AnesthesiaPhase 4NCT03393572
Intraperitoneal Bupivacaine With Magnesium or Nalbuphine for Postoperative Pain Control in Laparoscopic Hysterectomy
A Phase 4 study testing Bupivacaine 0.25%, Magnesium sulphate. and nalbuphine in people with Anesthesia, run by Ain Shams University at 1 site in Egypt.
Trial summary
The purpose of this study is to compare between the addition of Mg sulphate or Nalbuphine to intraperitoneal bupivacaine installation in laparoscopic hysterectomy for postoperative pain control and their relative adverse effects. Read more about this study
- Who is it for?
- Ages 20 to 60 years, women only
- Conditions the study is for
- Anesthesia
- What is being tested?
- Bupivacaine 0.25%, Magnesium sulphate. and nalbuphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jan 2018to 15 Jun 2018
- 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 20 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- American Society of Anesthesiologists (ASA) physical status I and II
- scheduled for laparoscopic hysterectomy
Who cannot join
- ASA physical status more than II
- Obesity (body mass index higher than 30 kg/ m2)
- History of chronic opioids intake
- Known hypomagnesaemia or hypermagnesaemia
- Chronic alcoholism
- Heart block
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- Renal failure
- Patients with history of left ventricular failure
- Patients taking beta-blocking drugs
- Allergy to the study drugs
- if surgery changed to open hysterectomy,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraperitoneal Instillation of Bupivacaine With Either Magnesium Sulphate or Nalbuphine for Postoperative Pain Control in Laparoscopic Hysterectomy: a Prospective, Randomized, Double-blinded Trial.
The purpose of this study is to compare between the addition of Mg sulphate or Nalbuphine to intraperitoneal bupivacaine installation in laparoscopic hysterectomy for postoperative pain control and their relative adverse effects.
- Conditions
- Anesthesia
- Being tested
- Bupivacaine 0.25%, Magnesium sulphate., nalbuphine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine 0.25%Drug
Patients will receive 30 mL of intraperitoneal bupivacaine 0.25%
Magnesium sulphate.Drug
Patients will receive intraperitoneal 30 mg/kg of magnesium sulphate.
nalbuphineDrug
Also called opioid
Patients will receive intraperitoneal 5 mg nalbuphine
| Study group | Role | What they receive |
|---|---|---|
| Group BM | Active comparator | bupivacaine 0.25% plus magnesium sulphate. Receives: Drug: Bupivacaine 0.25%; Drug: Magnesium sulphate. |
| Group BN | Active comparator | bupivacaine 0.25% plus nalbuphine Receives: Drug: Bupivacaine 0.25%; Drug: nalbuphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rescue analgesia time
Time to first analgesia requirment(considering the extubation is the zero time)
Measured: First 24 hours postoperatively
Secondary outcomes (2)
Visual analogue scale [VAS]
Visual analogue scale [VAS] will be used to measure pain score at 30 min, 1, 2, 4, 6, 8, 10, 12 and 24 h after surgery. All the study patients will be instructed about the use of the VAS scale before induction of anesthesia (VAS score 0 cm = no pain, VAS score 10 cm = worst possible pain)
Measured: First 24 hours postoperatively
Total analgesic consumption
Intravenous diclofenac 75 mg will be given as rescue analgesic when VAS ≥ 4.Total diclofenac consumption will be recorded.
Measured: First 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 posted8 Jan 2018
- Study start3 Jan 2018
- Primary completion5 Jun 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Ahmed Khairy Elbeialy, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03393572
- Sponsor's protocol ID
- FMASU R49/2017
- Status last verified
- Jul 2019
- First submitted
- 3 Jan 2018
- Last updated
- 16 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraperitoneal Instillation of Bupivacaine With Either Magnesium Sulphate or Nalbuphine for Postoperative Pain Control in Laparoscopic Hysterectomy: a Prospective, Randomized, Double-blinded Trial.
- ClinicalTrials.gov ID
- NCT03393572
- Acronym / sponsor ID
- FMASU R49/2017
- Conditions
- Anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 3 Jan 2018 (actual)
- Primary completion
- 5 Jun 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 8 Jan 2018 (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.
The purpose of this study is to compare between the addition of Mg sulphate or Nalbuphine to intraperitoneal bupivacaine installation in laparoscopic hysterectomy for postoperative pain control and their relative adverse effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group BM | Active comparator | Drug: Bupivacaine 0.25%, Drug: Magnesium sulphate.bupivacaine 0.25% plus magnesium sulphate. |
| Group BN | Active comparator | Drug: Bupivacaine 0.25%, Drug: nalbuphinebupivacaine 0.25% plus nalbuphine |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists (ASA) physical status I and II
- scheduled for laparoscopic hysterectomy
Key exclusion criteria (11 listed)
- ASA physical status more than II
- Obesity (body mass index higher than 30 kg/ m2)
- History of chronic opioids intake
- Known hypomagnesaemia or hypermagnesaemia
- Chronic alcoholism
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 |
|---|---|---|
| Bupivacaine 0.25%Patients will receive 30 mL of intraperitoneal bupivacaine 0.25% | Drug | Group BM, Group BN |
| Magnesium sulphate.Patients will receive intraperitoneal 30 mg/kg of magnesium sulphate. | Drug | Group BM |
| nalbuphineAlso: opioidPatients will receive intraperitoneal 5 mg nalbuphine | Drug | Group BN |
Primary outcome
Rescue analgesia time
Time frame: First 24 hours postoperatively
Time to first analgesia requirment(considering the extubation is the zero time)
2 secondary outcomes
Visual analogue scale [VAS]
Time frame: First 24 hours postoperatively
Total analgesic consumption
Time frame: First 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 16 Jul 2019.
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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 Bupivacaine 0.25%, Magnesium sulphate. and nalbuphine in people with Anesthesia, run by Ain Shams 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 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 16 Jul 2019. 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 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?
Rescue analgesia time (time frame: First 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 16 Jul 2019.