Postoperative PainPhase 2NCT03612947
TAP Block in Laparoscopic Cholecystectomy.
A Phase 2 study testing Bupivacaine +magnesium sulphate and Bupivacaine only in people with Postoperative Pain, run by Assiut University at 1 site in Egypt.
Trial summary
Ultrasound-guided transversus abdominis plane block is now widely used in abdominal surgery. Recently, magnesium sulphate is used as adjuvant to local anesthetics. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Bupivacaine +magnesium sulphate and Bupivacaine only
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Sep 2018to 15 Dec 2019
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (age: 18-65 years old) undergoing laparoscopic cholecystectomy.
Who cannot join
- Patient refusal
- Patients with a history of cardiac, or respiratory diseases ( >ASA III).
- Patients with allergy to amide local anesthetics or medication included in the study.
- Infection at the needle insertion site.
- Pregnancy
- BMI >35
- Drug abusers
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Medicine Assuit University
Asyut, Asyut Governorate, 71516
About this study
Official title: Effect of Magnesium Sulfate When Added to TAP Block With Bupivacaine in Patients Undergoing Laparoscopic Cholecystectomy.
Ultrasound-guided transversus abdominis plane block is now widely used in abdominal surgery. Recently, magnesium sulphate is used as adjuvant to local anesthetics.
Read the detailed description
A significant pain experienced by patients after laparoscopic cholecystectomy surgery is required so as to block nociceptive transmission from both the abdominal wall incision, and visceral sites.
Using of opioids can result in significant adverse effects, thus delaying early mobilization of patients.
Ultrasound-guided transversus abdominis plane (TAP) block has been used as a satisfactory approach that provides postoperative analgesia. TAP block is safe; it diminishes or replaces the use of opioids; and it has a lower incidence of adverse effects.
Bupivacaine is a medication used to decrease feeling in a specific area. It is used by injecting it into the area, around a nerve that supplies the area, or into the spinal canal's epidural space. Bupivacaine is indicated for local infiltration, peripheral nerve block, sympathetic nerve block, and epidural and caudal blocks.
Magnesium is the fourth most plentiful cation in our body. It may be worthwhile to further study the role of supplemental magnesium in providing perioperative analgesia, because this is a relatively harmless molecule, is not expensive and also because the biological basis for its potential antinociceptive effect is promising.
Magnesium sulphate (MgSO4), N-methyl-D-aspartate receptor antagonist has the potential to be an ideal adjuvant in TAP block.
- Conditions
- Postoperative Pain
- Being tested
- Bupivacaine +magnesium sulphate, Bupivacaine only
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine +magnesium sulphateDrug
Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine) plus 150 mg of MgSo4
Bupivacaine onlyDrug
Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine).
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine +magnesium sulphate | Active comparator | Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine) plus 150 mg of MgSo4. Receives: Drug: Bupivacaine +magnesium sulphate |
| Bupivacaine only | Placebo comparator | Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine). Receives: Drug: Bupivacaine only |
What is being measured
The primary outcome is the main question the study is designed to answer.
The postoperative pain
Visual analogue pain score ranging from 0-10 cm where 0 cm
= no pain and 10 cm = the worst imaginable pain.
Measured: The first 24 hours after surgery
Secondary outcomes (4)
Time to first dose of post-operative analgesia
hours
Measured: First occurrence during hospitalization (up to 24 hours postoperatively)
Postoperative nausea and vomiting
A three-point rating scale (1: no postoperative nausea and vomiting, 2: nausea without vomiting, 3: nausea with vomiting).
Measured: The first 24 hours after surgery
postoperative sedation
Ramsay sedation score as follows: (1) anxious and irritable or dysphoric or both; (2) co-operational, oriented and quiet; (3) responsive to command; (4) asleep, quickly responsive to light tap or loud auditory stimulus; (5) asleep, slowly responsive to light tap or loud auditory stimulus; and (6) asleep, no response to light tap or loud auditory stimulus.
Measured: The first 24 hours after surgery
Patient satisfaction
Patient satisfaction score ranged from 0-100 points; with 0 indicating the worst level of satisfaction and 100 indicating the best level of satisfaction.
Measured: At 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start3 Sep 2018
- Primary completion15 Dec 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seham Mohamed Moeen Ibrahim, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612947
- Sponsor's protocol ID
- 52018
- Status last verified
- Dec 2019
- First submitted
- 19 Jul 2018
- Last updated
- 26 Dec 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 26 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Magnesium Sulfate When Added to TAP Block With Bupivacaine in Patients Undergoing Laparoscopic Cholecystectomy.
- ClinicalTrials.gov ID
- NCT03612947
- Acronym / sponsor ID
- 52018
- Conditions
- Postoperative Pain
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 3 Sep 2018 (actual)
- Primary completion
- 15 Dec 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 2 Aug 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.
Ultrasound-guided transversus abdominis plane block is now widely used in abdominal surgery. Recently, magnesium sulphate is used as adjuvant to local anesthetics.
Detailed description
A significant pain experienced by patients after laparoscopic cholecystectomy surgery is required so as to block nociceptive transmission from both the abdominal wall incision, and visceral sites.
Using of opioids can result in significant adverse effects, thus delaying early mobilization of patients.
Ultrasound-guided transversus abdominis plane (TAP) block has been used as a satisfactory approach that provides postoperative analgesia. TAP block is safe; it diminishes or replaces the use of opioids; and it has a lower incidence of adverse effects.
Bupivacaine is a medication used to decrease feeling in a specific area. It is used by injecting it into the area, around a nerve that supplies the area, or into the spinal canal's epidural space. Bupivacaine is indicated for local infiltration, peripheral nerve block, sympathetic nerve block, and epidural and caudal blocks.
Magnesium is the fourth most plentiful cation in our body. It may be worthwhile to further study the role of supplemental magnesium in providing perioperative analgesia, because this is a relatively harmless molecule, is not expensive and also because the biological basis for its potential antinociceptive effect is promising.
Magnesium sulphate (MgSO4), N-methyl-D-aspartate receptor antagonist has the potential to be an ideal adjuvant in TAP block.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine +magnesium sulphate | Active comparator | Drug: Bupivacaine +magnesium sulphateUltrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine) plus 150 mg of MgSo4. |
| Bupivacaine only | Placebo comparator | Drug: Bupivacaine onlyUltrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (age: 18-65 years old) undergoing laparoscopic cholecystectomy.
Key exclusion criteria (7 listed)
- Patient refusal
- Patients with a history of cardiac, or respiratory diseases ( >ASA III).
- Patients with allergy to amide local anesthetics or medication included in the study.
- Infection at the needle insertion site.
- Pregnancy
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 +magnesium sulphateUltrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine) plus 150 mg of MgSo4 | Drug | Bupivacaine +magnesium sulphate |
| Bupivacaine onlyUltrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine). | Drug | Bupivacaine only |
Primary outcome
The postoperative pain
Time frame: The first 24 hours after surgery
Visual analogue pain score ranging from 0-10 cm where 0 cm = no pain and 10 cm = the worst imaginable pain.
4 secondary outcomes
Time to first dose of post-operative analgesia
Time frame: First occurrence during hospitalization (up to 24 hours postoperatively)
Postoperative nausea and vomiting
Time frame: The first 24 hours after surgery
postoperative sedation
Time frame: The first 24 hours after surgery
Patient satisfaction
Time frame: At 24 hours after surgery
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 26 Dec 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 2 study testing Bupivacaine +magnesium sulphate and Bupivacaine only in people with Postoperative 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 1 inclusion and 7 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 26 Dec 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. 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 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?
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?
The postoperative pain (time frame: The first 24 hours after surgery). 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 Dec 2019.