guided Erector Spinae Plane Block in people with Spondylolisthesis and Analgesia, Postoperative, run by Bangladesh Medical University at 1 site in Bangladesh.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intraoperative Opioid Requirements (Fentanyl in micrograms) (time frame: Throughout the duration of surgery.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07514806, which also lists 52 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in