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

NCT06677827 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: MgSO4 EOIB Abd Cancer Surgery
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Upper Abdominal Cancer Surgery

Keywords

External Oblique Intercostal Plane Block; Magnesium Sulphate; Bupivacaine

Outcome Measures

Primary Outcomes (1)

• dose postoperative opioid consumption

  the total dose postoperative opioid consumption in the first 24 h.

  baseline

Study Arms (2)

group bupivacaine

EXPERIMENTAL

Drug: Bupivacaine

group magnesium sulphate &bupivacaine

EXPERIMENTAL

Drug: Magnesium Sulfate and Bupivacaine 0.125%

Interventions

Bupivacaine DRUG

External Oblique Intercostal plane block technique with 20 ml bupivacaine 0.25% only bilateral

group bupivacaine

Magnesium Sulfate and Bupivacaine 0.125% DRUG

External Oblique Intercostal plane block technique with 20 ml bupivacaine 0.25%+200 mg magnesium sulphate bilateral

group magnesium sulphate &bupivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (6)

• 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.

  PMID: 37719936 BACKGROUND

• Cosarcan 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.

  PMID: 36086688 BACKGROUND

• Mehmet 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.

  PMID: 38780355 BACKGROUND

• Elsharkawy 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.

  PMID: 34626112 BACKGROUND

• Korkusuz 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.

  PMID: 37777270 BACKGROUND

• Lin 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.

  PMID: 30703792 BACKGROUND

MeSH Terms

Interventions

Bupivacaine; Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Central Study Contacts

Raghda Radman Ahmed Mohamed, resident doctors

CONTACT

+201005653009; Raghda.16266161@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: An independent anesthesiologist randomly using computer-generated random numbers divided the patients into 2 groups :(Group 1 and Group 2). Each group will include 34 patients. We discreetly placed the randomization results in envelopes until the end of the study. The researchers who were responsible for postoperative follow-up and data processing were blinded to the group allocation during the whole study period. All patients were also blinded to the group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at Anesthesia, Intensive Care and Pain Management

Model Details: 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

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 7, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: November 7, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL