Pain ManagementNCT07198412
Effect of Sedation After Ultrasound-Guided Spinal Anesthesia on Back Pain
A study testing Ultrasound-guided spinal anesthesia, Midazolam plus ultrasound-guided spinal anesthesia and Landmark-guided spinal anesthesia in people with Pain Management and Postoperative Acute Pain, run by Benha University at 1 site in Egypt.
Trial summary
This study will evaluate whether giving sedation before spinal anesthesia, when performed with ultrasound guidance, reduces the risk of developing back pain after surgery. Spinal anesthesia is commonly used but may cause discomfort or persistent back pain in some patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain Management, Postoperative Acute Pain, Chronic Back Pain
- What is being tested?
- Ultrasound-guided spinal anesthesia, Midazolam plus ultrasound-guided spinal anesthesia and Landmark-guided spinal anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2025to 10 May 2026
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 years ASA physical status I-II Body Mass Index (BMI) ≤ 35 kg/m² Scheduled for elective non-obstetric lower abdominal or lower limb surgery under spinal anesthesia Able to provide written informed consent
Who cannot join
- Contraindications to spinal anesthesia (e.g., coagulopathy, local infection at puncture site) Pre-existing chronic low back pain Chronic opioid use Known allergy or contraindication to study medications (bupivacaine, lidocaine, midazolam) Psychiatric or neurological disorders affecting pain perception or reporting Severe spinal deformities or history of previous spinal surgery Inability to comply with follow-up assessments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Benha University Hospital
Banhā, Qalyubia Governorate, 13511
Samar R Amin, MD, +201287793991, samar.rafik@gmail.com
About this study
Official title: Impact of Ultrasound-Guided Spinal Anesthesia and Pre-Procedure Sedation on Postoperative Acute and Chronic Back Pain in Non-Obstetric Surgery.
This study will evaluate whether giving sedation before spinal anesthesia, when performed with ultrasound guidance, reduces the risk of developing back pain after surgery. Spinal anesthesia is commonly used but may cause discomfort or persistent back pain in some patients. By comparing standard techniques, ultrasound guidance, and sedation, we aim to find safer and more comfortable approaches for patients undergoing non-obstetric surgery.
Read the detailed description
Spinal anesthesia is widely used for abdominal and lower limb surgeries, yet a significant number of patients experience new back pain afterward, sometimes lasting for months. Contributing factors include needle size, multiple puncture attempts, and patient characteristics. Ultrasound guidance can improve accuracy and reduce complications, while pre-procedure sedation may lower anxiety and discomfort during the procedure.
This randomized controlled trial will include 180 adult patients scheduled for non-obstetric surgery. Participants will be divided into three groups:
Ultrasound-guided spinal anesthesia without sedation
Ultrasound-guided spinal anesthesia with sedation (midazolam)
Landmark-guided spinal anesthesia (control)
Sedation will be administered with midazolam before the spinal procedure in the sedation group. All patients will receive standardized anesthesia techniques. Pain will be assessed in the early postoperative period and during long-term follow-up (1, 3, and 6 months) using validated pain scales and questionnaires. Secondary outcomes include pain severity, number of needle attempts, procedure time, patient satisfaction, and complications such as headache or nausea.
This study will clarify whether combining ultrasound guidance with pre-procedure sedation can reduce both acute and chronic back pain after spinal anesthesia, aiming to improve patient safety, comfort, and satisfaction.
- Conditions
- Pain Management, Postoperative Acute Pain, Chronic Back Pain
- Being tested
- Ultrasound-guided spinal anesthesia, Midazolam plus ultrasound-guided spinal anesthesia, Landmark-guided spinal anesthesia
- Keywords
- Spinal anesthesia, Ultrasound-guided anesthesia, Pre-procedure sedation, Midazolam, Chronic back pain
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided spinal anesthesiaProcedure or surgery
Spinal anesthesia performed under real-time ultrasound guidance using a curvilinear ultrasound probe and 25-27G pencil-point spinal needle. Intrathecal injection of bupivacaine 0.5% hyperbaric (12-15 mg) following local infiltration with lidocaine 1% (2-3 mL).
Midazolam plus ultrasound-guided spinal anesthesiaDrug
Patients will receive midazolam (0.02-0.05 mg/kg IV; max 5 mg) 5-10 minutes prior to spinal anesthesia. Ultrasound guidance used for spinal needle placement. Intrathecal bupivacaine 0.5% hyperbaric (12-15 mg) after lidocaine 1% (2-3 mL) infiltration. Oxygen supplementation at 2 L/min and standard monitoring.
Landmark-guided spinal anesthesiaProcedure or surgery
Spinal anesthesia performed using the traditional landmark palpation technique without ultrasound guidance or sedation. Intrathecal bupivacaine 0.5% hyperbaric (12-15 mg) after lidocaine 1% (2-3 mL) infiltration, using a 25-27G pencil-point spinal needle.
| Study group | Role | What they receive |
|---|---|---|
| Arm A - Ultrasound-Guided Spinal Anesthesia (No Sedation) | Active comparator | Not described Receives: Procedure: Ultrasound-guided spinal anesthesia |
| Arm B - Ultrasound-Guided Spinal Anesthesia with Sedation (Midazolam) | Experimental | Not described Receives: Drug: Midazolam plus ultrasound-guided spinal anesthesia |
| Arm C - Landmark-Guided Spinal Anesthesia (Control) | Placebo comparator | Not described Receives: Procedure: Landmark-guided spinal anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Back Pain
Presence of pain or discomfort at the lower back or puncture site, assessed using a pain body map and Numeric Rating Scale (0-10). Evaluations will be performed both in the early postoperative period and during follow-up.
Measured: 24-48 hours postoperatively; 1 month, 3 months, and 6 months after surgery
Secondary outcomes (4)
Severity of Postoperative Back Pain
Intensity of back pain rated using the Numeric Rating Scale (0-10).
Measured: 24-48 hours; 1 month, 3 months, and 6 months postoperatively
Number of Needle Insertion Attempts
Documented as single attempt versus multiple attempts (>2).
Measured: During the procedure
Patient Satisfaction
Patient-reported satisfaction assessed using a 5-point Likert scale.
Measured: 24 hours postoperatively
Procedure-Related Complications
Incidence of post-dural puncture headache, nausea, vomiting, urinary retention, or neurological deficits.
Measured: Within 7 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start1 Oct 2025
- Primary completion10 Apr 2026 (estimated)
- Study completion10 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- More trials run by Benha 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Rafik Mohamed Amin, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198412
- Sponsor's protocol ID
- RC_7.8.2025
- Status last verified
- Nov 2025
- First submitted
- 15 Sep 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Ultrasound-Guided Spinal Anesthesia and Pre-Procedure Sedation on Postoperative Acute and Chronic Back Pain in Non-Obstetric Surgery.
- ClinicalTrials.gov ID
- NCT07198412
- Acronym / sponsor ID
- RC_7.8.2025
- Conditions
- Pain Management, Postoperative Acute Pain, Chronic Back Pain
- Keywords
- Spinal anesthesia, Ultrasound-guided anesthesia, Pre-procedure sedation, Midazolam, Chronic back pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 10 Apr 2026 (estimated)
- Study completion
- 10 May 2026 (estimated)
- First posted
- 30 Sep 2025 (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.
This study will evaluate whether giving sedation before spinal anesthesia, when performed with ultrasound guidance, reduces the risk of developing back pain after surgery. Spinal anesthesia is commonly used but may cause discomfort or persistent back pain in some patients. By comparing standard techniques, ultrasound guidance, and sedation, we aim to find safer and more comfortable approaches for patients undergoing non-obstetric surgery.
Detailed description
Spinal anesthesia is widely used for abdominal and lower limb surgeries, yet a significant number of patients experience new back pain afterward, sometimes lasting for months. Contributing factors include needle size, multiple puncture attempts, and patient characteristics. Ultrasound guidance can improve accuracy and reduce complications, while pre-procedure sedation may lower anxiety and discomfort during the procedure.
This randomized controlled trial will include 180 adult patients scheduled for non-obstetric surgery. Participants will be divided into three groups:
Ultrasound-guided spinal anesthesia without sedation
Ultrasound-guided spinal anesthesia with sedation (midazolam)
Landmark-guided spinal anesthesia (control)
Sedation will be administered with midazolam before the spinal procedure in the sedation group. All patients will receive standardized anesthesia techniques. Pain will be assessed in the early postoperative period and during long-term follow-up (1, 3, and 6 months) using validated pain scales and questionnaires. Secondary outcomes include pain severity, number of needle attempts, procedure time, patient satisfaction, and complications such as headache or nausea.
This study will clarify whether combining ultrasound guidance with pre-procedure sedation can reduce both acute and chronic back pain after spinal anesthesia, aiming to improve patient safety, comfort, and satisfaction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm A - Ultrasound-Guided Spinal Anesthesia (No Sedation) | Active comparator | Procedure: Ultrasound-guided spinal anesthesia |
| Arm B - Ultrasound-Guided Spinal Anesthesia with Sedation (Midazolam) | Experimental | Drug: Midazolam plus ultrasound-guided spinal anesthesia |
| Arm C - Landmark-Guided Spinal Anesthesia (Control) | Placebo comparator | Procedure: Landmark-guided spinal anesthesia |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 18-65 years ASA physical status I-II Body Mass Index (BMI) ≤ 35 kg/m² Scheduled for elective non-obstetric lower abdominal or lower limb surgery under spinal anesthesia Able to provide written informed consent
Key exclusion criteria (1 listed)
- Contraindications to spinal anesthesia (e.g., coagulopathy, local infection at puncture site) Pre-existing chronic low back pain Chronic opioid use Known allergy or contraindication to study medications (bupivacaine, lidocaine, midazolam) Psychiatric or neurological disorders affecting pain perception or reporting Severe spinal deformities or history of previous spinal surgery Inability to comply with follow-up assessments
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 |
|---|---|---|
| Ultrasound-guided spinal anesthesiaSpinal anesthesia performed under real-time ultrasound guidance using a curvilinear ultrasound probe and 25-27G pencil-point spinal needle. Intrathecal injection of bupivacaine 0.5% hyperbaric (12-15 mg) following local infiltration with lidocaine 1% (2-3 mL). | Procedure or surgery | Arm A - Ultrasound-Guided Spinal Anesthesia (No Sedation) |
| Midazolam plus ultrasound-guided spinal anesthesiaPatients will receive midazolam (0.02-0.05 mg/kg IV; max 5 mg) 5-10 minutes prior to spinal anesthesia. Ultrasound guidance used for spinal needle placement. Intrathecal bupivacaine 0.5% hyperbaric (12-15 mg) after lidocaine 1% (2-3 mL) infiltration. Oxygen supplementation at 2 L/min and standard monitoring. | Drug | Arm B - Ultrasound-Guided Spinal Anesthesia with Sedation (Midazolam) |
| Landmark-guided spinal anesthesiaSpinal anesthesia performed using the traditional landmark palpation technique without ultrasound guidance or sedation. Intrathecal bupivacaine 0.5% hyperbaric (12-15 mg) after lidocaine 1% (2-3 mL) infiltration, using a 25-27G pencil-point spinal needle. | Procedure or surgery | Arm C - Landmark-Guided Spinal Anesthesia (Control) |
Primary outcome
Incidence of Postoperative Back Pain
Time frame: 24-48 hours postoperatively; 1 month, 3 months, and 6 months after surgery
Presence of pain or discomfort at the lower back or puncture site, assessed using a pain body map and Numeric Rating Scale (0-10). Evaluations will be performed both in the early postoperative period and during follow-up.
4 secondary outcomes
Severity of Postoperative Back Pain
Time frame: 24-48 hours; 1 month, 3 months, and 6 months postoperatively
Number of Needle Insertion Attempts
Time frame: During the procedure
Patient Satisfaction
Time frame: 24 hours postoperatively
Procedure-Related Complications
Time frame: Within 7 days postoperatively
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 17 Nov 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided spinal anesthesia, Midazolam plus ultrasound-guided spinal anesthesia and Landmark-guided spinal anesthesia in people with Pain Management and Postoperative Acute Pain, run by Benha University at 1 site in Egypt.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 17 Nov 2025. 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 Egypt. 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. Some participants in this study may receive a placebo. 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 Samar R Amin, M.D. (+201287793991, samar.rafik@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Back Pain (time frame: 24-48 hours postoperatively; 1 month, 3 months, and 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Nov 2025.