Postoperative PainPhase 4NCT02784340
Local and Intravenous Dexamethasone on Post Operative Pain a After CS
A Phase 4 study testing Dexamethasone, Saline (IV fluids) and Bupivicaine and Fentany in people with Postoperative Pain, run by Cairo University.
Trial summary
A Prospective, randomized study conducted on 120 pregnant women attending the labour wards in Kasr Al Ainy and Fayoum maternity hospitals from May 2014 to December 2015. All participants were scheduled for elective cesarean section under spinal anaesthesia and were randomly divided into 3 equal groups. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Dexamethasone, Saline (IV fluids) and Bupivicaine and Fentany
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Dec 2015
- 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 19 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All participants were scheduled for elective cesarean section under spinal anaesthesia
Who cannot join
- Women with neurological disorders
- Psychologically disturbed
- Those with uncontrolled hypertension, Diabetes Mellitus, peptic ulcer, liver cirrhosis or glaucoma
- Women with systemic infections
- Allergy to Dexamethasone
- Contraindications to spinal anaesthesia
About this study
Official title: Comparison of Local and Intra Venous Dexamethasone on Post Operative Pain and Recovery After Caeseream Section
A Prospective, randomized study conducted on 120 pregnant women attending the labour wards in Kasr Al Ainy and Fayoum maternity hospitals from May 2014 to December 2015. All participants were scheduled for elective cesarean section under spinal anaesthesia and were randomly divided into 3 equal groups. Group 1(40 women) received 16 mg Dexamethasone IV drip. Group II (40 women) received 16 mg Dexamethasone subcutaneous injection around the caesarean section scar after skin closure and Group III received Placebo in the form of IV fluids 500 cc saline infusion. All cases were followed up for 48 hours for assessment of level of pain by using a 10-cm visual analog scale (VAS). Primary outcome parameters were VAS score and the need for additional analgesics. Other parameters were hemodynamic changes and occurrence of side effects or complications
Read the detailed description
The patients were subjected to history taking, including age, parity, menstrual history for verification of gestational age and medical history for confirmation of inclusion and exclusion criteria. Full general and abdominal and obstetric examinations were done. Investigations including complete blood picture, liver functions and coagulation profile to exclude those not fitting with the above listed criteria. Ultrasound was done to assess gestational age.
Patients were checked for coagulation abnormalities. Large gauge (18G) cannula was inserted in cephalic or ante cubital veins. Patients were preloaded with HAES- steril 6% (hydroxyl ethyl starch) Fresenius. Or, preloaded with ringer's lactate 20 ml/kg. Patients were positioned in the sitting position for spinal anaesthesia and sterilization of the back was done using Betadine. L3-L4 space was determined for the insertion of spinal needle. Then 25G spinal needle was used to perform a single shot spinal anaesthesia using 10mg of 0.5% hyperbaric Bupivicaine and Fentanyl 20 micrograms.
All surgeons had close surgical skills and used the same technique transverse lower segment incision.
The procedure is then completed using traction on cord to deliver the placenta, exteriorization of uterus, closure of uterine incision in 2 layers, closure of both visceral and parietal peritoneum, closure of rectus sheath, no subcutaneous closure and finally subcuticular skin closure. Follow up for all cases for 48 hours. Primary outcome parameters were VAS score and the need for additional analgesics. Other parameters were hemodynamic changes and occurrence of side effects or complications.
- Conditions
- Postoperative Pain
- Being tested
- Dexamethasone, Saline (IV fluids), Bupivicaine and Fentany, 25G spinal needles
- Keywords
- Postoperative pain, dexamethasone, 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.
DexamethasoneDrug
Also called dexamethasone sodium phosphate. EIPICO pharmaceutical, Egypt
16 mg Dexamethasone IV drip
DexamethasoneDrug
Also called dexamethasone sodium phosphate USP 8mg/2ml amp. EIPICO pharmaceutical, Egypt
16 mg Dexamethasone subcutaneous injection around the caesarean section scar after skin closure
Saline (IV fluids)Drug
Also called saline infusion
IV fluids 500 cc saline infusion
Bupivicaine and FentanyDrug
25G spinal needlesDevice
| Study group | Role | What they receive |
|---|---|---|
| IV dexamethasone | Active comparator | 40 women received 16 mg Dexamethasone IV drip. Receives: Drug: Dexamethasone; Drug: Bupivicaine and Fentany; Device: 25G spinal needles |
| Local dexamethasone | Active comparator | 40 women received 16 mg Dexamethasone subcutaneous injection around the caesarean section scar after skin closure Receives: Drug: Dexamethasone; Drug: Bupivicaine and Fentany; Device: 25G spinal needles |
| placebo | Placebo comparator | Placebo in the form of IV fluids 500 cc saline infusion Receives: Drug: Saline (IV fluids); Drug: Bupivicaine and Fentany; Device: 25G spinal needles |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score visual acoustic score
Subjective description of the pain using questionaire
Measured: 48 hours after CS
Secondary outcomes (2)
need for additional analgesics
Measured: 48 hours after CS
Blood pressure
Measured: 48 hours after CS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startMay 2014
- Primary completionDec 2015
- Study completionDec 2015
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 Postoperative PainStudies of the same condition, open and under way.
- More trials run by Cairo 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed Maged, MD, Principal investigator, Kasr Alainy medical school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784340
- Sponsor's protocol ID
- 148
- Status last verified
- May 2016
- First submitted
- 20 May 2016
- Last updated
- 27 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Maged AM, Deeb WS, Elbaradie S, Elzayat AR, Metwally AA, Hamed M, Shaker A. Comparison of local and intra venous dexamethasone on post operative pain and recovery after caeseream section. A randomized controlled trial. Taiwan J Obstet Gynecol. 2018 Jun;57(3):346-350. doi: 10.1016/j.tjog.2018.04.004.
PubMed 29880162
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Local and Intra Venous Dexamethasone on Post Operative Pain and Recovery After Caeseream Section
- ClinicalTrials.gov ID
- NCT02784340
- Acronym / sponsor ID
- 148
- Conditions
- Postoperative Pain
- Keywords
- Postoperative pain, dexamethasone, cesarean section
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 27 May 2016 (estimated)
- 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.
A Prospective, randomized study conducted on 120 pregnant women attending the labour wards in Kasr Al Ainy and Fayoum maternity hospitals from May 2014 to December 2015. All participants were scheduled for elective cesarean section under spinal anaesthesia and were randomly divided into 3 equal groups. Group 1(40 women) received 16 mg Dexamethasone IV drip. Group II (40 women) received 16 mg Dexamethasone subcutaneous injection around the caesarean section scar after skin closure and Group III received Placebo in the form of IV fluids 500 cc saline infusion. All cases were followed up for 48 hours for assessment of level of pain by using a 10-cm visual analog scale (VAS). Primary outcome parameters were VAS score and the need for additional analgesics. Other parameters were hemodynamic changes and occurrence of side effects or complications
Detailed description
The patients were subjected to history taking, including age, parity, menstrual history for verification of gestational age and medical history for confirmation of inclusion and exclusion criteria. Full general and abdominal and obstetric examinations were done. Investigations including complete blood picture, liver functions and coagulation profile to exclude those not fitting with the above listed criteria. Ultrasound was done to assess gestational age.
Patients were checked for coagulation abnormalities. Large gauge (18G) cannula was inserted in cephalic or ante cubital veins. Patients were preloaded with HAES- steril 6% (hydroxyl ethyl starch) Fresenius. Or, preloaded with ringer's lactate 20 ml/kg. Patients were positioned in the sitting position for spinal anaesthesia and sterilization of the back was done using Betadine. L3-L4 space was determined for the insertion of spinal needle. Then 25G spinal needle was used to perform a single shot spinal anaesthesia using 10mg of 0.5% hyperbaric Bupivicaine and Fentanyl 20 micrograms.
All surgeons had close surgical skills and used the same technique transverse lower segment incision.
The procedure is then completed using traction on cord to deliver the placenta, exteriorization of uterus, closure of uterine incision in 2 layers, closure of both visceral and parietal peritoneum, closure of rectus sheath, no subcutaneous closure and finally subcuticular skin closure. Follow up for all cases for 48 hours. Primary outcome parameters were VAS score and the need for additional analgesics. Other parameters were hemodynamic changes and occurrence of side effects or complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| IV dexamethasone | Active comparator | Drug: Dexamethasone, Drug: Bupivicaine and Fentany, Device: 25G spinal needles40 women received 16 mg Dexamethasone IV drip. |
| Local dexamethasone | Active comparator | Drug: Dexamethasone, Drug: Bupivicaine and Fentany, Device: 25G spinal needles40 women received 16 mg Dexamethasone subcutaneous injection around the caesarean section scar after skin closure |
| placebo | Placebo comparator | Drug: Saline (IV fluids), Drug: Bupivicaine and Fentany, Device: 25G spinal needlesPlacebo in the form of IV fluids 500 cc saline infusion |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All participants were scheduled for elective cesarean section under spinal anaesthesia
Key exclusion criteria (6 listed)
- Women with neurological disorders
- Psychologically disturbed
- Those with uncontrolled hypertension, Diabetes Mellitus, peptic ulcer, liver cirrhosis or glaucoma
- Women with systemic infections
- Allergy to Dexamethasone
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 |
|---|---|---|
| DexamethasoneAlso: dexamethasone sodium phosphate. EIPICO pharmaceutical, Egypt16 mg Dexamethasone IV drip | Drug | IV dexamethasone |
| DexamethasoneAlso: dexamethasone sodium phosphate USP 8mg/2ml amp. EIPICO pharmaceutical, Egypt16 mg Dexamethasone subcutaneous injection around the caesarean section scar after skin closure | Drug | Local dexamethasone |
| Saline (IV fluids)Also: saline infusionIV fluids 500 cc saline infusion | Drug | placebo |
| Bupivicaine and Fentany | Drug | IV dexamethasone, Local dexamethasone, placebo |
| 25G spinal needles | Device | IV dexamethasone, Local dexamethasone, placebo |
Primary outcome
VAS score visual acoustic score
Time frame: 48 hours after CS
Subjective description of the pain using questionaire
2 secondary outcomes
need for additional analgesics
Time frame: 48 hours after CS
Blood pressure
Time frame: 48 hours after CS
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 27 May 2016.
- Derived from this study: PubMed 29880162Maged AM, Deeb WS, Elbaradie S, Elzayat AR, Metwally AA, Hamed M, Shaker A. Comparison of local and intra venous dexamethasone on post operative pain and recovery after caeseream section. A randomized controlled trial. Taiwan J Obstet Gynecol. 2018 Jun;57(3):346-350. doi: 10.1016/j.tjog.2018.04.004.
- 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. This study is not recruiting at the moment.
Ahmed Maged, MD principal investigator
Kasr Alainy medical school
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone, Saline (IV fluids) and Bupivicaine and Fentany in people with Postoperative Pain, run by Cairo 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 1 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 27 May 2016. 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. 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?
VAS score visual acoustic score (time frame: 48 hours after CS). 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 NCT02784340, 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 27 May 2016.