Upper Abdominal Cancer SurgeryPhase 4NCT06677827
Effect of Adding Magnesium Sulphate as Adjuvant to Bupivacaine in Ultrasound Guided External Oblique Intercostal Plane Block in Upper Abdominal Cancer Surgery.to Assess the Total Postoperative Opioid Consumption in the First 24 h and Evaluate Post Operative VAS Score
A Phase 4 study testing Bupivacaine and Magnesium Sulfate and Bupivacaine 0.125% in people with Upper Abdominal Cancer Surgery, run by Assiut University.
Trial summary
double blind randomized controlled trial will be conducted on upper abdominal cancer surgery cases to study the effect of Adding Magnesium Sulphate as Adjuvant to Bupivacaine in Ultrasound Guided External Oblique Intercostal Plane Block in Upper Abdominal Cancer Surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Abdominal Cancer Surgery
- What is being tested?
- Bupivacaine and Magnesium Sulfate and Bupivacaine 0.125%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Jan 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a. Age >18 years old b. Both sex c. Patients who were in risk-scoring groups I-III of the American Society of Anesthesiologists (ASA)
Who cannot join
- c. Patients' refusal, d. History of allergy to any of the study medications e. Any contraindications to regional anesthesia. f. Patients with anatomical abnormalities. g. Patients have hemodynamic instability. h. Patients with local infection, and suspected intra-abdominal sepsis.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Adding Magnesium Sulphate as Adjuvant to Bupivacaine in Ultrasound Guided External Oblique Intercostal Plane Block in Upper Abdominal Cancer Surgery
double blind randomized controlled trial will be conducted on upper abdominal cancer surgery cases to study the effect of Adding Magnesium Sulphate as Adjuvant to Bupivacaine in Ultrasound Guided External Oblique Intercostal Plane Block in Upper Abdominal Cancer Surgery
Read the detailed description
Despite advances in the field of medical and radiation oncology, surgical resection is a crucial intervention and remains the mainstay of gold standard treatment. Upper abdominal incisions such as the oblique subcostal laparotomy are a cause of severe pain and can lead to significant respiratory impairment . Numerous studies have demonstrated that when enhanced recovery procedures (ERPs) are used, hospital length of stay, time to return to normal function, postoperative ileus duration, thromboembolic complications, morbidity, and all of these factors are all reduced. Traditionally, epidural analgesia has been the cornerstone of pain control in such surgeries. However, it has limitations, including potential complications and contraindications in certain patients.
The innervation of the upper abdominal wall originates from the T6th and T10th intercostal nerves and requires effective blocking of these nerves to achieve analgesic and anesthetic efficacy. For upper abdominal surgeries, the ideal regional anesthesia technique should target both the anterior and lateral cutaneous branches of the intercostal nerves from T6 to T10. Hesham Elsharkawy et al demonstrated the potential mechanism of the external oblique intercostal fascial plane block (EOIB) in a cadaver study in which both lateral and anterior branches of the intercostal nerves T7-T10 were stained. Patients to whom this block was applied exhibited consistent dermatomal sensory blockade between T6-T10 in the anterior axillary line and T6-T9 in the midline. It has been shown that this block can be used in the clinical setting for upper abdominal wall analgesia. The external oblique intercostal (EOI) block has shown promising results in covering the anterior and lateral upper abdominal wall. It's simple, effective, and convenient block, particularly in the context of morbid obesity.
The external oblique intercostal block offers effective pain relief for the upper abdomen without the systemic effects of sympathetic blockade and without impairing motor or bladder function. It ensure optimal pain management, promote early postoperative mobilization, and support functional recovery.
Magnesium is a calcium blocker and an NMDA receptor antagonist. Research has demonstrated that magnesium sulfate [MgSO4] has an analgesic effect by blocking N-methyl-D-aspartate [NMDA] receptors and associated calcium channels, thereby preventing central sensitization that arises due to peripheral nociceptive stimulation. Magnesium may influence the central nervous system's (CNS) ability to transmit nociceptive signals and pain sensation in the central nervous system (CNS) by inhibiting N-methyl-D-aspartate (NMDA) receptor and calcium channels. It was used recently as a powerful analgesic adjuvant resulting in reduced postoperative opioid consumption.
- Conditions
- Upper Abdominal Cancer Surgery
- Being tested
- Bupivacaine, Magnesium Sulfate and Bupivacaine 0.125%
- Keywords
- External Oblique Intercostal Plane Block, Magnesium Sulphate, Bupivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
External Oblique Intercostal plane block technique with 20 ml bupivacaine 0.25% only bilateral
Magnesium Sulfate and Bupivacaine 0.125%Drug
External Oblique Intercostal plane block technique with 20 ml bupivacaine 0.25%+200 mg magnesium sulphate bilateral
| Study group | Role | What they receive |
|---|---|---|
| group bupivacaine | Experimental | Not described Receives: Drug: Bupivacaine |
| group magnesium sulphate &bupivacaine | Experimental | Not described Receives: Drug: Magnesium Sulfate and Bupivacaine 0.125% |
What is being measured
The primary outcome is the main question the study is designed to answer.
dose postoperative opioid consumption
the total dose postoperative opioid consumption in the first 24 h.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Upper Abdominal Cancer SurgeryStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be divided into two groups Group 1: 20 ml bupivacaine 0.25%+200 mg magnesium sulphate Ultrasound guided external oblique intercostal plane block bilateral Group 2: 20 ml bupivacaine 0.25% only Ultrasound guided external oblique intercostal plane block bilateral
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raghda Ramadan Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677827
- Sponsor's protocol ID
- MgSO4 EOIB Abd Cancer Surgery
- Status last verified
- Nov 2024
- First submitted
- 5 Nov 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
El Sherif F, Gomaa Sayed D, Fares KM, Mohamed SA, Osman AM, Kamal Sayed A, Mamdouh Kamal S. Magnesium Sulfate in Pediatric Abdominal Cancer Surgery: Safety and Efficacy in Ultrasound-Guided Transversus Abdominis Plane (US-TAP) Block in Conjugation with Levobupivacaine. Local Reg Anesth. 2023 Sep 12;16:133-141. doi: 10.2147/LRA.S425649. eCollection 2023.
PubMed 37719936Cosarcan SK, Ercelen O. The analgesic contribution of external oblique intercostal block: Case reports of 3 different surgeries and 3 spectacular effects. Medicine (Baltimore). 2022 Sep 9;101(36):e30435. doi: 10.1097/MD.0000000000030435.
PubMed 36086688Mehmet Selim C, Halide S, Erkan Cem C, Onur K, Sedat H, Senem U. Efficacy of Unilateral External Oblique Intercostal Fascial Plane Block Versus Subcostal TAP Block in Laparoscopic Cholecystectomy: Randomized, Prospective Study. Surg Innov. 2024 Aug;31(4):381-388. doi: 10.1177/15533506241256529. Epub 2024 May 23.
PubMed 38780355Elsharkawy H, Kolli S, Soliman LM, Seif J, Drake RL, Mariano ER, El-Boghdadly K. The External Oblique Intercostal Block: Anatomic Evaluation and Case Series. Pain Med. 2021 Nov 26;22(11):2436-2442. doi: 10.1093/pm/pnab296.
PubMed 34626112Korkusuz M, Basaran B, Et T, Bilge A, Yarimoglu R, Yildirim H. Bilateral external oblique intercostal plane block (EOIPB) in patients undergoing laparoscopic cholecystectomy: A randomized controlled trial. Saudi Med J. 2023 Oct;44(10):1037-1046. doi: 10.15537/smj.2023.44.10.20230350.
PubMed 37777270Lin T, Yu J, Hu Y, Liu H, Lu Y, Zhao M, Chen H, Chen X, Li G. [Preliminary experience of dual-port laparoscopic distal gastrectomy for gastric cancer]. Zhonghua Wei Chang Wai Ke Za Zhi. 2019 Jan 25;22(1):35-42. Chinese.
PubMed 30703792
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Magnesium Sulphate as Adjuvant to Bupivacaine in Ultrasound Guided External Oblique Intercostal Plane Block in Upper Abdominal Cancer Surgery
- ClinicalTrials.gov ID
- NCT06677827
- Acronym / sponsor ID
- MgSO4 EOIB Abd Cancer Surgery
- Conditions
- Upper Abdominal Cancer Surgery
- Keywords
- External Oblique Intercostal Plane Block, Magnesium Sulphate, Bupivacaine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 7 Nov 2024 (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.
double blind randomized controlled trial will be conducted on upper abdominal cancer surgery cases to study the effect of Adding Magnesium Sulphate as Adjuvant to Bupivacaine in Ultrasound Guided External Oblique Intercostal Plane Block in Upper Abdominal Cancer Surgery
Detailed description
Despite advances in the field of medical and radiation oncology, surgical resection is a crucial intervention and remains the mainstay of gold standard treatment. Upper abdominal incisions such as the oblique subcostal laparotomy are a cause of severe pain and can lead to significant respiratory impairment . Numerous studies have demonstrated that when enhanced recovery procedures (ERPs) are used, hospital length of stay, time to return to normal function, postoperative ileus duration, thromboembolic complications, morbidity, and all of these factors are all reduced. Traditionally, epidural analgesia has been the cornerstone of pain control in such surgeries. However, it has limitations, including potential complications and contraindications in certain patients.
The innervation of the upper abdominal wall originates from the T6th and T10th intercostal nerves and requires effective blocking of these nerves to achieve analgesic and anesthetic efficacy. For upper abdominal surgeries, the ideal regional anesthesia technique should target both the anterior and lateral cutaneous branches of the intercostal nerves from T6 to T10. Hesham Elsharkawy et al demonstrated the potential mechanism of the external oblique intercostal fascial plane block (EOIB) in a cadaver study in which both lateral and anterior branches of the intercostal nerves T7-T10 were stained. Patients to whom this block was applied exhibited consistent dermatomal sensory blockade between T6-T10 in the anterior axillary line and T6-T9 in the midline. It has been shown that this block can be used in the clinical setting for upper abdominal wall analgesia. The external oblique intercostal (EOI) block has shown promising results in covering the anterior and lateral upper abdominal wall. It's simple, effective, and convenient block, particularly in the context of morbid obesity.
The external oblique intercostal block offers effective pain relief for the upper abdomen without the systemic effects of sympathetic blockade and without impairing motor or bladder function. It ensure optimal pain management, promote early postoperative mobilization, and support functional recovery.
Magnesium is a calcium blocker and an NMDA receptor antagonist. Research has demonstrated that magnesium sulfate [MgSO4] has an analgesic effect by blocking N-methyl-D-aspartate [NMDA] receptors and associated calcium channels, thereby preventing central sensitization that arises due to peripheral nociceptive stimulation. Magnesium may influence the central nervous system's (CNS) ability to transmit nociceptive signals and pain sensation in the central nervous system (CNS) by inhibiting N-methyl-D-aspartate (NMDA) receptor and calcium channels. It was used recently as a powerful analgesic adjuvant resulting in reduced postoperative opioid consumption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be divided into two groups Group 1: 20 ml bupivacaine 0.25%+200 mg magnesium sulphate Ultrasound guided external oblique intercostal plane block bilateral Group 2: 20 ml bupivacaine 0.25% only Ultrasound guided external oblique intercostal plane block bilateral
| Arm | Type | Receives |
|---|---|---|
| group bupivacaine | Experimental | Drug: Bupivacaine |
| group magnesium sulphate &bupivacaine | Experimental | Drug: Magnesium Sulfate and Bupivacaine 0.125% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- a. Age >18 years old b. Both sex c. Patients who were in risk-scoring groups I-III of the American Society of Anesthesiologists (ASA)
Key exclusion criteria (1 listed)
- c. Patients' refusal, d. History of allergy to any of the study medications e. Any contraindications to regional anesthesia. f. Patients with anatomical abnormalities. g. Patients have hemodynamic instability. h. Patients with local infection, and suspected intra-abdominal sepsis.
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 |
|---|---|---|
| BupivacaineExternal Oblique Intercostal plane block technique with 20 ml bupivacaine 0.25% only bilateral | Drug | group bupivacaine |
| Magnesium Sulfate and Bupivacaine 0.125%External Oblique Intercostal plane block technique with 20 ml bupivacaine 0.25%+200 mg magnesium sulphate bilateral | Drug | group magnesium sulphate &bupivacaine |
Primary outcome
dose postoperative opioid consumption
Time frame: baseline
the total dose postoperative opioid consumption in the first 24 h.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2024.
- Results publication: PubMed 37719936El Sherif F, Gomaa Sayed D, Fares KM, Mohamed SA, Osman AM, Kamal Sayed A, Mamdouh Kamal S. Magnesium Sulfate in Pediatric Abdominal Cancer Surgery: Safety and Efficacy in Ultrasound-Guided Transversus Abdominis Plane (US-TAP) Block in Conjugation with Levobupivacaine. Local Reg Anesth. 2023 Sep 12;16:133-141. doi: 10.2147/LRA.S425649. eCollection 2023.
- Results publication: PubMed 36086688Cosarcan SK, Ercelen O. The analgesic contribution of external oblique intercostal block: Case reports of 3 different surgeries and 3 spectacular effects. Medicine (Baltimore). 2022 Sep 9;101(36):e30435. doi: 10.1097/MD.0000000000030435.
- Results publication: PubMed 38780355Mehmet Selim C, Halide S, Erkan Cem C, Onur K, Sedat H, Senem U. Efficacy of Unilateral External Oblique Intercostal Fascial Plane Block Versus Subcostal TAP Block in Laparoscopic Cholecystectomy: Randomized, Prospective Study. Surg Innov. 2024 Aug;31(4):381-388. doi: 10.1177/15533506241256529. Epub 2024 May 23.
- Results publication: PubMed 34626112Elsharkawy H, Kolli S, Soliman LM, Seif J, Drake RL, Mariano ER, El-Boghdadly K. The External Oblique Intercostal Block: Anatomic Evaluation and Case Series. Pain Med. 2021 Nov 26;22(11):2436-2442. doi: 10.1093/pm/pnab296.
- Results publication: PubMed 37777270Korkusuz M, Basaran B, Et T, Bilge A, Yarimoglu R, Yildirim H. Bilateral external oblique intercostal plane block (EOIPB) in patients undergoing laparoscopic cholecystectomy: A randomized controlled trial. Saudi Med J. 2023 Oct;44(10):1037-1046. doi: 10.15537/smj.2023.44.10.20230350.
- Results publication: PubMed 30703792Lin T, Yu J, Hu Y, Liu H, Lu Y, Zhao M, Chen H, Chen X, Li G. [Preliminary experience of dual-port laparoscopic distal gastrectomy for gastric cancer]. Zhonghua Wei Chang Wai Ke Za Zhi. 2019 Jan 25;22(1):35-42. Chinese.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine and Magnesium Sulfate and Bupivacaine 0.125% in people with Upper Abdominal Cancer Surgery, 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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 7 Nov 2024. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raghda Radman Ahmed Mohamed, resident doctors (+201005653009, Raghda.16266161@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
dose postoperative opioid consumption (time frame: baseline). 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 NCT06677827, which also lists 6 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 7 Nov 2024.