Postoperative Pain ManagementPhase 2/3NCT06148168
Magnesium Sulphate in Oblique Subcostal TAP Block
A Phase 2/3 study testing Bupivacaine plus normal saline and Bupivacaine plus normal saline containing MgSO4 in people with Postoperative Pain Management, run by Assiut University.
Trial summary
The aim of this study is to evaluate the effect of adding different doses of MgSO4 to bupivacaine via OSCTAB block on postoperative pain control for 24 hours in patients scheduled for LC. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Postoperative Pain Management
- What is being tested?
- Bupivacaine plus normal saline and Bupivacaine plus normal saline containing MgSO4
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2024to 20 Feb 2025
- Phase
- Phase 2/3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- • Patients programmed for elective LC.
- American society of anesthesiologists (ASA) physical state I or II.
- Age over 18 years and less than 60 years old.
- Patients of both sex are included in the study.
Who cannot join
- • Patient refusal.
- Known hypersensitivity to the study drugs.
- Body Mass Index > 40 kg/m2.
- Inability to accurately describe postoperative pain to investigators.
- Opioid tolerance or dependence.
- Preexisting history of chronic pain.
- History of renal, liver, cardiac, neuropsychiatric disorder problems.
- Bleeding or coagulation abnormality.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparative Evaluation of Different Doses of Magnesium Sulphate in Oblique Subcostal TAP Block for Laparoscopic Cholecystectomy: a Randomized Double-blind Controlled Study
The aim of this study is to evaluate the effect of adding different doses of MgSO4 to bupivacaine via OSCTAB block on postoperative pain control for 24 hours in patients scheduled for LC.
Read the detailed description
Laparoscopic cholecystectomy (LC) is a gold standard for management of gallbladder stones. Early and easily recovery, less operative morbidities, less postoperative pain, improved cosmetics, less hospitalization days and decreased cost are the superiorities of laparoscopic cholecystectomies over open surgical procedures.
Postoperative pain is the major obstacle for early postoperative ambulation and prolongs the hospital stay. Moreover, it has been hypothesized that intense acute pain after LC may predict development of chronic pain (e.g., post laparoscopic cholecystectomy syndrome). So, aggressive perioperative pain prevention is mandatory.
This pain is routinely managed using opiates, which has several side effects. Transversus abdominis plane (TAP) block is a regional anesthetic technique that has gradually become an alternative for postoperative pain control during laparoscopic abdominal surgeries. It involves the infusion of local anesthetic into the fascial plane of the abdominal wall. Oblique subcostal transversus abdominis plane (OSCTAP) block is an US-guided regional anesthesia technique that anesthetizes the nerves of the lower and upper anterior abdominal wall, specifically from T6 to L1.
Rafi et al and McDonnell et al were the first to describe (OSCTAP) block. They described an anatomical landmark technique and provided evidence of blockade to the mid/lower thoracic and upper lumbar spinal nerves as they travelled in the fascial plane between the transversus abdominis (TA) and internal oblique (IO) muscles.
Evidence supporting the presence of (NMDA) receptors in skin and muscles have led to the use of (MgSO4) which is NMDA antagonist via different routes.
- Conditions
- Postoperative Pain Management
- Being tested
- Bupivacaine plus normal saline, Bupivacaine plus normal saline containing MgSO4
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine plus normal salineDrug
Unlike specific peripheral nerve blocks, TAP block is a non-dermatomal "field block". Even with the same US-guided technique, the extent of spread of local anesthetics can be variable due to individual anatomical variations (18). In order to perform the blocks, abdominal skin will be prepared and covered with sterile drapes. The needle can be introduced by multiple punctures along the oblique subcostal line from the xiphoid process towards the anterior part of the iliac crest .Thus, LA will be injected in the TAP along this line provides both upper and lower abdominal wall analgesia. The OSCTAP block more consistently covers L1 dermatome. After negative aspiration, a test injection with 1 ml of 0.9% normal saline will be performed to confirm the needle location. If the intended sensation will not decreased in surgical dermatomes after 30 min, the patient will be regarded to have a failed block and will be excluded from the study.
Bupivacaine plus normal saline containing MgSO4Drug
Bupivacaine plus normal saline containing MgSO4
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | 24 patients will receive OSCTAP block with 25 ml volume on each side (5 ml normal saline plus 20 ml of 0.25 % bupivacaine) Receives: Drug: Bupivacaine plus normal saline |
| Group B | Active comparator | 24 patients will receive OSCTAP block with 25 ml volume on each side (5 ml normal saline containing 500 mg MgSO4 plus 20 ml of 0.25% bupivacaine) Receives: Drug: Bupivacaine plus normal saline containing MgSO4 |
| Group C | Active comparator | 24 patients will receive OSCTAP block with 25 ml volume on each side (5 ml normal saline containing 250 mg MgSO4 plus 20 ml of 0.25% bupivacain) Receives: Drug: Bupivacaine plus normal saline containing MgSO4 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of adding different doses of MgSO4 to bupivacaine via OSCTAB block on postoperative pain according to (NRS) for 24 hours in patients scheduled for LC.
NRS Score: used to assess pain intensity . It is one of the most commonly used pain scales in medicine. The NRS consists of a numeric version of the visual analog scale. It is a horizontal line with an eleven point numeric range. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible . This scale can be administered verbally. Rescue analgesia will be nalbuphine 0.1 mg/kg IV when the NRS ≥ 4.
Measured: 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 posted28 Nov 2023
- Study start1 Jan 2024 (estimated)
- Primary completion20 Jan 2025 (estimated)
- Study completion20 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Postoperative Pain ManagementStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Yamany Mohamed Kamel, Assiut University
- Investigators
- Fatma Askar, Study chair, Professor of Anesthesia and Intensive Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148168
- Sponsor's protocol ID
- Post operative pain
- Status last verified
- Nov 2023
- First submitted
- 27 Oct 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Grape S, Kirkham KR, Akiki L, Albrecht E. Transversus abdominis plane block versus local anesthetic wound infiltration for optimal analgesia after laparoscopic cholecystectomy: A systematic review and meta-analysis with trial sequential analysis. J Clin Anesth. 2021 Dec;75:110450. doi: 10.1016/j.jclinane.2021.110450. Epub 2021 Jul 6.
PubMed 34243030Altiparmak B, Korkmaz Toker M, Uysal AI, Kuscu Y, Gumus Demirbilek S. Ultrasound-guided erector spinae plane block versus oblique subcostal transversus abdominis plane block for postoperative analgesia of adult patients undergoing laparoscopic cholecystectomy: Randomized, controlled trial. J Clin Anesth. 2019 Nov;57:31-36. doi: 10.1016/j.jclinane.2019.03.012. Epub 2019 Mar 6.
PubMed 30851501
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Different Doses of Magnesium Sulphate in Oblique Subcostal TAP Block for Laparoscopic Cholecystectomy: a Randomized Double-blind Controlled Study
- ClinicalTrials.gov ID
- NCT06148168
- Acronym / sponsor ID
- Post operative pain
- Conditions
- Postoperative Pain Management
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 20 Jan 2025 (estimated)
- Study completion
- 20 Feb 2025 (estimated)
- First posted
- 28 Nov 2023 (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 aim of this study is to evaluate the effect of adding different doses of MgSO4 to bupivacaine via OSCTAB block on postoperative pain control for 24 hours in patients scheduled for LC.
Detailed description
Laparoscopic cholecystectomy (LC) is a gold standard for management of gallbladder stones. Early and easily recovery, less operative morbidities, less postoperative pain, improved cosmetics, less hospitalization days and decreased cost are the superiorities of laparoscopic cholecystectomies over open surgical procedures.
Postoperative pain is the major obstacle for early postoperative ambulation and prolongs the hospital stay. Moreover, it has been hypothesized that intense acute pain after LC may predict development of chronic pain (e.g., post laparoscopic cholecystectomy syndrome). So, aggressive perioperative pain prevention is mandatory.
This pain is routinely managed using opiates, which has several side effects. Transversus abdominis plane (TAP) block is a regional anesthetic technique that has gradually become an alternative for postoperative pain control during laparoscopic abdominal surgeries. It involves the infusion of local anesthetic into the fascial plane of the abdominal wall. Oblique subcostal transversus abdominis plane (OSCTAP) block is an US-guided regional anesthesia technique that anesthetizes the nerves of the lower and upper anterior abdominal wall, specifically from T6 to L1.
Rafi et al and McDonnell et al were the first to describe (OSCTAP) block. They described an anatomical landmark technique and provided evidence of blockade to the mid/lower thoracic and upper lumbar spinal nerves as they travelled in the fascial plane between the transversus abdominis (TA) and internal oblique (IO) muscles.
Evidence supporting the presence of (NMDA) receptors in skin and muscles have led to the use of (MgSO4) which is NMDA antagonist via different routes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Bupivacaine plus normal saline24 patients will receive OSCTAP block with 25 ml volume on each side (5 ml normal saline plus 20 ml of 0.25 % bupivacaine) |
| Group B | Active comparator | Drug: Bupivacaine plus normal saline containing MgSO424 patients will receive OSCTAP block with 25 ml volume on each side (5 ml normal saline containing 500 mg MgSO4 plus 20 ml of 0.25% bupivacaine) |
| Group C | Active comparator | Drug: Bupivacaine plus normal saline containing MgSO424 patients will receive OSCTAP block with 25 ml volume on each side (5 ml normal saline containing 250 mg MgSO4 plus 20 ml of 0.25% bupivacain) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • Patients programmed for elective LC.
Key exclusion criteria (8 listed)
- • Patient refusal.
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 plus normal salineUnlike specific peripheral nerve blocks, TAP block is a non-dermatomal "field block". Even with the same US-guided technique, the extent of spread of local anesthetics can be variable due to individual anatomical variations (18). In order to perform the blocks, abdominal skin will be prepared and covered with sterile drapes. The needle can be introduced by multiple punctures along the oblique subcostal line from the xiphoid process towards the anterior part of the iliac crest .Thus, LA will be injected in the TAP along this line provides both upper and lower abdominal wall analgesia. The OSCTAP block more consistently covers L1 dermatome. After negative aspiration, a test injection with 1 ml of 0.9% normal saline will be performed to confirm the needle location. If the intended sensation will not decreased in surgical dermatomes after 30 min, the patient will be regarded to have a failed block and will be excluded from the study. | Drug | Group A |
| Bupivacaine plus normal saline containing MgSO4Bupivacaine plus normal saline containing MgSO4 | Drug | Group B, Group C |
Primary outcome
The effect of adding different doses of MgSO4 to bupivacaine via OSCTAB block on postoperative pain according to (NRS) for 24 hours in patients scheduled for LC.
Time frame: 24 hours postoperatively
NRS Score: used to assess pain intensity . It is one of the most commonly used pain scales in medicine. The NRS consists of a numeric version of the visual analog scale. It is a horizontal line with an eleven point numeric range. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible . This scale can be administered verbally. Rescue analgesia will be nalbuphine 0.1 mg/kg IV when the NRS ≥ 4.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Background: PubMed 34243030Grape S, Kirkham KR, Akiki L, Albrecht E. Transversus abdominis plane block versus local anesthetic wound infiltration for optimal analgesia after laparoscopic cholecystectomy: A systematic review and meta-analysis with trial sequential analysis. J Clin Anesth. 2021 Dec;75:110450. doi: 10.1016/j.jclinane.2021.110450. Epub 2021 Jul 6.
- Background: PubMed 30851501Altiparmak B, Korkmaz Toker M, Uysal AI, Kuscu Y, Gumus Demirbilek S. Ultrasound-guided erector spinae plane block versus oblique subcostal transversus abdominis plane block for postoperative analgesia of adult patients undergoing laparoscopic cholecystectomy: Randomized, controlled trial. J Clin Anesth. 2019 Nov;57:31-36. doi: 10.1016/j.jclinane.2019.03.012. Epub 2019 Mar 6.
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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.
Fatma Askar study chair
Professor of Anesthesia and Intensive Care
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bupivacaine plus normal saline and Bupivacaine plus normal saline containing MgSO4 in people with Postoperative Pain Management, run by Assiut 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 4 inclusion and 8 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 28 Nov 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Mahmoud Yamany (01229038037, m_yamany2016@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of adding different doses of MgSO4 to bupivacaine via OSCTAB block on postoperative pain according to (NRS) for 24 hours in patients scheduled for LC. (time frame: 24 hours postoperatively). 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 NCT06148168, which also lists 2 linked publications.
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 28 Nov 2023.