The Analgesic Efficacy of Ultrasound Guided Transversalis Fascia Plane Block in Inguinal Lymph Node Dissection

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

About this trial

Pain accompanying Inguinal lymph node dissection triggers a complex stress response leading to impairment of pulmonary, immunological and metabolic function. Opioids are the current gold standard drug for postoperative pain relief, however exposure to large doses lead to multiple side effects of varying significance such as nausea, vomiting, dizziness, constipation, respiratory depression, hypoventilation and sleep disordered breathing. Therefore, strategies other than opioids are recommended without sacrificing proper and effective analgesia, especially in cancer patients who are more susceptible to tolerance and addiction.

Transversalis Fascia Plane Block is used in patients undergoing various surgeries like iliac crest bone harvesting, appendicectomy, cecostomy and inguinal hernia repair, often in combination with TAP block. The initial description of TFPB was with patients in the supine position, with a linear array or curvilinear probe placed between the iliac crest and the costal margin. The external oblique, internal oblique and transversus abdominis muscles and the transversus aponeurosis are identified. The entry of the needle has to be in-plane, from the anterior aspect, and after traversing through the deep surface of the transversus abdominis muscle, local anesthetic is injected to separate the transversalis fascia from the transversus muscle. Studies have demonstrated that this intervention blocks the proximal branches of T12 and L1 and to a lesser extent T11 in the plane between the transversus abdominis muscle and the transversalis fascia. Since its initial description, ultrasound (US)-guided TFPB has been explored in many randomized controlled trials for patients undergoing iliac crest bone harvesting, lower segment caesarean section (LSCS), inguinal hernia repair and hip surgeries.

Eligibility criteria

This trial accepts 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 platelets count below 50,000 or an INR>1.6.

Unstable cardiovascular disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • transversalis fascia plane block and surgical sit local anesthetic infiltration

    Procedure/Surgery

    inguinal fascial plane block and surgical site local anesthetic infiltration

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: ultrasound guided transversalis fascia plane block (TFPB).Active comparator 1 intervention
Group B: surgical incision site infiltration with the local anesthetics.Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Pain scores using Visual analogue score

Pain scores using Visual analogue score (VAS) (0 mm = no pain to 10mm = worst pain imaginable) at predetermined time intervals (0,1, 2, 4,6, 12 and 24h) postoperative.

Time frame
24 hours after the surgery

Secondary outcomes

1

Total intra-operative fentanyl consumption

the rescue analgesia will be administered intra-operative by fentanyl IV and the total fentanyl used will be recorded and compared between the groups

Time frame
2-3 hours (Surgery time) surgery
2

1st time opioids requested post-operative.

In case of postoperative pain recorded, rescue analgesia will be provided as IV morphine (3 mg) then continuous infusion of morphine through Patient Controlled Analgesia ( PCA ) to keep the VAS scores\<3. The total 24-hour morphine consumption will be recorded for every patient.

Time frame
24 hours after the surgery
3

Total post-operative morphine consumption.

The total 24-hour morphine consumption will be recorded for every patient post operative.

Time frame
24 hours after the surgery
4

Changes and stability in Mean Arterial Blood Pressure (MAP)

Change in Mean Arterial Blood Pressure (MAP) in mmHg

Time frame
every 15 minutes during the surgery then at 1, 2, 4, 8, 12, 16, 20 and 24 hours postoperatively

Other outcomes

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