Spinal AnesthesiaNCT07088432
Intravenous Dexamethasone for Prolonging Sensory Block in Spinal Anesthesia
A study testing Dexamethasone in people with Spinal Anesthesia and Postoperative Pain Management, run by Tunis University at 1 site in Tunisia.
Trial summary
The goal of this clinical trial is to learn if intravenous dexamethasone can help prolong the effect of spinal anesthesia in adults having elective pelvic, urologic, or proctologic surgery. The study also looks at whether dexamethasone improves pain control after surgery and whether it causes any side effects. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Spinal Anesthesia, Postoperative Pain Management, Dexamethasone
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Oct 2023to 30 Jun 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18 to 80 years
- ASA physical status I or II
- Scheduled for elective pelvic surgery under spinal anesthesia (urologic, inguinal, or proctologic procedures)
- Provided informed consent
Who cannot join
- Known allergy to dexamethasone or local anaesthetics
- Contraindications to spinal anesthesia
- Neurological diseases
- Chronic use of corticosteroids or immunosuppressants
- BMI > 40 kg/m²
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Dexamethasone for Prolonging the Sensory Block Duration of Spinal Anesthesia: A Randomized Controlled Trial
The goal of this clinical trial is to learn if intravenous dexamethasone can help prolong the effect of spinal anesthesia in adults having elective pelvic, urologic, or proctologic surgery. The study also looks at whether dexamethasone improves pain control after surgery and whether it causes any side effects.
The main questions it aims to answer are:
Read more
Does intravenous dexamethasone increase how long the spinal anesthesia lasts?
Does it reduce the need for pain medications after surgery?
Does it cause more or fewer side effects compared to a placebo?
In this study:
Participants were randomly assigned to receive either 8 mg of intravenous dexamethasone or a placebo (salt water).
All participants received standard spinal anesthesia with bupivacaine and sufentanil.
Researchers measured how long the spinal anesthesia lasted and when the first pain medication was needed after surgery.
Participants were monitored for side effects such as low blood pressure, nausea, vomiting, and slow heart rate.
Surgeon satisfaction with anesthesia quality was also recorded.
Participants did not receive any additional procedures beyond routine care. The study found that dexamethasone helped prolong the spinal anesthesia and delayed the need for pain relief, without increasing side effects.
- Conditions
- Spinal Anesthesia, Postoperative Pain Management, Dexamethasone, Pelvic Surgery, Urologic Surgery, Proctologic Surgery
- Being tested
- Dexamethasone, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Single intravenous injection of 8 mg dexamethasone (2 mL) administered 5 minutes before spinal anesthesia. This intervention was tested for its effect on prolonging the duration of sensory and motor blocks induced by hyperbaric bupivacaine combined with sufentanil. The drug was administered under sterile conditions by an anesthesiologist blinded to group allocation.
PlaceboDrug
Single intravenous injection of 2 mL isotonic saline (0.9% NaCl) administered 5 minutes before spinal anesthesia. This placebo was used to mimic the dexamethasone injection in the control group. The preparation, volume, and timing were identical to the intervention group to maintain blinding. The saline was administered under sterile conditions by an anesthesiologist blinded to group allocation.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Dexamethasone Group | Experimental | Participants in this arm received 8 mg of intravenous dexamethasone (2 mL) 5 minutes before spinal anesthesia. The spinal anesthesia was performed with 12.5 mg of 0.5% hyperbaric bupivacaine combined with 2.5 µg of sufentanil. The purpose was to evaluate whether intravenous dexamethasone prolongs the duration of sensory and motor block and improves postoperative analgesia. Receives: Drug: Dexamethasone |
| Placebo Group | Placebo comparator | Participants in this arm received 2 mL of isotonic saline intravenously 5 minutes before spinal anesthesia. The spinal anesthesia was performed identically to the intervention group (12.5 mg of hyperbaric bupivacaine + 2.5 µg sufentanil). This arm served as the control group for evaluating the effects of dexamethasone. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of sensory block
The duration of the sensory block was defined as the time from intrathecal injection of the local anesthetic until regression of sensory level to the L1 dermatome, as assessed by pinprick test every 15 minutes postoperatively. This endpoint was selected to evaluate the effect of intravenous dexamethasone on prolonging the duration of spinal anesthesia.
Measured: From the time of spinal injection until sensory regression to L1 dermatome (up to 4 hours postoperatively)
Secondary outcomes (4)
Duration of motor block
The duration of the motor block was defined as the time from intrathecal injection until achieving a modified Bromage score of 3, which corresponds to partial motor recovery (able to move knees). The modified Bromage score was assessed every 15 minutes postoperatively. This measure was used to assess whether intravenous dexamethasone prolongs motor block following spinal anesthesia.
Measured: From the time of spinal injection until modified Bromage score = 3 (up to 4 hours postoperatively)
Time to first analgesic request
Time from intrathecal injection to the first request for postoperative analgesia, defined as the moment when the patient reported a pain score ≥ 3 on a visual analog scale (VAS, 0-10). This was recorded in minutes starting from the time of spinal anesthesia. The aim was to assess whether intravenous dexamethasone prolongs the duration of effective postoperative analgesia.
Measured: From spinal injection until VAS score ≥ 3 and first analgesic request (up to 6 hours postoperatively)
Incidence of adverse events
Adverse events occurring during the surgical procedure were systematically recorded. These included hypotension (systolic BP < 90 mmHg), bradycardia (HR < 50 bpm), nausea, vomiting, pruritus, and any signs of discomfort or neurological complications. All events were recorded as present or absent and compared between the dexamethasone and placebo groups to assess the safety profile of intravenous dexamethasone during spinal anesthesia.
Measured: From spinal injection until the end of surgery
Surgeon satisfaction score
Surgeon satisfaction with the quality of intraoperative anesthesia was assessed using a binary score (Satisfied / Not satisfied). The evaluation was based on intraoperative conditions such as patient immobility, comfort, and adequacy of anesthesia. The rating was collected at the end of surgery to compare the perceived quality between the dexamethasone and placebo groups.
Measured: Immediately after the end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start1 Oct 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal AnesthesiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, parallel, randomized controlled trial with 1:1 allocation
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tunis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kamel ben Fadhel, Tunis University
- Investigators
- Samia Arfaoui, Medical Doctor, Study director, Habib Thameur HospitalKamel Ben Fadhel, Medical Doctor, Study chair, Habib Thameur Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088432
- Sponsor's protocol ID
- HTHEC-2023-26
- Status last verified
- Jul 2025
- First submitted
- 19 Jul 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Dexamethasone for Prolonging the Sensory Block Duration of Spinal Anesthesia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07088432
- Acronym / sponsor ID
- HTHEC-2023-26
- Conditions
- Spinal Anesthesia, Postoperative Pain Management, Dexamethasone, Pelvic Surgery, Urologic Surgery, Proctologic Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Tunis UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 28 Jul 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.
The goal of this clinical trial is to learn if intravenous dexamethasone can help prolong the effect of spinal anesthesia in adults having elective pelvic, urologic, or proctologic surgery. The study also looks at whether dexamethasone improves pain control after surgery and whether it causes any side effects.
The main questions it aims to answer are:
Does intravenous dexamethasone increase how long the spinal anesthesia lasts?
Does it reduce the need for pain medications after surgery?
Does it cause more or fewer side effects compared to a placebo?
In this study:
Participants were randomly assigned to receive either 8 mg of intravenous dexamethasone or a placebo (salt water).
All participants received standard spinal anesthesia with bupivacaine and sufentanil.
Researchers measured how long the spinal anesthesia lasted and when the first pain medication was needed after surgery.
Participants were monitored for side effects such as low blood pressure, nausea, vomiting, and slow heart rate.
Surgeon satisfaction with anesthesia quality was also recorded.
Participants did not receive any additional procedures beyond routine care. The study found that dexamethasone helped prolong the spinal anesthesia and delayed the need for pain relief, without increasing side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Two-arm, parallel, randomized controlled trial with 1:1 allocation
| Arm | Type | Receives |
|---|---|---|
| Intravenous Dexamethasone Group | Experimental | Drug: DexamethasoneParticipants in this arm received 8 mg of intravenous dexamethasone (2 mL) 5 minutes before spinal anesthesia. The spinal anesthesia was performed with 12.5 mg of 0.5% hyperbaric bupivacaine combined with 2.5 µg of sufentanil. The purpose was to evaluate whether intravenous dexamethasone prolongs the duration of sensory and motor block and improves postoperative analgesia. |
| Placebo Group | Placebo comparator | Drug: PlaceboParticipants in this arm received 2 mL of isotonic saline intravenously 5 minutes before spinal anesthesia. The spinal anesthesia was performed identically to the intervention group (12.5 mg of hyperbaric bupivacaine + 2.5 µg sufentanil). This arm served as the control group for evaluating the effects of dexamethasone. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients aged 18 to 80 years
- ASA physical status I or II
- Scheduled for elective pelvic surgery under spinal anesthesia (urologic, inguinal, or proctologic procedures)
- Provided informed consent
Key exclusion criteria (6 listed)
- Known allergy to dexamethasone or local anaesthetics
- Contraindications to spinal anesthesia
- Neurological diseases
- Chronic use of corticosteroids or immunosuppressants
- BMI > 40 kg/m²
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 |
|---|---|---|
| DexamethasoneSingle intravenous injection of 8 mg dexamethasone (2 mL) administered 5 minutes before spinal anesthesia. This intervention was tested for its effect on prolonging the duration of sensory and motor blocks induced by hyperbaric bupivacaine combined with sufentanil. The drug was administered under sterile conditions by an anesthesiologist blinded to group allocation. | Drug | Intravenous Dexamethasone Group |
| PlaceboSingle intravenous injection of 2 mL isotonic saline (0.9% NaCl) administered 5 minutes before spinal anesthesia. This placebo was used to mimic the dexamethasone injection in the control group. The preparation, volume, and timing were identical to the intervention group to maintain blinding. The saline was administered under sterile conditions by an anesthesiologist blinded to group allocation. | Drug | Placebo Group |
Primary outcome
Duration of sensory block
Time frame: From the time of spinal injection until sensory regression to L1 dermatome (up to 4 hours postoperatively)
The duration of the sensory block was defined as the time from intrathecal injection of the local anesthetic until regression of sensory level to the L1 dermatome, as assessed by pinprick test every 15 minutes postoperatively. This endpoint was selected to evaluate the effect of intravenous dexamethasone on prolonging the duration of spinal anesthesia.
4 secondary outcomes
Duration of motor block
Time frame: From the time of spinal injection until modified Bromage score = 3 (up to 4 hours postoperatively)
Time to first analgesic request
Time frame: From spinal injection until VAS score ≥ 3 and first analgesic request (up to 6 hours postoperatively)
Incidence of adverse events
Time frame: From spinal injection until the end of surgery
Surgeon satisfaction score
Time frame: Immediately after the end of surgery
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 28 Jul 2025.
- 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. This study is not recruiting at the moment.
Samia Arfaoui, Medical Doctor study director
Habib Thameur Hospital
Kamel Ben Fadhel, Medical Doctor study chair
Habib Thameur Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexamethasone in people with Spinal Anesthesia and Postoperative Pain Management, run by Tunis University at 1 site in Tunisia.
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 6 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 28 Jul 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 Tunisia. 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?
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?
Duration of sensory block (time frame: From the time of spinal injection until sensory regression to L1 dermatome (up to 4 hours postoperatively)). 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 28 Jul 2025.