NCT06639035

Brief 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 pain increase with movement and effort at postoperative hours 0, 2, 4, 6, 12, and 24 using NRS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
6 months until next milestone

Study Start

First participant enrolled

April 2, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

June 29, 2025

Status Verified

June 1, 2025

Enrollment Period

1 month

First QC Date

October 10, 2024

Last Update Submit

June 25, 2025

Conditions

Pain, Postoperative

Keywords

External Oblique Intercostal Plane BlockNephrectomyPostoperative pain

Outcome Measures

Primary Outcomes (1)

  • Total opioid consumption

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

    24 hours postoperatively

Secondary Outcomes (6)

  • Numeric rating scale (NRS)

    0 hours postoperatively

  • Numeric rating scale (NRS)

    2 hours postoperatively

  • Numeric rating scale (NRS)

    4 hours postoperatively

  • Numeric rating scale (NRS)

    6 hours postoperatively

  • Numeric rating scale (NRS)

    12 hours postoperatively

  • +1 more secondary outcomes

Study Arms (2)

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.

Other: External oblique intercostal plane blockOther: 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.

Other: intavenous tramadol

Interventions

External oblique intercostal plane blockOTHER

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

External Oblique Intercostal Plane Block group
intavenous tramadolOTHER

Intravenous tramadol will be administered with patient-controlled analgesia

Control groupExternal Oblique Intercostal Plane Block group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gizem Avcı

Ankara, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 35249704RESULT

  • 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.

    PMID: 34626112RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Gizem Avci

    Ankara Etlik City Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 10, 2024

First Posted

October 15, 2024

Study Start

April 2, 2025

Primary Completion

May 15, 2025

Study Completion

May 30, 2025

Last Updated

June 29, 2025

Record last verified: 2025-06

Locations

TU(1)