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Pain, PostoperativeNCT06639035

The Effectiveness of External Oblique Intercostal Plane Block

A study testing External oblique intercostal plane block and intavenous tramadol in people with Pain, Postoperative, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).

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

The aims of the study are as follows:To examine postoperative opioid consumption.To assess the effectiveness of external oblique intercostal plane block in managing postoperative pain in nephrectomy patients.To evaluate pain at postoperative hours 0, 2, 4, 6, 12, and 24 using the Numerical Rating Scale (NRS).To assess… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Pain, Postoperative
What is being tested?
External oblique intercostal plane block and intavenous tramadol
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteTurkey (Türkiye)
Study dates
2 Apr 2025to 30 May 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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients who have undergone nephrectomy surgery.
  • Aged 18-80 years
  • ASA (American Society of Anesthesiologists) I-II-III risk group that underwent nephrectomy.

Who cannot join

  • Patients under 18 or over 80 years of age
  • Patients with a history of bleeding diathesis
  • Patients with infections at the block site

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Gizem Avcı

    Ankara

Other trials in Turkey (Türkiye)

About this study

Official title: The Effectiveness of External Oblique Intercostal Plane Block Application in the Treatment of Acute Pain After Nephrectomy

The aims of the study are as follows:To examine postoperative opioid consumption.To assess the effectiveness of external oblique intercostal plane block in managing postoperative pain in nephrectomy patients.To evaluate pain at postoperative hours 0, 2, 4, 6, 12, and 24 using the Numerical Rating Scale (NRS).To assess pain increase with movement and effort at postoperative hours 0, 2, 4, 6, 12, and 24 using NRS.

Read the detailed description

The Effectiveness of External Oblique Intercostal Plane Block in the Management of Acute Pain Following NephrectomyNephrectomy is a commonly performed surgical procedure in urology due to benign or malignant reasons. Depending on the underlying pathology and the patient, the surgical procedure can vary in scale, including simple nephrectomy, partial nephrectomy, and radical nephrectomy, and may be performed either openly or laparoscopically. Postoperative pain can prolong the patient's hospital stay and impair comfort. Due to pain, patients may develop atelectasis and hypertension after surgery, leading to an increased need for narcotic analgesia. The increased demand for narcotic analgesics according to patients' age and characteristics can affect renal functions and may not improve patient comfort due to nausea and vomiting. Regional anesthesia of the torso and abdominal wall has generally focused on epidural analgesia. However, the increased use of minimally invasive laparoscopic techniques, the significance of postoperative anticoagulation regimens, and early ambulation have led to changes in analgesia selection. Although transversus abdominis plane blocks and rectus sheath blocks are frequently applied, their inability to adequately manage abdominal pain alone, along with the challenges posed in obese patients, has led to a recent shift towards the external oblique intercostal plane block.The application of the EOIP block involves the patient being in a supine position, with either the clavicle or mid-axillary line palpated to locate the 6th rib. An ultrasound probe is placed 1-2 cm lateral to the midclavicular line over the 6th rib. Under aseptic conditions, a 22-gauge 25-50 mm block needle is advanced to the 6th rib using the in-plane technique. Two ml of saline is injected for hydrodissection to ensure accurate placement. Avoiding subperiosteal injection, hydrodissection is performed between the external oblique muscle and the 6th rib. Subsequently, 20-30 ml of 0.25% bupivacaine is injected into this area. The block is then repeated on the other side.

In our clinic, a multimodal analgesia approach is preferred for patients undergoing nephrectomy. Plan blocks (administered to every suitable and consenting patient) are used in conjunction with intravenous analgesic agents. Blocks are routinely applied to patients undergoing nephrectomy, who are monitored in the postoperative intensive care unit. Our study will include suitable patients who have undergone nephrectomy and received this block. The anesthesiologist managing anesthesia will be different from the anesthetist monitoring pain. Our study is entirely observational, and no randomization will be conducted. There will be no intervention in either analgesia or anesthesia management. Patients who consent to participate will be included in the study in the recovery room after the block is administered.

The aims of the study are as follows:To examine postoperative opioid consumption.To assess the effectiveness of external oblique intercostal plane block in managing postoperative pain in nephrectomy patients.To evaluate pain at postoperative hours 0, 2, 4, 6, 12, and 24 using the Numerical Rating Scale (NRS).To assess pain increase with movement and effort at postoperative hours 0, 2, 4, 6, 12, and 24 using NRS.

Being tested
External oblique intercostal plane block, intavenous tramadol
Keywords
External Oblique Intercostal Plane Block, Nephrectomy, Postoperative pain
Medical subject headings
Pain, Postoperative

What participants receive

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

  • External oblique intercostal plane blockOther

    The external oblique intercostal plane block is applied to the patients at the end of the surgery.

  • intavenous tramadolOther

    Intravenous tramadol will be administered with patient-controlled analgesia

Study groups in NCT06639035
Study groupRoleWhat they receive
External Oblique Intercostal Plane Block groupActive comparatorThe External Oblique Intercostal Plane Block was administered bilaterally with local anesthetic mixture of 20 ml volume (10 ml bupivacaine 0.5%, 5 ml lidocaine 2% and 5 ml isotonic saline) after completion of surgery.
Receives: Other: External oblique intercostal plane block; Other: intavenous tramadol
Control groupPlacebo comparatorAt the end of the surgery, an isotonic solution was administered to the control group patients by inserting a needle through the entry site compatible with the external oblique intercostal block.
Receives: Other: intavenous tramadol

What is being measured

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

  1. Total opioid consumption

    All patients will receive tramadol with a patient-controlled analgesia during the postoperative period

    Measured: 24 hours postoperatively

Secondary outcomes (6)
  1. Numeric rating scale (NRS)

    NRS range will from 0- 10 with 0 being no pain and 10 the worst pain possible.

    Measured: 0 hours postoperatively

  2. Numeric rating scale (NRS)

    NRS range will from 0- 10 with 0 being no pain and 10 the worst pain possible.

    Measured: 2 hours postoperatively

  3. Numeric rating scale (NRS)

    NRS range will from 0- 10 with 0 being no pain and 10 the worst pain possible.

    Measured: 4 hours postoperatively

  4. Numeric rating scale (NRS)

    NRS range will from 0- 10 with 0 being no pain and 10 the worst pain possible.

    Measured: 6 hours postoperatively

  5. Numeric rating scale (NRS)

    NRS range will from 0- 10 with 0 being no pain and 10 the worst pain possible.

    Measured: 12 hours postoperatively

  6. Numeric rating scale (NRS)

    NRS range will from 0- 10 with 0 being no pain and 10 the worst pain possible.

    Measured: 24 hours postoperatively

Timeline

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

  1. First posted15 Oct 2024
  2. Study start2 Apr 2025
  3. Primary completion15 May 2025
  4. Study completion30 May 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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06639035
Sponsor's protocol ID
Gizem001
Status last verified
Jun 2025
First submitted
10 Oct 2024
Last updated
29 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • White L, Ji A. External oblique intercostal plane block for upper abdominal surgery: use in obese patients. Br J Anaesth. 2022 May;128(5):e295-e297. doi: 10.1016/j.bja.2022.02.011. Epub 2022 Mar 3. No abstract available.

    PubMed 35249704
  • Elsharkawy H, Kolli S, Soliman LM, Seif J, Drake RL, Mariano ER, El-Boghdadly K. The External Oblique Intercostal Block: Anatomic Evaluation and Case Series. Pain Med. 2021 Nov 26;22(11):2436-2442. doi: 10.1093/pm/pnab296.

    PubMed 34626112

Questions about this trial

What is this clinical trial studying?

A study testing External oblique intercostal plane block and intavenous tramadol in people with Pain, Postoperative, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).

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 3 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 29 Jun 2025. 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 Turkey (Türkiye). 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.

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 opioid consumption (time frame: 24 hours postoperatively). 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 NCT06639035, which also lists 2 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 29 Jun 2025.

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