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).
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.
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.
- Conditions
- Pain, Postoperative
- 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 group | Role | What they receive |
|---|---|---|
| External Oblique Intercostal Plane Block group | Active comparator | The 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 group | Placebo comparator | At 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.
Total opioid consumption
All patients will receive tramadol with a patient-controlled analgesia during the postoperative period
Measured: 24 hours postoperatively
Secondary outcomes (6)
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
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
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
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
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
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.
- First posted15 Oct 2024
- Study start2 Apr 2025
- Primary completion15 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gizem Avci, Ankara Etlik City Hospital
- Investigators
- Gizem Avci, Principal investigator, Ankara Etlik City Hospital
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 35249704Elsharkawy 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of External Oblique Intercostal Plane Block Application in the Treatment of Acute Pain After Nephrectomy
- ClinicalTrials.gov ID
- NCT06639035
- Acronym / sponsor ID
- Gizem001
- Conditions
- Pain, Postoperative
- Keywords
- External Oblique Intercostal Plane Block, Nephrectomy, Postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 2 Apr 2025 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| External Oblique Intercostal Plane Block group | Active comparator | Other: External oblique intercostal plane block, Other: intavenous tramadolThe 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. |
| Control group | Placebo comparator | Other: intavenous tramadolAt 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients who have undergone nephrectomy surgery.
- Aged 18-80 years
- ASA (American Society of Anesthesiologists) I-II-III risk group that underwent nephrectomy.
Key exclusion criteria (3 listed)
- Patients under 18 or over 80 years of age
- Patients with a history of bleeding diathesis
- Patients with infections at the block site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External oblique intercostal plane blockThe external oblique intercostal plane block is applied to the patients at the end of the surgery. | Other | External Oblique Intercostal Plane Block group |
| intavenous tramadolIntravenous tramadol will be administered with patient-controlled analgesia | Other | Control group, External Oblique Intercostal Plane Block group |
Primary outcome
Total opioid consumption
Time frame: 24 hours postoperatively
All patients will receive tramadol with a patient-controlled analgesia during the postoperative period
6 secondary outcomes
Numeric rating scale (NRS)
Time frame: 0 hours postoperatively
Numeric rating scale (NRS)
Time frame: 2 hours postoperatively
Numeric rating scale (NRS)
Time frame: 4 hours postoperatively
Numeric rating scale (NRS)
Time frame: 6 hours postoperatively
Numeric rating scale (NRS)
Time frame: 12 hours postoperatively
Numeric rating scale (NRS)
Time frame: 24 hours postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2025.
- Results publication: PubMed 35249704White 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.
- Results publication: PubMed 34626112Elsharkawy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gizem Avci principal investigator
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
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.