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

November 5, 2024 updated by: Raghda Ramadan Ahmed, Assiut University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

68

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group bupivacaine
Drug: Bupivacaine
External Oblique Intercostal plane block technique with 20 ml bupivacaine 0.25% only bilateral
Experimental: group magnesium sulphate &bupivacaine
Drug: Magnesium Sulfate and Bupivacaine 0.125%
External Oblique Intercostal plane block technique with 20 ml bupivacaine 0.25%+200 mg magnesium sulphate bilateral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
dose postoperative opioid consumption
Time Frame: baseline
the total dose postoperative opioid consumption in the first 24 h.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

November 5, 2024

First Submitted That Met QC Criteria

November 5, 2024

First Posted (Estimated)

November 7, 2024

Study Record Updates

Last Update Posted (Estimated)

November 7, 2024

Last Update Submitted That Met QC Criteria

November 5, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MgSO4 EOIB Abd Cancer Surgery

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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