Clinical trial NCT06148168: Magnesium Sulphate in Oblique Subcostal TAP Block
Official title: Comparative Evaluation of Different Doses of Magnesium Sulphate in Oblique Subcostal TAP Block for Laparoscopic Cholecystectomy: a Randomized Double-blind Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Postoperative Pain Management
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

* • 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.

Exclusion Criteria:

* • 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.

Primary outcomes:
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.
timeFrame: 24 hours postoperatively
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Professor of Anesthesia and Intensive Care
name: Fatma Askar
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.