Magnesium Sulphate in Oblique Subcostal TAP Block

NCT06148168 | Unknown Phase 2

• 1 other identifier: Post operative pain
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Postoperative Pain Management

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hours postoperatively

Study Arms (3)

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)

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)

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)

Drug: Bupivacaine plus normal saline containing MgSO4

Interventions

Bupivacaine plus normal saline DRUG

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.

Group A

Bupivacaine plus normal saline containing MgSO4 DRUG

Bupivacaine plus normal saline containing MgSO4

Group B; Group C

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• 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.

  PMID: 34243030 BACKGROUND

• Altiparmak 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.

  PMID: 30851501 BACKGROUND

MeSH Terms

Interventions

Bupivacaine; Saline Solution

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Fatma Askar

  Professor of Anesthesia and Intensive Care

  STUDY CHAIR

Central Study Contacts

Mahmoud Yamany

CONTACT

01229038037; m_yamany2016@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: October 27, 2023
• First Posted: November 28, 2023
• Study Start: January 1, 2024
• Primary Completion: January 20, 2025
• Study Completion: February 20, 2025
• Last Updated: November 28, 2023

Record last verified: 2023-11