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

Regional Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06120088
• Other study ID #: US-ESB for Postop Pain Control
• Status: Not yet recruiting
• Start date: December 1, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: November 2023
• Source: Assiut University
• Contact: Rehab Ahmed, master
• Phone: 01094878158
• Email: Rehabahmed5656[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: January 1, 2025
• Est. primary completion date: December 1, 2024
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Pain, Postoperative
• Regional Anesthesia

Intervention

Drug:
• Bubpivacaine
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.
• dexamethasone
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.
• fentanyl
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (28)

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. — View Citation

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. — View Citation

Altiparmak B, Korkmaz Toker M, Uysal AI, Gumus Demirbilek S. Comparison of the efficacy of erector spinae plane block performed with different concentrations of bupivacaine on postoperative analgesia after mastectomy surgery: ramdomized, prospective, double blinded trial. BMC Anesthesiol. 2019 Mar 4;19(1):31. doi: 10.1186/s12871-019-0700-3. — View 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. — View Citation

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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. — View Citation

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Hamed MA, Goda AS, Basiony MM, Fargaly OS, Abdelhady MA. Erector spinae plane block for postoperative analgesia in patients undergoing total abdominal hysterectomy: a randomized controlled study original study. J Pain Res. 2019 Apr 30;12:1393-1398. doi: 10.2147/JPR.S196501. eCollection 2019. — View Citation

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Kamel AAF, Amin OAI, Ibrahem MAM. Bilateral Ultrasound-Guided Erector Spinae Plane Block Versus Transversus Abdominis Plane Block on Postoperative Analgesia after Total Abdominal Hysterectomy. Pain Physician. 2020 Jul;23(4):375-382. — View Citation

Kim D, Kim JM, Choi GS, Heo G, Kim GS, Jeong JS. Ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic liver resection: A prospective, randomised controlled, patient and observer-blinded study. Eur J Anaesthesiol. 2021 Aug 1;38(Suppl 2):S106-S112. doi: 10.1097/EJA.0000000000001475. — View Citation

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Prasad MK, Varshney RK, Jain P, Choudhary AK, Khare A, Jheetay GS. Postoperative analgesic efficacy of fluoroscopy-guided erector spinae plane block after percutaneous nephrolithotomy (PCNL): A randomized controlled study. Saudi J Anaesth. 2020 Oct-Dec;14(4):480-486. doi: 10.4103/sja.SJA_26_20. Epub 2020 Sep 24. — View Citation

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

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. — View Citation

Temirov T, Ben-David B, Mustafin A, Viderman D. Erector Spinae Plane Block in Management of Pain After Kidney Transplantation. Pain Med. 2019 May 1;20(5):1053-1054. doi: 10.1093/pm/pny221. No abstract available. — View Citation

Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15. — View Citation

Viderman D, Ben-David B, Sarria-Santamera A. Analysis of bupivacaine and ropivacaine-related cardiac arrests in regional anesthesia: A systematic review of case reports. Rev Esp Anestesiol Reanim (Engl Ed). 2021 Oct;68(8):472-483. doi: 10.1016/j.redare.2020.10.005. Epub 2021 Sep 17. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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Zhang Y, Liu T, Zhou Y, Yu Y, Chen G. Analgesic efficacy and safety of erector spinae plane block in breast cancer surgery: a systematic review and meta-analysis. BMC Anesthesiol. 2021 Feb 20;21(1):59. doi: 10.1186/s12871-021-01277-x. — View Citation

* Note: There are 28 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline
Secondary	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.	baseline