Comparison Between External Oblique Intercostal Plane Block and the Transversus Abdominis Plane Block in Paraumbilical Hernia Repair as Analgesia for Intraoperative and Postoperative Pain.

NCT06412406 | Not Yet Recruiting

• 1 other identifier: paraumbilical hernia
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief Summary

AIM OF STUDY: Comparison between effect of external oblique intercostal plane block and the Oblique subcostal transversus abdominis plane block in paraumbilical hernia repair as analgesia for intraoperative and postoperative pain.

Conditions

Paraumbilical Hernia

Outcome Measures

Primary Outcomes (1)

• The effect between external oblique intercostal plane block and the transversus abdominis plane block in paraumbilical hernia repair as analgesia for intraoperative and postoperative pain according to numeric rating score (NRS)

  numeric rating scale : from 0 to 10 0 : no pain 1 - 3 : mild pain 4 - 6 : moderate pain 7 - 9 : severe pain 10 : worst pain possible

  baseline

Secondary Outcomes (4)

• time of the first opioid request

  baseline

• Heart rate

  baseline

• Mean arterial blood pressure

  baseline

• time to start ambulation

  baseline

Study Arms (2)

Transversus abdominis plane (TAP) block

ACTIVE COMPARATOR

Group A will include 31 patients to receive TAP block with 20 ml volume on each side (0.25 % bupivacaine)

Procedure: Transversus abdominis plane (TAP) block

External Oblique intercostal (EOI) block

ACTIVE COMPARATOR

Group B will include 31 patients to receive EOI block with 20 ml volume on each side ( 0.25% bupivacaine)

Procedure: External Oblique Intercostal (EOI) block

Interventions

External Oblique Intercostal (EOI) block PROCEDURE

EOI block technique A linear ultrasound transducer placed in the sagittal plane between the midclavicular and anterior axillary lines at the level of sixth rib, The transducer was then rotated so the cranial end was directed slightly medially and the caudal end laterally to produce a paramedian sagittal oblique view with a short-axis view of the ribs, The following structures were identified, from superficial to deep: subcutaneous tissue, external oblique muscle, intercostal muscles between ribs, pleura, and lung. The skin entry point for the injection was cranial to the sixth rib level just medial to the anterior axillary line, with ultrasound opaque needle advanced in plane from a superomedial-to-inferolateral direction, through the external oblique muscle hydrodissecting the tissue plane between the sixth and seventh ribs, and then the needle was directed caudally toward the eighth rib. and inject 20 ml volume of (0.25 % bupivacaine).

External Oblique intercostal (EOI) block

Transversus abdominis plane (TAP) block PROCEDURE

TAP block technique: abdominal skin will be prepared and covered with sterile drapes. The needle can be introduced by multiple punctures along the oblique subcostal line from the xiphoid process towards the anterior part of the iliac crest (18) . Thus, LA will be injected in the TAP along this line provides both upper and lower abdominal wall analgesia. The OSCTAP block more consistently covers L1 dermatome. After negative aspiration, a test injection with 1 ml of 0.9% normal saline will be performed to confirm the needle location. and ingect 20 ml volume of (0.25 % bupivacaine). If the intended sensation will not decreased in surgical dermatomes after 30 min, the patient will be regarded to have a failed block and will be excluded from the study.

Transversus abdominis plane (TAP) block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 65 years with a body mass index (BMI) of 18-35 kg/m2
• patients with the American Society of Anesthesiologists (ASA) physical status I/II
• Patients scheduled for elective paraumbilical hernia

You may not qualify if:

• Known hypersensitivity to the study drugs. 2-Body Mass Index \> 40 kg/m2. 3- Inability to accurately describe postoperative pain to investigators. 4-Opioid tolerance or dependence. 5-Preexisting history of chronic pain. 6-History of renal, liver, cardiac, neuropsychiatric disorder problems. 7-Bleeding or coagulation abnormality. 8-Patients who received any analgesic 24 h before surgery 9-Patients who have difficulty understanding the study protocol

Sponsors & Collaborators

• Assiut University: lead

Related Publications (17)

• Tsai HC, Yoshida T, Chuang TY, Yang SF, Chang CC, Yao HY, Tai YT, Lin JA, Chen KY. Transversus Abdominis Plane Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:8284363. doi: 10.1155/2017/8284363. Epub 2017 Oct 31.

  PMID: 29226150 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

• Elsharkawy H, Maniker R, Bolash R, Kalasbail P, Drake RL, Elkassabany N. Rhomboid Intercostal and Subserratus Plane Block: A Cadaveric and Clinical Evaluation. Reg Anesth Pain Med. 2018 Oct;43(7):745-751. doi: 10.1097/AAP.0000000000000824.

  PMID: 30169476 BACKGROUND

• Desai N, El-Boghdadly K, Albrecht E. Epidural vs. transversus abdominis plane block for abdominal surgery - a systematic review, meta-analysis and trial sequential analysis. Anaesthesia. 2021 Jan;76(1):101-117. doi: 10.1111/anae.15068. Epub 2020 May 8.

  PMID: 32385856 BACKGROUND

• Qin C, Liu Y, Xiong J, Wang X, Dong Q, Su T, Liu J. The analgesic efficacy compared ultrasound-guided continuous transverse abdominis plane block with epidural analgesia following abdominal surgery: a systematic review and meta-analysis of randomized controlled trials. BMC Anesthesiol. 2020 Feb 28;20(1):52. doi: 10.1186/s12871-020-00969-0.

  PMID: 32111162 BACKGROUND

• Macrae WA. Chronic post-surgical pain: 10 years on. Br J Anaesth. 2008 Jul;101(1):77-86. doi: 10.1093/bja/aen099. Epub 2008 Apr 22.

  PMID: 18434337 BACKGROUND

• Gan TJ, Diemunsch P, Habib AS, Kovac A, Kranke P, Meyer TA, Watcha M, Chung F, Angus S, Apfel CC, Bergese SD, Candiotti KA, Chan MT, Davis PJ, Hooper VD, Lagoo-Deenadayalan S, Myles P, Nezat G, Philip BK, Tramer MR; Society for Ambulatory Anesthesia. Consensus guidelines for the management of postoperative nausea and vomiting. Anesth Analg. 2014 Jan;118(1):85-113. doi: 10.1213/ANE.0000000000000002.

  PMID: 24356162 BACKGROUND

• Elsharkawy H, Pawa A, Mariano ER. Interfascial Plane Blocks: Back to Basics. Reg Anesth Pain Med. 2018 May;43(4):341-346. doi: 10.1097/AAP.0000000000000750.

  PMID: 29561295 BACKGROUND

• Sondekoppam RV, Brookes J, Morris L, Johnson M, Ganapathy S. Injectate spread following ultrasound-guided lateral to medial approach for dual transversus abdominis plane blocks. Acta Anaesthesiol Scand. 2015 Mar;59(3):369-76. doi: 10.1111/aas.12459. Epub 2015 Jan 13.

  PMID: 25582299 BACKGROUND

• Borglum J, Jensen K, Christensen AF, Hoegberg LC, Johansen SS, Lonnqvist PA, Jansen T. Distribution patterns, dermatomal anesthesia, and ropivacaine serum concentrations after bilateral dual transversus abdominis plane block. Reg Anesth Pain Med. 2012 May-Jun;37(3):294-301. doi: 10.1097/AAP.0b013e31824c20a9.

  PMID: 22476239 BACKGROUND

• Tulgar S, Senturk O, Selvi O, Balaban O, Ahiskalioglu A, Thomas DT, Ozer Z. Perichondral approach for blockage of thoracoabdominal nerves: Anatomical basis and clinical experience in three cases. J Clin Anesth. 2019 May;54:8-10. doi: 10.1016/j.jclinane.2018.10.015. Epub 2018 Oct 31. No abstract available.

  PMID: 30388604 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

• 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

• Cosarcan SK, Ercelen O. The analgesic contribution of external oblique intercostal block: Case reports of 3 different surgeries and 3 spectacular effects. Medicine (Baltimore). 2022 Sep 9;101(36):e30435. doi: 10.1097/MD.0000000000030435.

  PMID: 36086688 BACKGROUND

• Karcioglu O, Topacoglu H, Dikme O, Dikme O. A systematic review of the pain scales in adults: Which to use? Am J Emerg Med. 2018 Apr;36(4):707-714. doi: 10.1016/j.ajem.2018.01.008. Epub 2018 Jan 6.

  PMID: 29321111 BACKGROUND

• Marhofer P, Harrop-Griffiths W, Kettner SC, Kirchmair L. Fifteen years of ultrasound guidance in regional anaesthesia: part 1. Br J Anaesth. 2010 May;104(5):538-46. doi: 10.1093/bja/aeq069. Epub 2010 Apr 2.

  PMID: 20364022 BACKGROUND

• Soliz JM, Lipski I, Hancher-Hodges S, Speer BB, Popat K. Subcostal Transverse Abdominis Plane Block for Acute Pain Management: A Review. Anesth Pain Med. 2017 Oct 20;7(5):e12923. doi: 10.5812/aapm.12923. eCollection 2017 Oct.

  PMID: 29696110 BACKGROUND

MeSH Terms

Interventions

Dental Occlusion

Intervention Hierarchy (Ancestors)

Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Officials

• Nawal A Gadelrab, Professor

  Assiut University

  STUDY CHAIR

• Abdelrahim M Mohamed, Professor

  Assiut University

  STUDY CHAIR

• Mohamed G Hassan, Resident

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed G Hassan, Resident

CONTACT

01068885672; resho860@gmail.com

Abdelrahim M Mohamed, Professor

CONTACT

01000032655; arawamyyy@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: May 14, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): October 28, 2026
• Study Completion (Estimated): December 29, 2026
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share