Cancer SurgeryNCT06707571
Landmark Versus Ultrasongraphy Guided Spinal Anesthesia in Lower Abdominal Surgeries in Cancer Patients: a Randomized Controlled Trial
A study testing spinal anesthesia in people with Cancer Surgery, run by Assiut University.
Trial summary
Spinal anesthesia is a commonly employed technique for lower abdominal surgeries, providing effective anesthesia and analgesia with minimal systemic effects. In cancer patients undergoing such procedures, careful consideration of anesthetic techniques is crucial, given their often-compromised physiological state and… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer Surgery
- What is being tested?
- spinal anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years old
- Both sex
- patients with a body mass index (BMI) of 18-40 kg/m2
- American Society of Anesthesiologists (ASA) physical status classification of I to III.
Who cannot join
- • Patients have a contraindication for regional anesthesia, e.g. coagulopathy.
- Failed or unsatisfactory intrathecal block.
- Patients with known hypersensitivity to amide local anesthetics.
- Local injection site infection or spinal deformity.
- Severe hypotension.
- Space occupying lesions of the brain.
- Hypovolemia.
- Pregnancy.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Ultrasongraphy Guided Spinal Anesthesia Versus Landmark in Lower Abdominal Surgeries in Cancer Patients: a Randomized Controlled Trial
Spinal anesthesia is a commonly employed technique for lower abdominal surgeries, providing effective anesthesia and analgesia with minimal systemic effects. In cancer patients undergoing such procedures, careful consideration of anesthetic techniques is crucial, given their often-compromised physiological state and the need to minimize postoperative complications. Two approaches to administering spinal anesthesia are Ultrasound (US)-guided and the traditional landmark-based technique.
the aim of the study :To evaluate the efficacy, safety and feasibility of US-guided spinal anesthesia versus the landmark-based technique in cancer patients undergoing lower abdominal surgery.
Read the detailed description
The traditional landmark method relies on palpating anatomical structures, such as the iliac crests and spinal processes, to guide needle insertion. Although widely used, it can be challenging in patients with anatomical variations, obesity, or previous surgeries, potentially leading to multiple attempts, increased patient discomfort, or complications. On the other hand, Ultrasound (US) imaging has become an increasingly popular tool among anesthesiologists to guide neuraxial blockade. US-guided spinal anesthesia provides real-time visualization of the relevant anatomy, including the spinal canal, ligaments, and surrounding tissues, enabling more accurate needle placement. This technique has gained attention for its potential to improve success rates, reduce complications, and enhance patient comfort, particularly in complex cases such as cancer patients, where precision is vital.
By examining factors such as procedural success rates, patient comfort, complication rates, and overall outcomes, we can better understand the role of ultrasound guidance in optimizing anesthetic care for this vulnerable patient population.
- Conditions
- Cancer Surgery
- Being tested
- spinal anesthesia
- Keywords
- US-guided spinal anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal anesthesiaProcedure or surgery
spinal anesthesia after us-assisted technique
spinal anesthesiaProcedure or surgery
spinal anesthesia using the surface landmark-guided
| Study group | Role | What they receive |
|---|---|---|
| Landmark Group | Experimental | patients will receive spinal anesthesia using the surface landmark-guided Receives: Procedure: spinal anesthesia |
| Ultrasonography Group | Experimental | patients will receive spinal anesthesia after us-assisted technique Receives: Procedure: spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
the first-pass success rate of Combined spinal-epidural anesthesia
first-pass success was defined as the needle reaching the subarachnoid space within a single insertion attempt, without redirection
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cancer SurgeryStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maram Ashraf Zahr Eldeen, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06707571
- Sponsor's protocol ID
- landmark VS US guided
- Status last verified
- Nov 2024
- First submitted
- 25 Nov 2024
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Park SK, Yoo S, Kim WH, Lim YJ, Bahk JH, Kim JT. Ultrasound-assisted vs. landmark-guided paramedian spinal anaesthesia in the elderly: A randomised controlled trial. Eur J Anaesthesiol. 2019 Oct;36(10):763-771. doi: 10.1097/EJA.0000000000001029.
PubMed 31188153Li M, Ni X, Xu Z, Shen F, Song Y, Li Q, Liu Z. Ultrasound-Assisted Technology Versus the Conventional Landmark Location Method in Spinal Anesthesia for Cesarean Delivery in Obese Parturients: A Randomized Controlled Trial. Anesth Analg. 2019 Jul;129(1):155-161. doi: 10.1213/ANE.0000000000003795.
PubMed 30234528Coviello A, Iacovazzo C, Piccione I, Posillipo C, Barone MS, Ianniello M, de Siena AU, Cirillo D, Vargas M. Impact of Ultrasound-Assisted Method on Success Rate of Spinal Anesthesia Performed by Novice Trainees: A Retrospective Comparative Study. J Pers Med. 2023 Oct 21;13(10):1515. doi: 10.3390/jpm13101515.
PubMed 37888126Geng J, Chen XL, Wang XD, Guo XY, Li M. [Ultrasound imaging increases first-attempt success rate of neuraxial block in elderly patients]. Zhonghua Yi Xue Za Zhi. 2016 Nov 22;96(43):3459-3463. doi: 10.3760/cma.j.issn.0376-2491.2016.43.004. Chinese.
PubMed 27903338Zhu G, Wang X, Yang L. Real-time ultrasound-guided neuraxial anesthesia for cesarean section in parturients with previous internal fixation surgery for lumbar fracture: a case series. Quant Imaging Med Surg. 2023 Jan 1;13(1):529-535. doi: 10.21037/qims-22-223. Epub 2022 Oct 26. No abstract available.
PubMed 36620151Sahin 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 24141882Feng Q, Zhang L, Zhang M, Wen Y, Zhang P, Wang Y, Zeng Y, Wang J. Morphological parameters of fourth lumbar spinous process palpation: a three-dimensional reconstruction of computed tomography. J Orthop Surg Res. 2020 Jun 22;15(1):227. doi: 10.1186/s13018-020-01750-2.
PubMed 32571368
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasongraphy Guided Spinal Anesthesia Versus Landmark in Lower Abdominal Surgeries in Cancer Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06707571
- Acronym / sponsor ID
- landmark VS US guided
- Conditions
- Cancer Surgery
- Keywords
- US-guided spinal anesthesia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 27 Nov 2024 (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.
Spinal anesthesia is a commonly employed technique for lower abdominal surgeries, providing effective anesthesia and analgesia with minimal systemic effects. In cancer patients undergoing such procedures, careful consideration of anesthetic techniques is crucial, given their often-compromised physiological state and the need to minimize postoperative complications. Two approaches to administering spinal anesthesia are Ultrasound (US)-guided and the traditional landmark-based technique.
the aim of the study :To evaluate the efficacy, safety and feasibility of US-guided spinal anesthesia versus the landmark-based technique in cancer patients undergoing lower abdominal surgery.
Detailed description
The traditional landmark method relies on palpating anatomical structures, such as the iliac crests and spinal processes, to guide needle insertion. Although widely used, it can be challenging in patients with anatomical variations, obesity, or previous surgeries, potentially leading to multiple attempts, increased patient discomfort, or complications. On the other hand, Ultrasound (US) imaging has become an increasingly popular tool among anesthesiologists to guide neuraxial blockade. US-guided spinal anesthesia provides real-time visualization of the relevant anatomy, including the spinal canal, ligaments, and surrounding tissues, enabling more accurate needle placement. This technique has gained attention for its potential to improve success rates, reduce complications, and enhance patient comfort, particularly in complex cases such as cancer patients, where precision is vital.
By examining factors such as procedural success rates, patient comfort, complication rates, and overall outcomes, we can better understand the role of ultrasound guidance in optimizing anesthetic care for this vulnerable patient population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Landmark Group | Experimental | Procedure: spinal anesthesiapatients will receive spinal anesthesia using the surface landmark-guided |
| Ultrasonography Group | Experimental | Procedure: spinal anesthesiapatients will receive spinal anesthesia after us-assisted technique |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age >18 years old
- Both sex
- patients with a body mass index (BMI) of 18-40 kg/m2
- American Society of Anesthesiologists (ASA) physical status classification of I to III.
Key exclusion criteria (8 listed)
- • Patients have a contraindication for regional anesthesia, e.g. coagulopathy.
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 |
|---|---|---|
| spinal anesthesiaspinal anesthesia after us-assisted technique | Procedure or surgery | Ultrasonography Group |
| spinal anesthesiaspinal anesthesia using the surface landmark-guided | Procedure or surgery | Landmark Group |
Primary outcome
the first-pass success rate of Combined spinal-epidural anesthesia
Time frame: baseline
first-pass success was defined as the needle reaching the subarachnoid space within a single insertion attempt, without redirection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Background: PubMed 31188153Park SK, Yoo S, Kim WH, Lim YJ, Bahk JH, Kim JT. Ultrasound-assisted vs. landmark-guided paramedian spinal anaesthesia in the elderly: A randomised controlled trial. Eur J Anaesthesiol. 2019 Oct;36(10):763-771. doi: 10.1097/EJA.0000000000001029.
- Background: PubMed 30234528Li M, Ni X, Xu Z, Shen F, Song Y, Li Q, Liu Z. Ultrasound-Assisted Technology Versus the Conventional Landmark Location Method in Spinal Anesthesia for Cesarean Delivery in Obese Parturients: A Randomized Controlled Trial. Anesth Analg. 2019 Jul;129(1):155-161. doi: 10.1213/ANE.0000000000003795.
- Background: PubMed 37888126Coviello A, Iacovazzo C, Piccione I, Posillipo C, Barone MS, Ianniello M, de Siena AU, Cirillo D, Vargas M. Impact of Ultrasound-Assisted Method on Success Rate of Spinal Anesthesia Performed by Novice Trainees: A Retrospective Comparative Study. J Pers Med. 2023 Oct 21;13(10):1515. doi: 10.3390/jpm13101515.
- Background: PubMed 27903338Geng J, Chen XL, Wang XD, Guo XY, Li M. [Ultrasound imaging increases first-attempt success rate of neuraxial block in elderly patients]. Zhonghua Yi Xue Za Zhi. 2016 Nov 22;96(43):3459-3463. doi: 10.3760/cma.j.issn.0376-2491.2016.43.004. Chinese.
- Background: PubMed 36620151Zhu G, Wang X, Yang L. Real-time ultrasound-guided neuraxial anesthesia for cesarean section in parturients with previous internal fixation surgery for lumbar fracture: a case series. Quant Imaging Med Surg. 2023 Jan 1;13(1):529-535. doi: 10.21037/qims-22-223. Epub 2022 Oct 26. No abstract available.
- 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 32571368Feng Q, Zhang L, Zhang M, Wen Y, Zhang P, Wang Y, Zeng Y, Wang J. Morphological parameters of fourth lumbar spinous process palpation: a three-dimensional reconstruction of computed tomography. J Orthop Surg Res. 2020 Jun 22;15(1):227. doi: 10.1186/s13018-020-01750-2.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing spinal anesthesia in people with Cancer Surgery, run by Assiut University.
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 8 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: opening soon, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maram Ashraf Zahr Eldeen, resident doctor (+201222201740, maramashraf493@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the first-pass success rate of Combined spinal-epidural anesthesia (time frame: baseline). 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 NCT06707571, which also lists 7 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 27 Nov 2024.