Spinal AnesthesiaPhase 4NCT07718360
Effect of Single-Dose Dexamethasone on Postoperative Pain After Cesarean Section Under Spinal Anesthesia
A Phase 4 study testing Dexamethasone (IV) and Normal Saline 0.9% Infusion Solution in people with Spinal Anesthesia and Cesarean Section Pain, run by KRL Hospital, Islamabad at 1 site in Pakistan.
Trial summary
This study looked at whether giving a single dose of dexamethasone (a steroid medicine, 8 mg given into the vein) before a cesarean section could reduce pain after the operation. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Spinal Anesthesia, Cesarean Section Pain, Postoperative Pain
- What is being tested?
- Dexamethasone (IV) and Normal Saline 0.9% Infusion Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2024to 1 Sep 2024
- Phase
- Phase 4
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Female patients aged 18-40 years
- Scheduled for elective lower segment cesarean section (LSCS)
- Spinal anesthesia planned and suitable
- ASA physical status Class I or II
- Gestational age ≥ 37 weeks
- Willing to participate and able to provide written informed consent
Who cannot join
- Known allergy or hypersensitivity to dexamethasone or any corticosteroid
- Diabetes mellitus or uncontrolled hyperglycemia
- Current or recent (within 4 weeks) corticosteroid use
- Contraindication to spinal anesthesia (coagulopathy, infection at puncture site, patient refusal)
- Emergency cesarean section
- Systemic infection or sepsis
Show all 11Show fewer
- Significant hepatic, renal, or cardiovascular disease
- Peptic ulcer disease
- Psychiatric illness
- Failure of spinal anesthesia requiring conversion to general anesthesia
- BMI > 35 kg/m²
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
KRL Hospital, Islamabad
Islamabad, Federal Capital Territory, 44000
About this study
Official title: Effect of Single-Dose Administration of Dexamethasone on Postoperative Pain in Patients Undergoing Cesarean Section Under Spinal Anesthesia
This study looked at whether giving a single dose of dexamethasone (a steroid medicine, 8 mg given into the vein) before a cesarean section could reduce pain after the operation.
Eighty women having a planned cesarean section under spinal anesthesia at KRL Hospital, Islamabad were divided into two equal groups by chance. One group received dexamethasone through a drip before the procedure; the other group received a harmless salt-water solution (normal saline) as a comparison.
Read more
Pain levels were measured using a 0-10 pain scale at 2, 6, 12, and 24 hours after surgery. The study also recorded how long it took before patients needed an extra painkiller.
The group that received dexamethasone reported significantly less pain at 6, 12, and 24 hours after surgery, and far fewer patients in that group needed additional pain relief (7.5% vs 65%). The drug was well tolerated with no major side effects.
The findings suggest that a single pre-operative dose of dexamethasone is a simple and effective way to improve pain control after cesarean section.
Read the detailed description
Postoperative pain following lower segment cesarean section (LSCS) remains a significant clinical concern, particularly as spinal anesthesia wears off within the first few post-operative hours. Dexamethasone, a corticosteroid with known anti-inflammatory and analgesic properties, has been studied as an adjunct for postoperative pain control in various surgical settings.
This randomized controlled trial enrolled 80 ASA I-II patients aged 18-40 years undergoing elective LSCS under spinal anesthesia. Patients were randomized into two groups (n=40 each) using non-probability consecutive sampling. Group A received intravenous dexamethasone 8 mg (2 ml) prior to induction; Group B received intravenous normal saline 0.9% (2 ml) as placebo. Standard spinal anesthesia was administered to all participants.
Pain intensity was assessed using the Visual Analogue Scale (VAS, 0-10) at 2, 6, 12, and 24 hours postoperatively. Rescue analgesia was administered when VAS exceeded 4. Time to first rescue analgesia was recorded as a secondary outcome.
- Conditions
- Spinal Anesthesia, Cesarean Section Pain, Postoperative Pain
- Being tested
- Dexamethasone (IV), Normal Saline 0.9% Infusion Solution
- Keywords
- Dexamethasone, Postoperative analgesia, Lower segment cesarean section, Spinal anesthesia, Rescue analgesia, Corticosteroid, Cesarean Section
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexamethasone (IV)Drug
Also called Decadron, Dexamethasone Sodium Phosphate
Single intravenous dose of dexamethasone 8 mg (2 ml) administered prior to induction of spinal anesthesia. Applied to: Dexamethasone Group (Arm 1).
Normal Saline 0.9% Infusion SolutionDrug
Also called Sodium Chloride 0.9%
Single intravenous dose of normal saline 0.9% (2 ml) administered prior to induction of spinal anesthesia, serving as placebo control. Applied to: Placebo Group (Arm 2).
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone Group | Experimental | Participants received a single intravenous dose of dexamethasone 8 mg (2 ml) prior to spinal anesthesia for elective lower segment cesarean section. Standard spinal anesthesia was administered to all participants. Postoperative pain was assessed using VAS at 2, 6, 12, and 24 hours. Receives: Drug: Dexamethasone (IV) |
| Placebo Group | Placebo comparator | Participants received a single intravenous dose of normal saline 0.9% (2 ml) prior to spinal anesthesia for elective lower segment cesarean section. Standard spinal anesthesia was administered to all participants. Postoperative pain was assessed using VAS at 2, 6, 12, and 24 hours. Receives: Drug: Normal Saline 0.9% Infusion Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity
Pain intensity measured using the Visual Analogue Scale (VAS, 0-10; 0 = no pain, 10 = worst pain) at 2, 6, 12, and 24 hours after surgery.
Measured: 2, 6, 12, and 24 hours postoperatively
Secondary outcomes (2)
Time to First Rescue Analgesia
Time elapsed (in hours) from end of surgery to first administration of rescue analgesia, given when VAS score exceeded 4.
Measured: Within 24 hours postoperatively
Proportion of Patients Requiring Rescue Analgesia
Number of participants in each group who required at least one dose of rescue analgesia within 24 hours of surgery.
Measured: Within 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start1 Mar 2024
- Primary completion1 Sep 2024
- Study completion1 Sep 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- KRL Hospital, Islamabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Komal Shahid, KRL Hospital, Islamabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07718360
- Sponsor's protocol ID
- 23011995
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2026
- Last updated
- 21 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect patient confidentiality and privacy, in accordance with the ethical approval conditions of the Institutional Review Board, KRL Hospital Islamabad.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Single-Dose Administration of Dexamethasone on Postoperative Pain in Patients Undergoing Cesarean Section Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT07718360
- Acronym / sponsor ID
- 23011995
- Conditions
- Spinal Anesthesia, Cesarean Section Pain, Postoperative Pain
- Keywords
- Dexamethasone, Postoperative analgesia, Lower segment cesarean section, Spinal anesthesia, Rescue analgesia, Corticosteroid, Cesarean Section
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- KRL Hospital, IslamabadUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 21 Jul 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.
This study looked at whether giving a single dose of dexamethasone (a steroid medicine, 8 mg given into the vein) before a cesarean section could reduce pain after the operation.
Eighty women having a planned cesarean section under spinal anesthesia at KRL Hospital, Islamabad were divided into two equal groups by chance. One group received dexamethasone through a drip before the procedure; the other group received a harmless salt-water solution (normal saline) as a comparison.
Pain levels were measured using a 0-10 pain scale at 2, 6, 12, and 24 hours after surgery. The study also recorded how long it took before patients needed an extra painkiller.
The group that received dexamethasone reported significantly less pain at 6, 12, and 24 hours after surgery, and far fewer patients in that group needed additional pain relief (7.5% vs 65%). The drug was well tolerated with no major side effects.
The findings suggest that a single pre-operative dose of dexamethasone is a simple and effective way to improve pain control after cesarean section.
Detailed description
Postoperative pain following lower segment cesarean section (LSCS) remains a significant clinical concern, particularly as spinal anesthesia wears off within the first few post-operative hours. Dexamethasone, a corticosteroid with known anti-inflammatory and analgesic properties, has been studied as an adjunct for postoperative pain control in various surgical settings.
This randomized controlled trial enrolled 80 ASA I-II patients aged 18-40 years undergoing elective LSCS under spinal anesthesia. Patients were randomized into two groups (n=40 each) using non-probability consecutive sampling. Group A received intravenous dexamethasone 8 mg (2 ml) prior to induction; Group B received intravenous normal saline 0.9% (2 ml) as placebo. Standard spinal anesthesia was administered to all participants.
Pain intensity was assessed using the Visual Analogue Scale (VAS, 0-10) at 2, 6, 12, and 24 hours postoperatively. Rescue analgesia was administered when VAS exceeded 4. Time to first rescue analgesia was recorded as a secondary outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone Group | Experimental | Drug: Dexamethasone (IV)Participants received a single intravenous dose of dexamethasone 8 mg (2 ml) prior to spinal anesthesia for elective lower segment cesarean section. Standard spinal anesthesia was administered to all participants. Postoperative pain was assessed using VAS at 2, 6, 12, and 24 hours. |
| Placebo Group | Placebo comparator | Drug: Normal Saline 0.9% Infusion SolutionParticipants received a single intravenous dose of normal saline 0.9% (2 ml) prior to spinal anesthesia for elective lower segment cesarean section. Standard spinal anesthesia was administered to all participants. Postoperative pain was assessed using VAS at 2, 6, 12, and 24 hours. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female patients aged 18-40 years
- Scheduled for elective lower segment cesarean section (LSCS)
- Spinal anesthesia planned and suitable
- ASA physical status Class I or II
- Gestational age ≥ 37 weeks
Key exclusion criteria (11 listed)
- Known allergy or hypersensitivity to dexamethasone or any corticosteroid
- Diabetes mellitus or uncontrolled hyperglycemia
- Current or recent (within 4 weeks) corticosteroid use
- Contraindication to spinal anesthesia (coagulopathy, infection at puncture site, patient refusal)
- Emergency cesarean section
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 |
|---|---|---|
| Dexamethasone (IV)Also: Decadron, Dexamethasone Sodium PhosphateSingle intravenous dose of dexamethasone 8 mg (2 ml) administered prior to induction of spinal anesthesia. Applied to: Dexamethasone Group (Arm 1). | Drug | Dexamethasone Group |
| Normal Saline 0.9% Infusion SolutionAlso: Sodium Chloride 0.9%Single intravenous dose of normal saline 0.9% (2 ml) administered prior to induction of spinal anesthesia, serving as placebo control. Applied to: Placebo Group (Arm 2). | Drug | Placebo Group |
Primary outcome
Postoperative Pain Intensity
Time frame: 2, 6, 12, and 24 hours postoperatively
Pain intensity measured using the Visual Analogue Scale (VAS, 0-10; 0 = no pain, 10 = worst pain) at 2, 6, 12, and 24 hours after surgery.
2 secondary outcomes
Time to First Rescue Analgesia
Time frame: Within 24 hours postoperatively
Proportion of Patients Requiring Rescue Analgesia
Time frame: Within 24 hours postoperatively
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 21 Jul 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect patient confidentiality and privacy, in accordance with the ethical approval conditions of the Institutional Review Board, KRL Hospital Islamabad.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 (IV) and Normal Saline 0.9% Infusion Solution in people with Spinal Anesthesia and Cesarean Section Pain, run by KRL Hospital, Islamabad 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 6 inclusion and 11 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 21 Jul 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 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?
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?
Postoperative Pain Intensity (time frame: 2, 6, 12, and 24 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 21 Jul 2026.