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Regional AnesthesiaNCT06120088

U.S. Guided Erector Spinae Block for Postoperative Pain Management in Paraumbilical Hernia Repair Patients

An observational study of Regional Anesthesia, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Abdominal surgery is one of the most definitive and mainstay treatment options for abdominal pathologies in clinical practice. Acute postoperative pain is a major challenge in the postoperative period. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Regional Anesthesia
What is being tested?
Bubpivacaine, dexamethasone and fentanyl
How many people
300 participants
Where
No sites listed yet
Study dates
1 Dec 2023to 1 Jan 2025
Phase
Observational
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
  • Adult

Study population: Sample size was calculated using G power 3.1.9.2. To be able to calculate the difference in first analgesic request between the three studied groups with α error of 0.05, power of study of 0.9, equal group assignment and 0.4 effect size and using ANOVA test for comparison we need to include 27 patients in each group, another 3 patients will be added to each group to compensate for violation at the study protocol.

Who may be able to join

  • Age group : 18-60 years old
  • Both genders
  • Patient scheduled for paraumbilical hernia surgeries

Who cannot join

  • Allergy to medications used in this study
  • Patient's refusal to participate in this study
  • Recurrent cases
  • Any complications to local blocks
  • Emergency surgical procedures

Trial locations and contacts

No sites are listed yet.

Rehab Ahmed, master contact

01094878158 ext. +20

Rehabahmed5656@yahoo.com

Mahmoud Mohammed, prof contact

01006464560 ext. +20

Mahmoudkamel88.mk@gmail.com

About this study

Official title: U.S Guided Erector Spinae Block for Postoperative Pain Control in Patients Undergoing Para Umblical Hernial Repair. (Comparative Study ).

Abdominal surgery is one of the most definitive and mainstay treatment options for abdominal pathologies in clinical practice. Acute postoperative pain is a major challenge in the postoperative period. Although opioids are commonly used for analgesia after paraumbilical hernia, they can lead to side effects, such as nausea and vomiting, constipation, pruritus, and life-threatening respiratory depression. Regional anesthetic techniques are commonly used to prevent or minimize these side effects. The objective of this study is to assess the effectiveness of erector spinae plane block (ESPB) and standard medical (no block) pain management after paraumbilical hernia.

Being tested
Bubpivacaine, dexamethasone, fentanyl

What participants receive

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

  • BubpivacaineDrug

    Bupivacaine is a long-acting local anesthetic commonly used to provide pain relief by blocking nerve signals in a specific area. It's often utilized for various medical procedures and surgeries, offering prolonged numbing effects.

  • dexamethasoneDrug

    Dexamethasone is a potent corticosteroid with anti-inflammatory properties. It's frequently employed as an adjunct in medical treatments to reduce inflammation and swelling, and in some cases, to prevent nausea and vomiting associated with certain medications or procedures.

  • fentanylDrug

    Fentanyl is a powerful synthetic opioid pain reliever. It acts on the central nervous system to alleviate severe pain. Fentanyl is significantly potent and is used in medical settings for acute pain management, such as during surgeries or for chronic pain in cases where other opioids may not be as effective.

Study groups in NCT06120088
Study groupRoleWhat they receive
The BupivacainePatients in this group received bilateral ultrasound-guided erector spinae plane block at the level of T7 transverse process using 20 mL of bupivacaine 0.25% on each side + 1ml saline placebo.
Receives: Drug: Bubpivacaine
The Bubpivacaine and dexamethasonePatients in this group received bilateral ultrasound-guided erector spinae plane block at the level of T7 transverse process using 20 mL of bupivacaine 0.25% plus 1ml dexamethasone on each side
Receives: Drug: Bubpivacaine; Drug: dexamethasone
The Bubpivacaine and fentanylPatients in this group received bilateral ultrasound-guided erector spinae plane block at the level of T7 transverse process using 20 mL of bupivacaine 0.25% in addition to calculated dose of fentanyl on each side
Receives: Drug: Bubpivacaine; Drug: fentanyl

What is being measured

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

  1. first analgesic request

    signifies the initial instance when a patient asks for pain relief, commonly occurring post-surgery or during medical care, marking the first acknowledgment or complaint of discomfort prompting the need for pain medication or management.

    Measured: baseline

Secondary outcomes (1)

  1. VAS score

    a quantitative measure used in healthcare to assess and quantify pain levels. It involves a patient marking their perceived pain intensity on a 10-point or 100-point scale, typically from "no pain" to "worst pain imaginable," providing a straightforward and subjective representation of pain severity.

    Measured: baseline

Timeline

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

  1. First posted7 Nov 2023
  2. Study start1 Dec 2023 (estimated)
  3. Primary completion1 Dec 2024 (estimated)
  4. Study completion1 Jan 2025 (estimated)

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06120088
Sponsor's protocol ID
US-ESB for Postop Pain Control
Status last verified
Nov 2023
First submitted
1 Nov 2023
Last updated
7 Nov 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Gottschalk A, Durieux ME, Nemergut EC. Intraoperative methadone improves postoperative pain control in patients undergoing complex spine surgery. Anesth Analg. 2011 Jan;112(1):218-23. doi: 10.1213/ANE.0b013e3181d8a095. Epub 2010 Apr 24.

    PubMed 20418538

  • Rawal N. Current issues in postoperative pain management. Eur J Anaesthesiol. 2016 Mar;33(3):160-71. doi: 10.1097/EJA.0000000000000366.

    PubMed 26509324

  • Ohkura Y, Shindoh J, Ueno M, Iizuka T, Haruta S, Udagawa H. A new postoperative pain management (intravenous acetaminophen: Acelio(R)) leads to enhanced recovery after esophagectomy: a propensity score-matched analysis. Surg Today. 2018 May;48(5):502-509. doi: 10.1007/s00595-017-1616-5. Epub 2017 Dec 12.

    PubMed 29234960

  • Crumley S, Schraag S. The role of local anaesthetic techniques in ERAS protocols for thoracic surgery. J Thorac Dis. 2018 Mar;10(3):1998-2004. doi: 10.21037/jtd.2018.02.48.

    PubMed 29707356

  • Boisen ML, Sardesai MP, Kolarczyk L, Rao VK, Owsiak CP, Gelzinis TA. The Year in Thoracic Anesthesia: Selected Highlights From 2017. J Cardiothorac Vasc Anesth. 2018 Aug;32(4):1556-1569. doi: 10.1053/j.jvca.2018.03.001. Epub 2018 Mar 13. No abstract available.

    PubMed 29655515

  • Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

    PubMed 27501016

  • Viderman D, Dautova A, Sarria-Santamera A. Erector spinae plane block in acute interventional pain management: a systematic review. Scand J Pain. 2021 May 14;21(4):671-679. doi: 10.1515/sjpain-2020-0171. Print 2021 Oct 26.

    PubMed 33984888

  • Viderman D, Sarria-Santamera A. Erector spinae plane block in chronic pain management: a scoping review. Tumori. 2021 Oct;107(5):458-467. doi: 10.1177/0300891620985935. Epub 2021 Jan 12.

    PubMed 33430714

  • Luo D, Wan X, Liu J, Tong T. Optimally estimating the sample mean from the sample size, median, mid-range, and/or mid-quartile range. Stat Methods Med Res. 2018 Jun;27(6):1785-1805. doi: 10.1177/0962280216669183. Epub 2016 Sep 27.

    PubMed 27683581

  • Wan X, Wang W, Liu J, Tong T. Estimating the sample mean and standard deviation from the sample size, median, range and/or interquartile range. BMC Med Res Methodol. 2014 Dec 19;14:135. doi: 10.1186/1471-2288-14-135.

    PubMed 25524443

  • Knotkova H, Fine PG, Portenoy RK. Opioid rotation: the science and the limitations of the equianalgesic dose table. J Pain Symptom Manage. 2009 Sep;38(3):426-39. doi: 10.1016/j.jpainsymman.2009.06.001.

    PubMed 19735903

  • Mercadante S, Caraceni A. Conversion ratios for opioid switching in the treatment of cancer pain: a systematic review. Palliat Med. 2011 Jul;25(5):504-15. doi: 10.1177/0269216311406577.

    PubMed 21708857

  • Santonocito C, Noto A, Crimi C, Sanfilippo F. Remifentanil-induced postoperative hyperalgesia: current perspectives on mechanisms and therapeutic strategies. Local Reg Anesth. 2018 Apr 9;11:15-23. doi: 10.2147/LRA.S143618. eCollection 2018.

    PubMed 29670398

  • Abdelhamid BM, Khaled D, Mansour MA, Hassan MM. Comparison between the ultrasound-guided erector spinae block and the subcostal approach to the transversus abdominis plane block in obese patients undergoing sleeve gastrectomy: a randomized controlled trial. Minerva Anestesiol. 2020 Aug;86(8):816-826. doi: 10.23736/S0375-9393.20.14064-1. Epub 2020 May 22.

    PubMed 32449336

  • Abu Elyazed MM, Mostafa SF, Abdelghany MS, Eid GM. Ultrasound-Guided Erector Spinae Plane Block in Patients Undergoing Open Epigastric Hernia Repair: A Prospective Randomized Controlled Study. Anesth Analg. 2019 Jul;129(1):235-240. doi: 10.1213/ANE.0000000000004071.

    PubMed 30801359

Questions about this trial

What is this clinical trial studying?

An observational study of Regional Anesthesia, run by Assiut University.

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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

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

Are results available for this study?

Results are not available in the source record.

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

Contact Rehab Ahmed, master (01094878158 ext. +20, Rehabahmed5656@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

first analgesic request (time frame: baseline). 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 NCT06120088, which also lists 28 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 7 Nov 2023.

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