NCT06892743

Brief Summary

Renal cell carcinoma (RCC) accounts for 2-3% of all cancers and is a common malignancy of the genitourinary tract. Open nephrectomy, performed through midline, subcostal, or flank incisions, remains a standard treatment but often results in significant postoperative pain, leading to respiratory muscle dysfunction, increased pulmonary complications, and prolonged hospital stays. Acute surgical pain arises from inflammatory responses, activation of spinal pain pathways, and muscle spasms. While postoperative pain typically improves during recovery, some patients develop chronic postsurgical pain (CPSP), lasting at least two months postoperatively. Opioids and epidural analgesia are commonly used for pain control, but their side effects and invasiveness necessitate safer, effective alternatives. Ultrasound (US)-guided peripheral nerve and field blocks have become integral to multimodal analgesia. One such technique, the \*\*external oblique intercostal plane block (EOIPB)\*\*, was introduced as a modification of fascial plane blocks, targeting anterior and lateral cutaneous nerves (T6-T10). EOIPB offers advantages over quadratus lumborum block (QLB) and erector spinae plane block (ESPB) by being performed in the supine position and providing superior midline analgesia compared to serratus intercostal plane block (SIPB). Similarly, the transversus abdominis plane (TAP) block, particularly the posterior approach, delivers analgesia from T7 to T12 by anesthetizing anterior and lateral cutaneous nerve branches. While case series suggest EOIPB may be effective for post-nephrectomy pain, comparative studies between EOIPB and posterior TAP block in open nephrectomy: Aim of the Study: To evaluate the postoperative analgesic effects of posterior transversus abdominis plane (TAP) block and external oblique intercostal plane block (EOIPB) in patients undergoing open nephrectomy under general anesthesia.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
56

participants targeted

Target at P25-P50 for not_applicable postoperative-pain

Timeline
Completed

Started Apr 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

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

March 9, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 25, 2025

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 25, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

March 9, 2025

Last Update Submit

March 22, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative morphine consumption (mg) in the first 24 hrs .

    Time elapsed from the end of the block procedure till the end of the 24 hours postoperatively

Study Arms (2)

EOIPB-Group

ACTIVE COMPARATOR
Procedure: US-guided external oblique intercostal plane block (EOIPB)

Posterior TAP - Group

ACTIVE COMPARATOR
Procedure: US-guided external oblique intercostal plane block (EOIPB)

Interventions

US Guided external oblique intercostal plane block (EOIPB) or Posterior TAP Block:

Also known as: US Guided Posterior TAP Block:
EOIPB-GroupPosterior TAP - Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients whom diagnosed as having renal carcinoma and scheduled for open nephrectomy under general anesthesia.
  • ASA class II- III.
  • Age ≥ 18 and ≤ 65 years.
  • Body mass index (BMI) less than 40kg/m2.

You may not qualify if:

  • \. Patient refusal. 2. Hepatic and renal insufficiency. 3. Unstable cardiovascular or pulmonary disease. 4. History of psychiatric and cognitive disorders. 5. Patients with known sensitivity or contraindications to the drug used. 6. Patients on regular opioid consumption.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Abeer Ahmed Mohamed

Maadi, Cairo Governorate, 11728, Egypt

RECRUITING

Kasr Alainy Faculty of Medicine - Cairo university

Cairo, 00225, Egypt

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

March 9, 2025

First Posted

March 25, 2025

Study Start

April 1, 2025

Primary Completion

October 1, 2025

Study Completion

December 1, 2025

Last Updated

March 25, 2025

Record last verified: 2025-03

Locations