Intraoperativ PainNCT04779060
Intrathecal Fentanyle Versus Dexamethasone in Gynacological Laparoscopic Surgeries
A study testing intrathecal fentanyle, dexamethasone and saline in people with Intraoperativ Pain, run by Assiut University at 1 site in Egypt.
Trial summary
Laparoscopy was first introduced to the medical field of in the middle of the last century. It revolutionized the surgical interventions; it reduced the total medical expenditures and hastened postoperative recovery . Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Intraoperativ Pain
- What is being tested?
- intrathecal fentanyle, dexamethasone and saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2016to Sep 2020
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- ASA I, II
- elective gynacological laparoscopic surgery
Who cannot join
- patient refusal
- chronic kidney and hepatic diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intrathecal Fentanyle Versus Dexamethasone in Patients Under Going Gynacological Laparoscopic Surgeries
Laparoscopy was first introduced to the medical field of in the middle of the last century. It revolutionized the surgical interventions; it reduced the total medical expenditures and hastened postoperative recovery . General anaesthesia (GA) was considered the only anesthetic technique suitable for laparoscopic interventions, and several myths and facts prevented regional anaesthesia (RA) implementation. Respiratory and Cardiovascular impairment were the main aspects of concern which are thought to be best controlled by GA
- Conditions
- Intraoperativ Pain
- Being tested
- intrathecal fentanyle, dexamethasone, saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intrathecal fentanyleDrug
25 mic fentanyle added to heavy bupivacaine for spinal anesthesia
dexamethasoneDrug
8 mg dexamethasone give intrathecally for spinal anaesthesia
salineDrug
normal saline will be mixed with bupivacaine intrathecally
| Study group | Role | What they receive |
|---|---|---|
| fentanyle group | Active comparator | Not described Receives: Drug: intrathecal fentanyle |
| dexamethasone group | Active comparator | Not described Receives: Drug: dexamethasone |
| control group | Placebo comparator | Not described Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative pain
pain measured by VAS score =from 0 to 10 0-3 is mild pain 3-6 moderate pain 6-10 sever pain
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study startJul 2016
- Primary completionSep 2020
- Study completionSep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraoperativ PainStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasha Hamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779060
- Sponsor's protocol ID
- 13700331
- Status last verified
- Mar 2021
- First submitted
- 27 Feb 2021
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intrathecal Fentanyle Versus Dexamethasone in Patients Under Going Gynacological Laparoscopic Surgeries
- ClinicalTrials.gov ID
- NCT04779060
- Acronym / sponsor ID
- 13700331
- Conditions
- Intraoperativ Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Sep 2020 (actual)
- Study completion
- Sep 2020 (actual)
- First posted
- 3 Mar 2021 (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.
Laparoscopy was first introduced to the medical field of in the middle of the last century. It revolutionized the surgical interventions; it reduced the total medical expenditures and hastened postoperative recovery . General anaesthesia (GA) was considered the only anesthetic technique suitable for laparoscopic interventions, and several myths and facts prevented regional anaesthesia (RA) implementation. Respiratory and Cardiovascular impairment were the main aspects of concern which are thought to be best controlled by GA
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| fentanyle group | Active comparator | Drug: intrathecal fentanyle |
| dexamethasone group | Active comparator | Drug: dexamethasone |
| control group | Placebo comparator | Drug: saline |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA I, II
- elective gynacological laparoscopic surgery
Key exclusion criteria (2 listed)
- patient refusal
- chronic kidney and hepatic diseases
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 |
|---|---|---|
| intrathecal fentanyle25 mic fentanyle added to heavy bupivacaine for spinal anesthesia | Drug | fentanyle group |
| dexamethasone8 mg dexamethasone give intrathecally for spinal anaesthesia | Drug | dexamethasone group |
| salinenormal saline will be mixed with bupivacaine intrathecally | Drug | control group |
Primary outcome
intraoperative pain
Time frame: 60 minutes
pain measured by VAS score =from 0 to 10 0-3 is mild pain 3-6 moderate pain 6-10 sever pain
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 17 Mar 2021.
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 study testing intrathecal fentanyle, dexamethasone and saline in people with Intraoperativ Pain, run by Assiut 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 2 inclusion and 2 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 17 Mar 2021. 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?
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?
intraoperative pain (time frame: 60 minutes). 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 Mar 2021.