Ultrasound Guided- Chemical Rectus Sheath Block for Chronic Pain After Abdominal Midline Incision in Cancer Surgeries

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorNational Cancer Institute, Egypt

About this trial

The aim of this study is to evaluate peri-operative analgesia efficacy of ultrasound guided transversalis fascia plane block in cancer patients undergoing inguinal lymph node dissection

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

American Society of Anesthesiologists (ASA) class I and II.

Age ≥ 18 and ≤ 65 Years.

Cancer patients for inguinal lymph node dissection.

Body mass index (BMI): > 20 kg/m2 and < 40 kg/m2.

Disqualifiers

Patient refusal.

Local infection at the puncture site.

Coagulopathies with platelet count below 50,000 or an INR>1.6.

Unstable cardiovascular disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Saline 0.9%

    Drug

    Patients will receive a sham block was performed using an equivalent volume of normal saline 0.9%.

  • Transversalis fascia plane block

    Drug

    Patients will receive ultrasound guided transversalis fascia plane block.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Group 1Sham comparator 1 intervention
Group B: Group 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Degree of pain

Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS) score. NRS (0 represents "no pain" while 10 represents "the worst pain imaginable").

Time frame
24 hours postoperatively

Secondary outcomes

1

Total fentanyl consumption

When elevation of Heart rate (HR) or mean arterial blood pressure (MAP) ≥ 20% of the baseline will be treated by fentanyl 0.5 μg / kg.

Time frame
Intraoperatively
2

Total opioid consumption

The patients will be observed in the postoperative care unit for 2 h, and rescue analgesia will be provided in the form of intravenous morphine 3 mg with maximum dose of 0.1 mg/kg/dose (max 0.3 mg/kg/day) boluses if the pain score \>3. The total amount of morphine given in 24 h will be recorded for every patient.

Time frame
24 hours postoperatively
3

Mean arterial pressure

Mean arterial pressure will be recorded before injection of the local anesthetics to be defined as a baseline reading and after injection then will be recorded immediately before and after surgical incision, at 30 min intervals intraoperatively, and immediately postoperative and at 2, 4, 6, 12 and 24 h postoperatively.

Time frame
24 hours postoperatively
4

Heart rate

Heart rate will be recorded before injection of the local anesthetics to be defined as a baseline reading and after injection then will be recorded immediately before and after surgical incision, at 30 min intervals intraoperatively, and immediately postoperative and at 2, 4, 6, 12 and 24 h postoperatively.

Time frame
24 hours postoperatively

Other outcomes

Sponsors and contacts

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