Adding Magnesium Sulfate or Dexmedetomidine to Bupivacaine in Oblique Subcostal Tap Block for Laparoscopic Cholecystectomy: a Randomized Double -Blind Controlled Study

NCT06743919 | Not Yet Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: OSCTAP Cholecystectomy
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

Brief Summary

Laparoscopic cholecystectomy (LC) is one of the commonly performed surgical procedures associated with a moderate degree of postoperative pain especially on the 1st postoperative day. Adequate postoperative analgesia allows early patient ambulation, decreases analgesic requirements, and 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 analgesia is needed. the aim of the study is To compare the analgesic effect of magnesium sulfate combined with bupivacaine versus bupivacaine combined dexmedetomidine via OSCTAB block on postoperative pain control for 24 hours in patients scheduled for LC.

Conditions

Laparoscopic Cholecystectomy

Keywords

Oblique Subcostal Tap Block

Outcome Measures

Primary Outcomes (1)

• post operative ( NRS score

  analgesic effect of OSCTAB block on postoperative pain control according to (NRS) for 24 hours in patients scheduled for LC.

  24 hours

Study Arms (3)

group 1

EXPERIMENTAL

patient will receive 20 ml bupivacaine 0.25% plus 500 mg magnesium sulfate in 5ml normal saline on both sides.

Drug: Magnesium sulfate 50% - 1g/h; Drug: Bupivacaine

group 2

EXPERIMENTAL

patients will receive 20 ml bupivacaine 0.25% plus o .5 microg per kg dexmedetomidine in 5 ml normal saline on both sides.

Drug: dexmedetomidine 0.5 µg/kg IV; Drug: Bupivacaine

group 3

PLACEBO COMPARATOR

patients will receive 20 ml bupivacaine 0.25% plus 5 ml normal saline on both sides.

Drug: Bupivacaine

Interventions

Magnesium sulfate 50% - 1g/h DRUG

magnesium sulfate group 20 ml bupivacaine 0.25% plus 500 mg magnesium sulfate in 5ml normal saline on both sides.

group 1

dexmedetomidine 0.5 µg/kg IV DRUG

dexmedetomidine group 20 ml bupivacaine 0.25% plus o .5 microg per kg dexmedetomidine in 5 ml normal saline on both sides.

group 2

Bupivacaine DRUG

20 ml bupivacaine 0.25% plus 5 ml normal saline on both sides.

group 1; group 2; group 3

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 (8)

• Sun C, He Z, Feng B, Huang Y, Liu D, Sun Z. Effect of Intraperitoneal Instillation of Dexmedetomidine With Local Anesthetics in Laparoscopic Cholecystectomy: A Systematic Review and Meta-analysis of Randomized Trials. Surg Laparosc Endosc Percutan Tech. 2024 Apr 1;34(2):222-232. doi: 10.1097/SLE.0000000000001262.

  PMID: 38359350 BACKGROUND

• Lee TH, Barrington MJ, Tran TM, Wong D, Hebbard PD. Comparison of extent of sensory block following posterior and subcostal approaches to ultrasound-guided transversus abdominis plane block. Anaesth Intensive Care. 2010 May;38(3):452-60. doi: 10.1177/0310057X1003800307.

  PMID: 20514952 BACKGROUND

• O'Donnell BD, McDonnell JG, McShane AJ. The transversus abdominis plane (TAP) block in open retropubic prostatectomy. Reg Anesth Pain Med. 2006 Jan-Feb;31(1):91. doi: 10.1016/j.rapm.2005.10.006. No abstract available.

  PMID: 16418039 BACKGROUND

• Hebbard PD, Barrington MJ, Vasey C. Ultrasound-guided continuous oblique subcostal transversus abdominis plane blockade: description of anatomy and clinical technique. Reg Anesth Pain Med. 2010 Sep-Oct;35(5):436-41. doi: 10.1097/aap.0b013e3181e66702.

  PMID: 20830871 BACKGROUND

• Hutchins J, Delaney D, Vogel RI, Ghebre RG, Downs LS Jr, Carson L, Mullany S, Teoh D, Geller MA. Ultrasound guided subcostal transversus abdominis plane (TAP) infiltration with liposomal bupivacaine for patients undergoing robotic assisted hysterectomy: A prospective randomized controlled study. Gynecol Oncol. 2015 Sep;138(3):609-13. doi: 10.1016/j.ygyno.2015.06.008. Epub 2015 Jun 6.

  PMID: 26056753 BACKGROUND

• Rozen WM, Tran TM, Ashton MW, Barrington MJ, Ivanusic JJ, Taylor GI. Refining the course of the thoracolumbar nerves: a new understanding of the innervation of the anterior abdominal wall. Clin Anat. 2008 May;21(4):325-33. doi: 10.1002/ca.20621.

  PMID: 18428988 BACKGROUND

• Bisgaard T, Rosenberg J, Kehlet H. From acute to chronic pain after laparoscopic cholecystectomy: a prospective follow-up analysis. Scand J Gastroenterol. 2005 Nov;40(11):1358-64. doi: 10.1080/00365520510023675.

  PMID: 16334446 BACKGROUND

• Petersen PL, Stjernholm P, Kristiansen VB, Torup H, Hansen EG, Mitchell AU, Moeller A, Rosenberg J, Dahl JB, Mathiesen O. The beneficial effect of transversus abdominis plane block after laparoscopic cholecystectomy in day-case surgery: a randomized clinical trial. Anesth Analg. 2012 Sep;115(3):527-33. doi: 10.1213/ANE.0b013e318261f16e. Epub 2012 Jul 4.

  PMID: 22763903 BACKGROUND

MeSH Terms

Interventions

Magnesium Sulfate; Dexmedetomidine; Bupivacaine

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Khaled Zaki Mousa Sayed Mansour, resident doctor

CONTACT

+2 01032468020; khaled.15259233@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at Assiut University hospital

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 20, 2024
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 20, 2024

Record last verified: 2024-12