Post Operative Pain, AcutePhase 2NCT05186467
Pain After Laparoscopy Results From the Incision, Manipulation of the Abdominal Organs, and Retained CO2(Back Pain)
A Phase 2 study testing intraperitoneal Magnesium sulfate and intravenous magnesium sulfate in people with Post Operative Pain, Acute, run by Sohag University at 1 site in Egypt.
Trial summary
Postoperative pain after laparoscopy may be localized pain resulting from incision due to many (two or three) punctures (somatic pain) or due to manipulation of the intra-abdominal organs as ovaries, uterus, omentum, and intestine (visceral pain) or shoulder and back pain caused by retained CO2 in the peritoneal… Read more about this study
- Who is it for?
- Ages 20 to 44 years, women only
- Conditions the study is for
- Post Operative Pain, Acute
- What is being tested?
- intraperitoneal Magnesium sulfate and intravenous magnesium sulfate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Sep 2021to 5 Feb 2022
- Phase
- Phase 2
- 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 20 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 20-44 years old females, (ASA) class I-II
Who cannot join
- Patient refusal
- Allergy to MgSO4
- Atrio-ventricular conduction abnormalities
- Drug abuse
- Renal or hepatic or cardiovascular dysfunction
- Prior long-term treatment with calcium channel blockers or magnesium
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Fouad Soliman
Sohag, 52514
Fouad Soliman, 01113815186, fouad_soliman@med.sohag.edu.eg
About this study
Official title: Comparing the Analgesic Effect of Intraperitoneal and Intravenous Magnesium Sulphate in Diagnostic Gynecological Laparoscopy
Postoperative pain after laparoscopy may be localized pain resulting from incision due to many (two or three) punctures (somatic pain) or due to manipulation of the intra-abdominal organs as ovaries, uterus, omentum, and intestine (visceral pain) or shoulder and back pain caused by retained CO2 in the peritoneal cavity with its irritation effect on the diaphragm.Patients will be divided into two groups:
Intraperitoneal (IP) group (20 patients):They will receive 100 ml normal saline infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline intraoperatively then intraperitoneal wash of 100 ml normal saline containing 30 mg/kg MgSO4 at the end of laparoscopy.
Intravenous (IV) group (20 patients):They will receive 100 ml normal saline containing MgSO4 30 mg/kg infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline containing MgSO4 (8mg/kg) intraoperatively then intraperitoneal wash using 100 ml normal saline at the end of laparoscopy
- Conditions
- Post Operative Pain, Acute
- Being tested
- intraperitoneal Magnesium sulfate, intravenous magnesium sulfate
- Keywords
- mgso4,laparoscopy ,intraperitoneal
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intraperitoneal Magnesium sulfateDrug
Intraperitoneal (IP) group will receive 100 ml normal saline infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline intraoperatively then intraperitoneal wash of 100 ml normal saline containing 30 mg/kg MgSO4 at the end of laparoscopy.
intravenous magnesium sulfateDrug
Intravenous (IV) group will receive 100 ml normal saline containing MgSO4 30 mg/kg infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline containing MgSO4 (8mg/kg) intraoperatively then intraperitoneal wash using 100 ml normal saline at the end of laparoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Intraperitoneal magnesium sulfate (IP) group | Active comparator | They will receive 100 ml normal saline infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline intraoperatively then an intraperitoneal wash of 100 ml normal saline containing 30 mg/kg MgSO4 at the end of laparoscopy. Receives: Drug: intraperitoneal Magnesium sulfate |
| Intravenous magnesium sulfate (IV) group | Active comparator | They will receive 100 ml normal saline containing MgSO4 30 mg/kg infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline containing MgSO4 (8mg/kg) intraoperatively then intraperitoneal wash using 100 ml normal saline at the end of laparoscopy. Receives: Drug: intravenous magnesium sulfate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time for first dose of rescue analgesia
1st time to feel pain
Measured: 8 hours
total analgesic doses
total (ketorolac) analgesic consumption
Measured: 8 hours
Secondary outcomes (4)
post operative pain
The visual analog scale(0-10 with 0 is no pain and 10 is maximum intolerable pain)
Measured: 8 hours
sedation
4 points sedation scale: 0= alert and conscious
1 =quietly awake 2= asleep but easily arousable 3= deep sleep
Measured: 8 hours
adverse events
side effects
Measured: 8 hours
serum mgso4 level
serum level of mgso4 at end of operation and after 2 hours
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start2 Sep 2021
- Primary completion2 Feb 2022 (estimated)
- Study completion5 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Sohag 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 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fouad Soliman, Sohag University
- Investigators
- Fouad Soliman, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05186467
- Sponsor's protocol ID
- 2007
- Status last verified
- Jan 2022
- First submitted
- 29 Dec 2021
- Last updated
- 26 Jan 2022
- 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 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Analgesic Effect of Intraperitoneal and Intravenous Magnesium Sulphate in Diagnostic Gynecological Laparoscopy
- ClinicalTrials.gov ID
- NCT05186467
- Acronym / sponsor ID
- 2007
- Conditions
- Post Operative Pain, Acute
- Keywords
- mgso4,laparoscopy ,intraperitoneal
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 2 Feb 2022 (estimated)
- Study completion
- 5 Feb 2022 (estimated)
- First posted
- 11 Jan 2022 (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.
Postoperative pain after laparoscopy may be localized pain resulting from incision due to many (two or three) punctures (somatic pain) or due to manipulation of the intra-abdominal organs as ovaries, uterus, omentum, and intestine (visceral pain) or shoulder and back pain caused by retained CO2 in the peritoneal cavity with its irritation effect on the diaphragm.Patients will be divided into two groups:
Intraperitoneal (IP) group (20 patients):They will receive 100 ml normal saline infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline intraoperatively then intraperitoneal wash of 100 ml normal saline containing 30 mg/kg MgSO4 at the end of laparoscopy.
Intravenous (IV) group (20 patients):They will receive 100 ml normal saline containing MgSO4 30 mg/kg infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline containing MgSO4 (8mg/kg) intraoperatively then intraperitoneal wash using 100 ml normal saline at the end of laparoscopy
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intraperitoneal magnesium sulfate (IP) group | Active comparator | Drug: intraperitoneal Magnesium sulfateThey will receive 100 ml normal saline infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline intraoperatively then an intraperitoneal wash of 100 ml normal saline containing 30 mg/kg MgSO4 at the end of laparoscopy. |
| Intravenous magnesium sulfate (IV) group | Active comparator | Drug: intravenous magnesium sulfateThey will receive 100 ml normal saline containing MgSO4 30 mg/kg infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline containing MgSO4 (8mg/kg) intraoperatively then intraperitoneal wash using 100 ml normal saline at the end of laparoscopy. |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 20-44 years old females, (ASA) class I-II
Key exclusion criteria (6 listed)
- Patient refusal
- Allergy to MgSO4
- Atrio-ventricular conduction abnormalities
- Drug abuse
- Renal or hepatic or cardiovascular dysfunction
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 |
|---|---|---|
| intraperitoneal Magnesium sulfateIntraperitoneal (IP) group will receive 100 ml normal saline infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline intraoperatively then intraperitoneal wash of 100 ml normal saline containing 30 mg/kg MgSO4 at the end of laparoscopy. | Drug | Intraperitoneal magnesium sulfate (IP) group |
| intravenous magnesium sulfateIntravenous (IV) group will receive 100 ml normal saline containing MgSO4 30 mg/kg infused over 10 min immediately before the induction of anesthesia and then continuous infusion of 500 ml normal saline containing MgSO4 (8mg/kg) intraoperatively then intraperitoneal wash using 100 ml normal saline at the end of laparoscopy. | Drug | Intravenous magnesium sulfate (IV) group |
Primary outcome
Time for first dose of rescue analgesia
Time frame: 8 hours
1st time to feel pain
total analgesic doses
Time frame: 8 hours
total (ketorolac) analgesic consumption
4 secondary outcomes
post operative pain
Time frame: 8 hours
sedation
Time frame: 8 hours
adverse events
Time frame: 8 hours
serum mgso4 level
Time frame: 2 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
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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.
Fouad Soliman principal investigator
Sohag University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing intraperitoneal Magnesium sulfate and intravenous magnesium sulfate in people with Post Operative Pain, Acute, run by Sohag 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 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: status not confirmed, as of the sponsor's last update on 26 Jan 2022. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fouad Soliman, lecturer (01113815186, fouad_soliman@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time for first dose of rescue analgesia (time frame: 8 hours). The study lists 2 primary outcomes in all. 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 26 Jan 2022.