Evaluation of Ultrasound Assisted Localisation of the Intervertebral Space Versus the Traditional Landmark Technique During Subarachnoid Block for Caesarean Section in Obese Parturient
Sponsor study identifier
interventional
60
1 country
1
Study Start
February 1, 2025
Actual (reported)Primary Completion
August 30, 2025
Actual (reported)Study Completion
November 30, 2025
Actual (reported)The goal of this clinical trial is to evaluate whether the ultrasound-assisted technique improves the accuracy and safety of spinal anesthesia compared to the traditional landmark technique in obese women undergoing a cesarean section. The main questions it aims to answer are: Does the ultrasound-assisted technique reduce the number of needle attempts required for successful spinal anesthesia? Does the ultrasound-assisted technique decrease the incidence of post-dural puncture headache (PDPH) and chronic low back pain at the needle insertion site? Does the ultrasound-assisted technique reduce procedure time compared to the landmark technique? Participants will: Receive spinal anesthesia using either the ultrasound-assisted technique or the traditional landmark technique for cesarean section. Be monitored for the number of needle attempts, procedure time, and any post-operative complications such as PDPH or low back pain. Follow up for three months after the procedure to assess any long-term effects, including chronic low back pain and quality of life.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 30, 2025
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 1, 2025
Actual (reported)August 30, 2025
Actual (reported)November 30, 2025
Actual (reported)May 8, 2026
Actual (reported)May 22, 2026
Actual (reported)Number of Needle Attempts for Successful Subarachnoid Block
his is the key measure in your study, as it directly assesses the effectiveness of the two anesthesia techniques (ultrasound-assisted vs. landmark-guided) in achieving successful spinal anesthesia. Fewer needle attempts would indicate a higher success rate and a more efficient technique, making it the most critical outcome for evaluating the interventions.
During the procedure, until successful spinal needle placement
Needle Insertion Site Accuracy in landmark technique group
Immediately after transferring the participants in the recovery room
Procedure Duration in minutes
During procedure
Incidence of Post-Dural Puncture Headache (PDPH)
Postoperative period (up to 72 hours)
Chronic Low Back Pain at Needle Insertion Site
3 months post-procedure
Impact of Chronic Low Back Pain on Quality of Life
3 months post-procedure
In this arm, participants will receive subarachnoid block using the traditional landmark technique for spinal anesthesia. The L3-L4 or L4-L5 intervertebral space will be identified by palpating the iliac crests to locate Tuffier's line, and the spinal needle will be inserted based on these bony landmarks. The anesthetic agents administered will be 0.5% hyperbaric bupivacaine (10 mg) and 25 μg fentanyl (0.5 mL). The procedure will be performed by experienced anesthesiologists.
In this arm, participants will receive subarachnoid block using the ultrasound-assisted technique. A low-frequency (2-5 MHz) curvilinear probe will be used to visualize the lumbar spine and identify the intervertebral space. The correct intervertebral space (L3-L4 or L4-L5) will be identified using real-time ultrasound imaging. The anesthetic agents administered will be 0.5% hyperbaric bupivacaine (10 mg) and 25 μg fentanyl (0.5 mL). This procedure will also be performed by experienced anesthesiologists with expertise in neuraxial ultrasound.
This intervention involves the use of traditional anatomical landmarks to locate the correct intervertebral space for performing subarachnoid block (SAB). The anesthesiologist identifies the L3-L4 or L4-L5 intervertebral space by palpating the iliac crests and using Tuffier's line as a reference. A 25G Quincke needle is used for SAB, and 0.5% hyperbaric bupivacaine with 25 μg fentanyl is administered. This technique is the standard approach used in many clinical settings for spinal anesthesia.
Bangladesh Medical University
Dhaka, 1000, Bangladesh
Wattanaruangkowit P, Lakchayapakorn K. The position of the lumbar vertebrae in relation to the intercrestal line. J Med Assoc Thai. 2010 Nov;93(11):1294-300.
Srinivasan KK, Leo AM, Iohom G, Loughnane F, Lee PJ. Pre-procedure ultrasound-guided paramedian spinal anaesthesia at L5-S1: Is this better than landmark-guided midline approach? A randomised controlled trial. Indian J Anaesth. 2018 Jan;62(1):53-60. doi: 10.4103/ija.IJA_448_17.
AKM Akhtaruzzaman, MD
Bangladesh Medical University
60 participants (actual enrollment reported by the registry).
First Submitted
May 8, 2026
First Posted
May 22, 2026
Study Start
February 1, 2025
Actual (reported)Comparison of Modified Perichondral Approach Thoracoabdominal Nerve Block and Transversus Abdominal Plane Block in Analgesia Management Following Caesarean Section Surgery
This intervention utilizes ultrasound guidance to identify the correct intervertebral space for performing subarachnoid block (SAB). A low-frequency (2-5 MHz) curvilinear ultrasound probe is used to visualize the lumbar spine in real-time, ensuring precise identification of the L3-L4 or L4-L5 intervertebral space. The anesthesiologist places the needle based on ultrasound images that show the anatomical structures, such as the spinous processes and interlaminar spaces. The same anesthetic agents (0.5% hyperbaric bupivacaine and 25 μg fentanyl) are administered through a 25G Quincke needle for SAB.
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Sahin T, Balaban O, Sahin L, Solak M, Toker K. A randomized controlled trial of preinsertion ultrasound guidance for spinal anaesthesia in pregnancy: outcomes among obese and lean parturients: ultrasound for spinal anesthesia in pregnancy. J Anesth. 2014 Jun;28(3):413-9. doi: 10.1007/s00540-013-1726-1. Epub 2013 Oct 20.
Kurdi MS, Agrawal P, Thakkar P, Arora D, Barde SM, Eswaran K. Recent advancements in regional anaesthesia. Indian J Anaesth. 2023 Jan;67(1):63-70. doi: 10.4103/ija.ija_1021_22. Epub 2023 Jan 21.
Khan MA, Gupta M, Sharma S, Kasaudhan S. A comparative study of ultrasound assisted versus landmark technique for combined spinal-epidural anaesthesia in patients undergoing lower limb orthopaedic surgery. Indian J Anaesth. 2022 Apr;66(4):272-277. doi: 10.4103/ija.ija_775_21. Epub 2022 Apr 20.
Gayathri B, Swetha Ramani CK, Urkavalan K, Pushparani A, Rajendran A. Comparison of the time taken for subarachnoid block using ultrasound-guided method versus landmark technique for cesarean section - A randomized controlled study. J Anaesthesiol Clin Pharmacol. 2021 Apr-Jun;37(2):205-209. doi: 10.4103/joacp.JOACP_35_20. Epub 2021 Jul 15.
Forozeshfard M, Jahan E, Amirsadat J, Ghorbani R. Incidence and Factors Contributing to Low Back Pain in the Nonobstetrical Patients Operated Under Spinal Anesthesia: A Prospective 1-Year Follow-Up Study. J Perianesth Nurs. 2020 Feb;35(1):34-37. doi: 10.1016/j.jopan.2019.06.008. Epub 2019 Oct 18.
Bhardwaj D, Thakur L, Sharma S, Rana S, Gupta B, Sharma C. Comparative evaluation of three techniques for paramedian subarachnoid block: Point-of-care preprocedural ultrasound assisted, real-time ultrasound guided and landmark based. Indian J Anaesth. 2022 Mar;66(Suppl 2):S102-S107. doi: 10.4103/ija.ija_373_21. Epub 2022 Mar 25.
Betran AP, Ye J, Moller AB, Zhang J, Gulmezoglu AM, Torloni MR. The Increasing Trend in Caesarean Section Rates: Global, Regional and National Estimates: 1990-2014. PLoS One. 2016 Feb 5;11(2):e0148343. doi: 10.1371/journal.pone.0148343. eCollection 2016.
Bajwa SJ, Bajwa SK. Anaesthetic challenges and management during pregnancy: Strategies revisited. Anesth Essays Res. 2013 May-Aug;7(2):160-7. doi: 10.4103/0259-1162.118945.
At A, So O. Failed spinal anaesthesia for caesarean section. J West Afr Coll Surg. 2011 Oct;1(4):1-17.
Ansari T, Yousef A, El Gamassy A, Fayez M. Ultrasound-guided spinal anaesthesia in obstetrics: is there an advantage over the landmark technique in patients with easily palpable spines? Int J Obstet Anesth. 2014 Aug;23(3):213-6. doi: 10.1016/j.ijoa.2014.03.001. Epub 2014 Mar 12.
Primary Completion
August 30, 2025
Actual (reported)Study Completion
November 30, 2025
Actual (reported)Last Updated
May 22, 2026
Record last verified: 2026-05
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