Cesarean SectionNCT07601542
"Ultrasound vs. Landmark Technique for Spinal Anesthesia in Obese Women Undergoing Cesarean Section"
A study testing Landmark-Guided Spinal Anesthesia and Ultrasound-Assisted Spinal Anesthesia in people with Cesarean Section and Obese Parturient, run by Bangladesh Medical University at 1 site in Bangladesh.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cesarean Section, Obese Parturient, Ultrasound Guided Subarachnoid Block
- What is being tested?
- Landmark-Guided Spinal Anesthesia and Ultrasound-Assisted Spinal Anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Feb 2025to 30 Nov 2025
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Elective caesarean section
- ASA physical status: Ⅱ
- Obese parturient (BMI ≥ 30.1 kg/m²)
Who cannot join
- Allergic to local anaesthetic (0.5% Bupivacaine hydrochloride with 8% Dextrose and 2 % Lidocaine hydrochloride USP)
- Preexisting neurological deficit by clinical examination
- Any contraindication to SAB
- History of scoliosis or spinal instrumentation
- Allergy to ultrasound transmission gel
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Ultrasound Assisted Localisation of the Intervertebral Space Versus the Traditional Landmark Technique During Subarachnoid Block for Caesarean Section in Obese Parturient
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?
Read more
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.
Read the detailed description
This clinical trial is designed to compare two techniques for performing subarachnoid block (SAB) in obese women undergoing elective cesarean sections. The study aims to evaluate the effectiveness and safety of ultrasound-assisted spinal anesthesia versus the traditional landmark-guided technique. Both techniques are commonly used for regional anesthesia, but the effectiveness of ultrasound assistance in improving procedural accuracy, reducing complications, and enhancing the overall success rate in obese parturient has not been sufficiently studied.
Study Design
This is a randomized controlled trial conducted at the Obstetric Operating Theatre of Bangladesh Medical University (BMU). Participants will be randomly assigned to one of two groups: Group A (landmark technique) and Group B (ultrasound-assisted technique). The study will evaluate the following:
Primary Objective:
To assess the number of needle attempts required for successful subarachnoid block in both groups.
Secondary Objectives:
To evaluate the procedure time, incidence of post-dural puncture headache (PDPH), chronic low back pain at the needle insertion site, and quality of life related to pain.
Interventions
Both groups will receive the same local anesthetic agents for the SAB: 0.5% hyperbaric bupivacaine with 25 μg fentanyl. The techniques will differ in how the intervertebral space is located.
Group A (Landmark Technique): In this technique, the L3-L4 or L4-L5 intervertebral spaces will be identified using the traditional landmark method. The anesthesiologist will palpate the iliac crests to find Tuffier's line and will estimate the intervertebral space based on these bony landmarks.
Group B (Ultrasound-Assisted Technique): In this group, ultrasound guidance will be used to locate the intervertebral space. A low-frequency (2-5 MHz) curvilinear probe will be employed to visualize the lumbar spine. The procedure will include scanning the area to identify the midline, the interlaminar spaces, and the depth of the epidural and spinal spaces, ensuring that the correct intervertebral level is identified before needle insertion.
Randomization
Participants will be randomly assigned to one of the two intervention groups using Block randomization schedule. This will ensure that both groups are comparable at baseline and that the results are unbiased.
Procedure
Before the procedure, participants will undergo routine preoperative assessment, including fasting for 6 hours, intravenous line establishment, and monitoring. They will be positioned in a sitting position with a pillow for lumbar flexion. After preparing the skin with aseptic techniques, the spinal needle will be inserted according to the assigned technique.
In Group A, after identifying the L3-L4 or L4-L5 intervertebral space using the landmark technique, the anesthesiologist will administer the Subarachnoid Block (SAB). In Group B, ultrasound will be used to precisely identify the lumbar intervertebral spaces before needle insertion.
Follow-Up
Participants will be monitored for immediate postoperative complications, including Postdural puncture headache (PDPH), and will be assessed for chronic low back pain at the needle insertion after 3 months over phone. Additionally, the quality of life related to low back pain will be evaluated via phone interviews.
Expected Outcomes
The primary hypothesis is that the ultrasound-assisted technique will result in fewer needle attempts and a more accurate identification of the intervertebral space compared to the traditional landmark technique. Additionally, investigators expect to find that ultrasound assistance reduces the incidence of Postdural puncture headache (PDPH) and chronic low back pain, thereby improving the patient's overall quality of life postoperatively.
This trial will provide valuable insights into the effectiveness of ultrasound in improving the safety and accuracy of Subarachnoid Block (SAB) in obese parturient, potentially changing the standard of care in obstetric anesthesia for this patient population.
- Being tested
- Landmark-Guided Spinal Anesthesia, Ultrasound-Assisted Spinal Anesthesia
- Keywords
- Obese parturient, Cesarean Section, Subarachnoid block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Landmark-Guided Spinal AnesthesiaProcedure or surgery
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.
Ultrasound-Assisted Spinal AnesthesiaProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Landmark-Guided Spinal Anesthesia | Active comparator | 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. Receives: Procedure: Landmark-Guided Spinal Anesthesia |
| Group B: Ultrasound-Assisted Spinal Anesthesia | Experimental | 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. Receives: Procedure: Ultrasound-Assisted Spinal Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the procedure, until successful spinal needle placement
Secondary outcomes (5)
Needle Insertion Site Accuracy in landmark technique group
This measure evaluates whether the correct intervertebral space was identified and the needle was inserted at the intended location. Accuracy will be assessed using ultrasound imaging in the recovery room to verify the spinal leve
Measured: Immediately after transferring the participants in the recovery room
Procedure Duration in minutes
This outcome will assess the time taken to perform the spinal anesthesia procedure from the beginning of patient positioning for spinal anaesthesia to the successful Spinal Needle insertion.
Measured: During procedure
Incidence of Post-Dural Puncture Headache (PDPH)
The incidence of PDPH will be recorded in the immediate postoperative period. Participants will be monitored for symptoms such as headache, nausea, and neck stiffness, which are common after dural puncture.
Measured: Postoperative period (up to 72 hours)
Chronic Low Back Pain at Needle Insertion Site
Chronic low back pain at the needle insertion site will be evaluated via phone follow-up using the Numerical Rating Scale (NRS) to assess pain intensity. The impact on daily activities, including work, sleep disturbances, and mobility, will also be documented
Measured: 3 months post-procedure
Impact of Chronic Low Back Pain on Quality of Life
Quality of life is assessed using the 12-Item Short Form Health Survey (SF-12), a validated, widely used questionnaire measuring health-related quality of life across two domains:
Physical Component Summary (PCS): captures physical functioning, bodily pain, and general physical health.
Mental Component Summary (MCS): captures emotional well-being, social functioning, vitality, and mental health.
Responses are collected via phone interview by trained study staff. Data are coded according to Short-Form-12 (SF-12) guidelines and aggregated into summary scores.
Score Range: 0-100, with higher scores indicating better quality of life (less limitation or distress).
Measured: 3 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Feb 2025
- Primary completion30 Aug 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangladesh Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kazi Mahzabin Arin, Bangladesh Medical University
- Investigators
- AKM Akhtaruzzaman, MD, Study director, Bangladesh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601542
- Sponsor's protocol ID
- 5294
- Status last verified
- May 2026
- First submitted
- 8 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21114209Srinivasan 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.
PubMed 29416151Sahin 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.
PubMed 24141882Kurdi 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.
PubMed 36970484Khan 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.
PubMed 35663223Gayathri 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.
PubMed 34349367Forozeshfard 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.
PubMed 31635919Bhardwaj 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.
PubMed 35601040Betran 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.
PubMed 26849801Bajwa 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.
PubMed 25885826At A, So O. Failed spinal anaesthesia for caesarean section. J West Afr Coll Surg. 2011 Oct;1(4):1-17.
PubMed 25452968Ansari 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.
PubMed 24768303
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ultrasound Assisted Localisation of the Intervertebral Space Versus the Traditional Landmark Technique During Subarachnoid Block for Caesarean Section in Obese Parturient
- ClinicalTrials.gov ID
- NCT07601542
- Acronym / sponsor ID
- 5294
- Keywords
- Obese parturient, Cesarean Section, Subarachnoid block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Bangladesh Medical UniversityUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This clinical trial is designed to compare two techniques for performing subarachnoid block (SAB) in obese women undergoing elective cesarean sections. The study aims to evaluate the effectiveness and safety of ultrasound-assisted spinal anesthesia versus the traditional landmark-guided technique. Both techniques are commonly used for regional anesthesia, but the effectiveness of ultrasound assistance in improving procedural accuracy, reducing complications, and enhancing the overall success rate in obese parturient has not been sufficiently studied.
Study Design
This is a randomized controlled trial conducted at the Obstetric Operating Theatre of Bangladesh Medical University (BMU). Participants will be randomly assigned to one of two groups: Group A (landmark technique) and Group B (ultrasound-assisted technique). The study will evaluate the following:
Primary Objective:
To assess the number of needle attempts required for successful subarachnoid block in both groups.
Secondary Objectives:
To evaluate the procedure time, incidence of post-dural puncture headache (PDPH), chronic low back pain at the needle insertion site, and quality of life related to pain.
Interventions
Both groups will receive the same local anesthetic agents for the SAB: 0.5% hyperbaric bupivacaine with 25 μg fentanyl. The techniques will differ in how the intervertebral space is located.
Group A (Landmark Technique): In this technique, the L3-L4 or L4-L5 intervertebral spaces will be identified using the traditional landmark method. The anesthesiologist will palpate the iliac crests to find Tuffier's line and will estimate the intervertebral space based on these bony landmarks.
Group B (Ultrasound-Assisted Technique): In this group, ultrasound guidance will be used to locate the intervertebral space. A low-frequency (2-5 MHz) curvilinear probe will be employed to visualize the lumbar spine. The procedure will include scanning the area to identify the midline, the interlaminar spaces, and the depth of the epidural and spinal spaces, ensuring that the correct intervertebral level is identified before needle insertion.
Randomization
Participants will be randomly assigned to one of the two intervention groups using Block randomization schedule. This will ensure that both groups are comparable at baseline and that the results are unbiased.
Procedure
Before the procedure, participants will undergo routine preoperative assessment, including fasting for 6 hours, intravenous line establishment, and monitoring. They will be positioned in a sitting position with a pillow for lumbar flexion. After preparing the skin with aseptic techniques, the spinal needle will be inserted according to the assigned technique.
In Group A, after identifying the L3-L4 or L4-L5 intervertebral space using the landmark technique, the anesthesiologist will administer the Subarachnoid Block (SAB). In Group B, ultrasound will be used to precisely identify the lumbar intervertebral spaces before needle insertion.
Follow-Up
Participants will be monitored for immediate postoperative complications, including Postdural puncture headache (PDPH), and will be assessed for chronic low back pain at the needle insertion after 3 months over phone. Additionally, the quality of life related to low back pain will be evaluated via phone interviews.
Expected Outcomes
The primary hypothesis is that the ultrasound-assisted technique will result in fewer needle attempts and a more accurate identification of the intervertebral space compared to the traditional landmark technique. Additionally, investigators expect to find that ultrasound assistance reduces the incidence of Postdural puncture headache (PDPH) and chronic low back pain, thereby improving the patient's overall quality of life postoperatively.
This trial will provide valuable insights into the effectiveness of ultrasound in improving the safety and accuracy of Subarachnoid Block (SAB) in obese parturient, potentially changing the standard of care in obstetric anesthesia for this patient population.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Landmark-Guided Spinal Anesthesia | Active comparator | Procedure: Landmark-Guided Spinal AnesthesiaIn 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. |
| Group B: Ultrasound-Assisted Spinal Anesthesia | Experimental | Procedure: Ultrasound-Assisted Spinal AnesthesiaIn 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Elective caesarean section
- ASA physical status: Ⅱ
- Obese parturient (BMI ≥ 30.1 kg/m²)
Key exclusion criteria (5 listed)
- Allergic to local anaesthetic (0.5% Bupivacaine hydrochloride with 8% Dextrose and 2 % Lidocaine hydrochloride USP)
- Preexisting neurological deficit by clinical examination
- Any contraindication to SAB
- History of scoliosis or spinal instrumentation
- Allergy to ultrasound transmission gel
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Landmark-Guided Spinal AnesthesiaThis 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. | Procedure or surgery | Group A: Landmark-Guided Spinal Anesthesia |
| Ultrasound-Assisted Spinal AnesthesiaThis 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. | Procedure or surgery | Group B: Ultrasound-Assisted Spinal Anesthesia |
Primary outcome
Number of Needle Attempts for Successful Subarachnoid Block
Time frame: During the procedure, until successful spinal needle placement
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.
5 secondary outcomes
Needle Insertion Site Accuracy in landmark technique group
Time frame: Immediately after transferring the participants in the recovery room
Procedure Duration in minutes
Time frame: During procedure
Incidence of Post-Dural Puncture Headache (PDPH)
Time frame: Postoperative period (up to 72 hours)
Chronic Low Back Pain at Needle Insertion Site
Time frame: 3 months post-procedure
Impact of Chronic Low Back Pain on Quality of Life
Time frame: 3 months post-procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Background: PubMed 21114209Wattanaruangkowit 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.
- Background: PubMed 29416151Srinivasan 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.
- Background: PubMed 24141882Sahin 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.
- Background: PubMed 36970484Kurdi 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.
- Background: PubMed 35663223Khan 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.
- Background: PubMed 34349367Gayathri 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.
- Background: PubMed 31635919Forozeshfard 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.
- Background: PubMed 35601040Bhardwaj 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.
- Background: PubMed 26849801Betran 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.
- Background: PubMed 25885826Bajwa 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.
- Background: PubMed 25452968At A, So O. Failed spinal anaesthesia for caesarean section. J West Afr Coll Surg. 2011 Oct;1(4):1-17.
- Background: PubMed 24768303Ansari 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Postpartum Hemorrhage, Uterine Atony
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Active, not recruiting
Implementation of a Disparities in Labor Outcomes Dashboard
Labor Induction, Cesarean Birth
RecruitingPhase 1
Ketamine Pharmacokinetics and Pharmacodynamics for Postpartum Depression and Pain After Cesarean Delivery
Pain, Postpartum Depression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AKM Akhtaruzzaman, MD study director
Bangladesh Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Landmark-Guided Spinal Anesthesia and Ultrasound-Assisted Spinal Anesthesia in people with Cesarean Section and Obese Parturient, 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 3 inclusion and 5 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 22 May 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?
Number of Needle Attempts for Successful Subarachnoid Block (time frame: During the procedure, until successful spinal needle placement). 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 NCT07601542, which also lists 12 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 22 May 2026.