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Paraumbilical HerniaNCT06412406

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

A study testing External Oblique Intercostal (EOI) block and Transversus abdominis plane (TAP) block in people with Paraumbilical Hernia, 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

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

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Paraumbilical Hernia
What is being tested?
External Oblique Intercostal (EOI) block and Transversus abdominis plane (TAP) block
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
62 participants
Where
1 siteEgypt
Study dates
28 Feb 2024to 10 Aug 2025
Phase
Interventional
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 1-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

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Faculty of Medicine Assuit University

    Asyut

Other trials in Egypt

About this study

Official title: Comparison Between External Oblique Intercostal Plane Block and the Subcostal Transversus Abdominis Plane Block Regarding Intraoperative and Postoperative Analgesia Inpatients Undergoing Paraumbilical Hernia Repair Surgery.

AIM OF STUDY:

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

Read the detailed description

A paraumbilical hernia is a hole in the connective tissue of the abdominal wall in the midline with close approximation to the umbilicus. If the hole is large enough there can be protrusion of the abdominal contents, including omental fat and/or bowel. These defects are usually congenital and are not noticed until they slowly enlarge over an individual's life time and abdominal contents herniate through the hole creating either pain or a visible lump on the abdominal wall. If abdominal contents get incarcerated (or stuck) in the hole this can cause pain. If the abdominal contents become strangulated by losing their blood supply from pinching or twisting those tissue will die. If it is omental fat this will cause pain and could potentially lead to an infection. If the strangulated contents are bowel then in addition to pain the individual will develop a bowel obstruction. And if the dead bowel is not surgically removed in an emergent fashion the condition could be fatal.

Postoperative pain is the major obstacle for early postoperative ambulation and increases the risk of venous thromboembolism and respiratory complications and prolongs the hospital stay. This pain is routinely managed using opiates, which are associated with several side effects, including excessive sedation and postoperative nausea and vomiting (PONV) which may increase hospital stay durations. Transversus abdominis plane (TAP) block is a regional anesthetic technique that has gradually become an alternative for postoperative pain control during laparoscopic abdominal surgeries. It involves the infusion of local anesthetic into the fascial plane of the abdominal wall.

the subcostal transversus abdominis plane block (TAP) targets the upper abdominal wall.

The EOI block represents an important modification that cover the upper lateral abdominal wall.

subcostal transversus abdominis plane (SCTAP) 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. The SCTAP has been described that can be performed to provide analgesia for abdominal surgery extending above the umbilicus.

Being tested
External Oblique Intercostal (EOI) block, Transversus abdominis plane (TAP) block

What participants receive

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

  • External Oblique Intercostal (EOI) blockProcedure or surgery

    For the external oblique intercostal plane block, patients were positioned supine. After skin disinfection and sterile preparation, a high-frequency linear ultrasound probe was used. The probe was placed in a longitudinal parasagittal orientation at the level of the ninth rib between the midclavicular and anterior axillary lines. A 21-gauge, 10-cm needle was advanced using an in-plane technique at a shallow angle until the fascial plane deep to the external oblique muscle above the ninth rib was reached. After negative aspiration, 20 mL of 0.25% bupivacaine was injected slowly on each side

  • Transversus abdominis plane (TAP) blockProcedure or surgery

    For the subcostal transversus abdominis plane block, patients were positioned supine with adequate exposure of the abdominal wall. After sterile preparation, a high-frequency linear ultrasound probe was placed below the costal margin near the midclavicular line. A 21-gauge, 10-cm needle was advanced under ultrasound guidance until the transversus abdominis plane was reached (between the rectus abdominus and transversus abdominus muscle. After negative aspiration to exclude intravascular or intraperitoneal placement, 20 mL of 0.25% bupivacaine was injected slowly on each side

Study groups in NCT06412406
Study groupRoleWhat they receive
Transversus abdominis plane (TAP) blockActive comparatorGroup A will include 31 patients to receive TAP block with 20 ml volume on each side (0.25 % bupivacaine)
Receives: Procedure: Transversus abdominis plane (TAP) block
External Oblique intercostal (EOI) blockActive comparatorGroup B will include 31 patients to receive EOI block with 20 ml volume on each side ( 0.25% bupivacaine)
Receives: Procedure: External Oblique Intercostal (EOI) block

What is being measured

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

  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

    Measured: baseline

Secondary outcomes (4)
  1. time of the first opioid request

    time of the first opioid request all over 24 hours postoperatively.

    Measured: baseline

  2. Heart rate

    heart rate will be recorded at time 0 then every 15 minutes in the first 2 hours, then at 6, 12, 24 hours postoperatively.

    Measured: baseline

  3. Mean arterial blood pressure

    mean arterial blood pressure will be recorded at time 0 then every 15 minutes in the first 2 hours, then at 6, 12, 24 hours postoperatively.

    Measured: baseline

  4. time to start ambulation

    time of the patient first movement will be recorded

    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 posted14 May 2024
  2. Study start28 Feb 2024
  3. Primary completion10 Aug 2025
  4. Study completion10 Aug 2025

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 N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06412406
Sponsor's protocol ID
paraumbilical hernia
Status last verified
Aug 2026
First submitted
23 Feb 2024
Last updated
11 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29226150
  • 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
  • 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.

    PubMed 30169476
  • 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.

    PubMed 32385856
  • 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.

    PubMed 32111162
  • 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.

    PubMed 18434337
  • 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.

    PubMed 24356162
  • 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.

    PubMed 29561295
  • 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.

    PubMed 25582299
  • 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.

    PubMed 22476239
  • 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.

    PubMed 30388604
  • 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
  • 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
  • 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.

    PubMed 36086688
  • 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.

    PubMed 29321111

Questions about this trial

What is this clinical trial studying?

A study testing External Oblique Intercostal (EOI) block and Transversus abdominis plane (TAP) block in people with Paraumbilical Hernia, 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 3 inclusion and 1 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 11 Aug 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. 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?

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?

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) (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 NCT06412406, which also lists 17 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 11 Aug 2026.

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