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Ultrasound Guided Rhomboid Intercostal Subserratus Plane Block vs Erector Spinae Plane Block in Open Nephrectomy

Ultrasound Guided Rhomboid Intercostal Subserratus Plane Block Versus Erector Spinae Plane Block in Open Nephrectomy. Randomized Controlled Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05822011
Enrollment
42
Registered
2023-04-20
Start date
2023-04-20
Completion date
2025-05-15
Last updated
2025-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Operative Pain

Keywords

Rhomboid intercostal block

Brief summary

Our aim is to measure the efficacy of rhomboid intercostal subserratus plane block and erector spinae plane block in patients undergoing open nephrectomy

Detailed description

Open nephrectomy incision is associated with a high incidence of intense immediate postoperative pain and chronic pain the months following surgery. Regional anesthesia techniques are commonly recommended for pain management in open nephrectomy as they decrease parenteral opioid requirements and improve patient satisfaction. Rhomboid intercostal subserratus plane block (RISS) is considered a novel approach for chest wall and upper abdominal analgesia, initially showed promising results, first reported in 2016. Erector Spinae Plane block (ESB), was initially described in 2016 for analgesia in thoracic neuropathic pain. It has also been widely used in both adults and children at different levels for different indications. Epidural analgesia is the gold standard for perioperative analgesia in open surgery.

Interventions

PROCEDUREErector spinae plane block

Fascial plane block

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. Type of surgery; open nephrectomy. 2. Physical status ASA II, III. 3. Body mass index (BMI): \> 20 kg/ m2 and \< 35 kg/ m2.

Exclusion criteria

1. Patient refusal. 2. Local infection at the puncture site. 3. Severe respiratory or cardiac disorders. 4. Advanced liver or kidney disease. 5. History of psychological disorders and/or chronic pain. 6. Contraindication to regional anesthesia e.g. local sepsis, pre- existing peripheral neuropathies and coagulopathy. 7. Patients with known sensitivity or contraindication to amide local anesthetics used in the study.

Design outcomes

Primary

MeasureTime frameDescription
The total amount of morphine consumption in (mg)first 24 hours postoperatively.amount of morphine in mg consumed in 1st 24 hours

Secondary

MeasureTime frameDescription
Total amount fentanyl in (microgram)intra operative durationtotal amount of intraoperative fentanyl consumed in micrograms
Change in heart rate in (beat/min)From just before induction till 24 hours post operativelyReadings will be taken as baseline preoperative reading, immediately after surgical incision and at 15-minute intervals intraoperatively and 30 minutes,2,4,8,12,16 and 24 hours postoperatively
Time of first request of analgesiafirst 24 hours postoperativelycalculated from the time of complete injection of local anesthetics till the numerical pain rating scale (NRS) is ≥3.(NRS requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable)
Numeric Pain Rating Scalefirst 24 hours postoperativelyA numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable
Nausea and vomiting Scoresfirst 24 hours postoperativelyNausea and vomiting Scores using a four-point verbal scale. (None =no nausea, mild =nausea but no vomiting, moderate=vomiting one attack, severe =vomiting \>one
Change in mean arterial blood pressure in (mmHg)From just before induction till 24 hours post operativelyReadings will be taken as baseline preoperative reading, immediately after surgical incision and at 15-minute intervals intraoperatively and 30 minutes,2,4,8,12,16 and 24 hours postoperatively

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026