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Not yet recruiting NCT07113600

Erector Spinae Plane Block Versus Iliohypogastric/Ilioinguinal Nerve Block for Post-Hysterctomy Pain Relief

No phase Interventional Postoperative Pain, Acute

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nerve Block.
Who it may be relevant to
Registry conditions: Postoperative Pain, Acute. Basic parameters: from 35 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Randomized Comparative Study Between Ultrasound Guided Erector Spinae Plane Block and Ultrasound Guided Iliohypogastric/ Ilioinguinal Nerve Block for Postoperative Pain Relief in Female Patients Undergoing Open Hysterectomy

Overview

The goal of this clinical trial is to compare the degree of pain relief between two techniques of regional anesthesia given to ladies undergoing hysterectomy under general anesthesia. One group of patients will have a local anesthetic injected between muscle layers in their back (ultrasound guided Erector Spinae plane Block). The other group will have a local anesthetic injected around specific nerves in their abdomen (ultrasound guided Ilio-hypogastric / ilio-inguinal nerve block ). Researchers will compare the duration of postoperative pain relief , the degree of pain relief and any possible side effects of either techniques.

Detailed description

The use of ultrasound for the placement of peripheral nerve blocks has received a great deal of attention in anesthesiology literature as well as clinical practice. Advantages of ultrasound-guided regional anesthesia include easy learning, fast onset, higher success rates, more complete blocks, using lower local anesthetic volumes and more safety. Good postoperative analgesia can prevent morbidity associated with abdominal hysterectomy by allowing pain-free, early ambulation and decreasing the risks of long hospital stay such as thrombo-embolism, and other poor outcomes. Truncal blocks such as transversus abdominis plane (TAP) blocks have seen limited success due to shorter duration and sub-optimal analgesia. The ultrasound (US)-guided erector spinae plane block (ESPB) w gained wide attention as a fast procedure that carries a lower risk of hypotension, can be used in patients with coagulopathy, is easy to perform, and requires less training. It provides extensive, potent unilateral analgesia, is performed by local anesthetic injection in the plane between the erector spinae muscle and the Transverse process of the corresponding vertebra. The local anesthetic diffuses into the para vertebral space through spaces between adjacent vertebrae and blocks both the dorsal and ventral branches of the thoracic spinal nerves. Bilateral ESPB performed at low thoracic levels was recently shown to provide satisfactory analgesia for gynecologic and abdominal surgery.

Abdominal field blocks, such as the ilio-inguinal / ilio-hypogastric (IL-IH) nerve block are well- known as simple ways to give long-lasting pain relief and limit narcotic usage after surgery.

The ilio-inguinal and ilio-hypogastric nerves are T 12 and L 1 branches that supply the inguinal region and run between the internal oblique and transversus abdominis muscles, slightly above the anterior superior iliac spine.

The aim of this study is to compare the analgesic effect of ilio-hypogastric / ilio-inguinal versus erector spine plane block on female patients undergoing open hysterectomy.

Interventions

  • Other Nerve Block
    Ilioinguinal/ Iliohypogastric nerve block: In the supine position, the ultrasound probe probe is positioned in a transverse manner, superior to the anterior superior iliac spine. The three anterior abdominal muscle layers are identified, and the two nerves are identified in the abdominal neurovascular plane. A echogenicneedle is inserted in a medial-to-lateral direction. After negative aspiration, 5 ml saline is injected to ensure correct needle tip position then 20 ml of bupivacaine 0.25% is

Primary outcome measures

  • The time to first call for analgesia. [Time frame: The first 12 postoperative hours]
Secondary outcome measures (2)
  • postoperative pain score [Time frame: VAS was assessed at 0, 2, 6, and 12 hours postoperatively.]
  • intraoperative hemodynamic changes [Time frame: Operative time]

Eligibility criteria

Inclusion criteria

  • Adult female patients above the age of 35 years.
  • American Society of Anesthesiologists (ASA) physical status I-II.

Exclusion criteria

  • Patient refusal.
  • History of allergy or intolerance to study medications.
  • Chronic opioid use (>3 months).
  • Severe renal or hepatic impairment.
  • Patients with coagulopathy disorders.
  • Infection at injection sites.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07113600 · N-119_2023/MSc

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗