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AzTrials

Laparoscopic CholecystectomyPhase 4NCT06743919

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

A Phase 4 study testing Magnesium sulfate 50% - 1g/h, dexmedetomidine 0.5 µg/kg IV and Bupivacaine in people with Laparoscopic Cholecystectomy, run by Assiut University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Laparoscopic Cholecystectomy
What is being tested?
Magnesium sulfate 50% - 1g/h, dexmedetomidine 0.5 µg/kg IV and Bupivacaine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
1 siteEgypt
Study dates
1 Jan 2025to 1 Mar 2026
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • • 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.

Who cannot join

  • •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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Assiut university hospitals

    Asyut, Asyut Governorate, 2067011

Other trials in Egypt

About this study

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.

Read the detailed description

Transversus abdominis plane (TAP) block is a recent analgesic technique with efficacy in perioperative pain therapy for LC. 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. There weren't enough studies in the literature evaluating the OSCTAP block for pain management after LC.

Rafi et al and McDonnell et al were first to describe this novel abdominal field 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.

The OSCTAB block provides more effective analgesia than other TAP blocks. Numerous regional anesthetic adjuvants.

such as dexmedetomidine, clonidine, epinephrine, dexamethasone, and magnesium sulphate (MgSO4) are usually combined with enhancement of analgesic efficacy.

Recently, these adjuvants added to LA solution for prolonging the effect of TAP block with promising results.

Being tested
Magnesium sulfate 50% - 1g/h, dexmedetomidine 0.5 µg/kg IV, Bupivacaine
Keywords
Oblique Subcostal Tap Block

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnesium sulfate 50% - 1g/hDrug

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

  • dexmedetomidine 0.5 µg/kg IVDrug

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

  • BupivacaineDrug

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

Study groups in NCT06743919
Study groupRoleWhat they receive
group 1Experimentalpatient will receive 20 ml bupivacaine 0.25% plus 500 mg magnesium sulfate in 5ml normal saline on both sides.
Receives: Drug: Magnesium sulfate 50% - 1g/h; Drug: Bupivacaine
group 2Experimentalpatients will receive 20 ml bupivacaine 0.25% plus o .5 microg per kg dexmedetomidine in 5 ml normal saline on both sides.
Receives: Drug: dexmedetomidine 0.5 µg/kg IV; Drug: Bupivacaine
group 3Placebo comparatorpatients will receive 20 ml bupivacaine 0.25% plus 5 ml normal saline on both sides.
Receives: Drug: Bupivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. total postoperative analgesic consumption

    total postoperative analgesic consumption during the first 24 hours

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Dec 2024
  2. Study start1 Jan 2025
  3. Primary completion1 Jan 2026
  4. Study completion1 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06743919
Sponsor's protocol ID
OSCTAP Cholecystectomy
Status last verified
Oct 2026
First submitted
17 Dec 2024
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 38359350

  • 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.

    PubMed 20514952

  • 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.

    PubMed 16418039

  • 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.

    PubMed 20830871

  • 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.

    PubMed 26056753

  • 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.

    PubMed 18428988

  • 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.

    PubMed 16334446

  • 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.

    PubMed 22763903

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Magnesium sulfate 50% - 1g/h, dexmedetomidine 0.5 µg/kg IV and Bupivacaine in people with Laparoscopic Cholecystectomy, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

total postoperative analgesic consumption (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06743919, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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