Spinal AnesthesiaPhase 4NCT07088146
Dexamethasone in Prolonging the Duration of Spinal Anesthesia Among Pregnant Patients
A Phase 4 study testing Dexamethasone in people with Spinal Anesthesia and Post Operative Analgesia, run by Rawalpindi Medical College at 1 site in Pakistan.
Trial summary
Lower segment C section is one of the most commonly performed surgeries worldwide. It is performed in spinal anesthesia. During Spinal Anesthesia a local anesthetic drug is administered in a space surrounding spinal cord and it blocks nerves originating from spinal cord providing both anesthesia and analgesia. Read more about this study
- Who is it for?
- Ages 16 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Spinal Anesthesia, Post Operative Analgesia
- 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
- 110 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Jul 2025to 20 Oct 2025
- Phase
- Phase 4
- 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 16 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) class: II and above.
- Elective Cesarean section under Spinal Anesthesia.
Who cannot join
- Gestational diabetes
- Body mass index >35 kg/m2
- Diabetes mellitus
- Adrenal insufficiency
- Chronically receiving steroids
- Allergic to study medications
- Sensory block level less than T4
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Benazir Bhutto Hospital Rawalpindi
Rawalpindi, Punjab Province, 46000
Huda Tariq, MBBS, +92-321-8829143, Huda8829@gmail.com
Abeera Zareen, MBBS, FCPS, +92-332-8559637, abeerajsk@gmail.com
About this study
Official title: Role of Intravenous Dexamethasone in Prolonging the Duration of Sub-Arachnoid Block in Pregnant Patients Undergoing Lower Segment Cesarean Section
Lower segment C section is one of the most commonly performed surgeries worldwide. It is performed in spinal anesthesia. During Spinal Anesthesia a local anesthetic drug is administered in a space surrounding spinal cord and it blocks nerves originating from spinal cord providing both anesthesia and analgesia. This technique avoids harmful exposure of drugs to the baby inside the womb of mother. However this technique provides anesthesia and analgesia of limited duration which can be prolonged by addition of drugs to patient management regimen. One such drug is Dexamethasone which is a steroid commonly administered in the peri-operative period.
Read the detailed description
To prolong the duration of Sub-Arachnoid block number of drugs which are known as adjuvants can be used. One of the commonly used adjuvant is Dexamethasone a steroid given by intravenous route having anti-emetic and anti-inflammatory effect. This drug also prolongs the duration of Sub-Arachnoid block which can be helpful in case of lengthy surgical procedure and also extends the duration of analgesia in the post operative period.
- Conditions
- Spinal Anesthesia, Post Operative Analgesia
- Being tested
- Dexamethasone, Placebo
- Keywords
- Adjuvants, Sub-Arachnoid Block, C-section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Immediately after sub-arachnoid block 8mg of Dexamethasone will be administered intravenously
PlaceboDrug
2ml of Normal saline will be given intravenously immediately after administration of spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Group Dexamethasone | Experimental | Not described Receives: Drug: Dexamethasone |
| Group Control | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for block to regress by two dermatomes in post operative period
Measured: This will be the time in minutes from end of C section in post operative period for the block to regress by two dermatomes
Secondary outcomes (1)
Time to rescue analgesia
Measured: This will be the time in minutes from the end of Cesarean section in the post operative period to first rescue analgesia.
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 start20 Jul 2025
- Primary completion20 Oct 2025 (estimated)
- Study completion20 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rawalpindi Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huda Tariq, Rawalpindi Medical College
- Investigators
- Abeera Zareen, MBBS,FCPS, Study chair, Rawalpindi Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088146
- Sponsor's protocol ID
- 201/IREF/RMU/2025
- Status last verified
- Jul 2025
- First submitted
- 19 Jul 2025
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abdel-Wahab AH, Abd Alla ES, Abd El-Azeem T. Effect of intravenous dexamethasone on the duration of hyperbaric bupivacaine spinal anesthesia in lower abdominal surgery, Randomized controlled trial. BMC Anesthesiol. 2023 Sep 22;23(1):323. doi: 10.1186/s12871-023-02282-y.
PubMed 37736711
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
- Role of Intravenous Dexamethasone in Prolonging the Duration of Sub-Arachnoid Block in Pregnant Patients Undergoing Lower Segment Cesarean Section
- ClinicalTrials.gov ID
- NCT07088146
- Acronym / sponsor ID
- 201/IREF/RMU/2025
- Conditions
- Spinal Anesthesia, Post Operative Analgesia
- Keywords
- Adjuvants, Sub-Arachnoid Block, C-section
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Rawalpindi Medical CollegeUniversity, hospital or other
- Study start
- 20 Jul 2025 (actual)
- Primary completion
- 20 Oct 2025 (estimated)
- Study completion
- 20 Oct 2025 (estimated)
- 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.
Lower segment C section is one of the most commonly performed surgeries worldwide. It is performed in spinal anesthesia. During Spinal Anesthesia a local anesthetic drug is administered in a space surrounding spinal cord and it blocks nerves originating from spinal cord providing both anesthesia and analgesia. This technique avoids harmful exposure of drugs to the baby inside the womb of mother. However this technique provides anesthesia and analgesia of limited duration which can be prolonged by addition of drugs to patient management regimen. One such drug is Dexamethasone which is a steroid commonly administered in the peri-operative period.
Detailed description
To prolong the duration of Sub-Arachnoid block number of drugs which are known as adjuvants can be used. One of the commonly used adjuvant is Dexamethasone a steroid given by intravenous route having anti-emetic and anti-inflammatory effect. This drug also prolongs the duration of Sub-Arachnoid block which can be helpful in case of lengthy surgical procedure and also extends the duration of analgesia in the post operative period.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Dexamethasone | Experimental | Drug: Dexamethasone |
| Group Control | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 16 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) class: II and above.
- Elective Cesarean section under Spinal Anesthesia.
Key exclusion criteria (7 listed)
- Gestational diabetes
- Body mass index >35 kg/m2
- Diabetes mellitus
- Adrenal insufficiency
- Chronically receiving steroids
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 |
|---|---|---|
| DexamethasoneImmediately after sub-arachnoid block 8mg of Dexamethasone will be administered intravenously | Drug | Group Dexamethasone |
| Placebo2ml of Normal saline will be given intravenously immediately after administration of spinal anesthesia | Drug | Group Control |
Primary outcome
Time for block to regress by two dermatomes in post operative period
Time frame: This will be the time in minutes from end of C section in post operative period for the block to regress by two dermatomes
1 secondary outcome
Time to rescue analgesia
Time frame: This will be the time in minutes from the end of Cesarean section in the post operative period to first rescue analgesia.
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 28 Jul 2025.
- Results publication: PubMed 37736711Abdel-Wahab AH, Abd Alla ES, Abd El-Azeem T. Effect of intravenous dexamethasone on the duration of hyperbaric bupivacaine spinal anesthesia in lower abdominal surgery, Randomized controlled trial. BMC Anesthesiol. 2023 Sep 22;23(1):323. doi: 10.1186/s12871-023-02282-y.
- Related InfoLink provided by the sponsor.
- 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.
Abeera Zareen, MBBS,FCPS study chair
Rawalpindi Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone in people with Spinal Anesthesia and Post Operative Analgesia, run by Rawalpindi Medical College at 1 site in Pakistan.
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 2 inclusion and 7 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 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 Pakistan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Huda Tariq, MBBS (+92-321-8829413, Huda8829@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time for block to regress by two dermatomes in post operative period (time frame: This will be the time in minutes from end of C section in post operative period for the block to regress by two dermatomes). 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 NCT07088146, which also lists 1 linked publication.
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.