Quadratus Lumborum Block Versus Dual Transversus Abdominis Plane and Ilioinguinal/Iliohypogastric Nerve Blocks for Postoperative Analgesia Following Total Abdominal Hysterectomy

NCT04382274 | Completed DMC

• 1 other identifier: QL versus TAB/II&IH block
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Multimodal pain management program is needed to control severe pain after abdominal hysterectomy which is considered as one of the major abdominal surgeries. Opioids (which are the analgesic of choice) have many adverse effects such as sedation, nausea, and vomiting. Hence, different methods are needed to control pain and decrease opioid consumption and its side effects. Transversus abdominis plane (TAP) block blocks the sensory afferent nerves run between the abdominal muscles and controls postoperative incisional pain. Blanco was the first who described the quadratus lumborum block (QLB). Somatic pain after upper and lower abdominal surgery can be controlled by QLB. QLB can be performed for all generations (adult, pediatrics, and pregnant). QLB is considered to be an easy technique to learn as it is easy to get the key sonoanatomic markers for QLB. The novice can learn this block after only a few performance of the procedure. QLB produces effective postoperative analgesia after abdominal surgery, laparoscopic surgery, anterior abdominal wall surgery, and hip and femur surgery. The analgesic effect of QLB covers 24-48 h. While some authors inserted catheter for continuous infusion of the local anesthetic drug to extend the duration of postoperative analgesia, others added dexamethasone to local anesthetic to extend the effect of local anesthetic drugs. Ultrasound (US)-guided Ilioinguinal and Iliohypogastric nerve and TAP block have been established as analgesic adjuncts for post hernia repair pain management, under general anaesthesia, neuraxial, MAC and infiltration techniques. US-guided technique of blocking Ilioinguinal and Iliohypogastric nerves have higher success rate compared to conventional technique. TAP block provides analgesia to the parietal peritoneum and skin of the abdomen in infra-umbilical surgeries. Few cadaveric studies showed good analgesic effect in the region between T10 and L1 following a single posterior TAP injection.

Conditions

Hysterectomy

Keywords

Hysterectomy; postoperative pain

Outcome Measures

Primary Outcomes (1)

• The total dose of morphine used

  The total dose of morphine used postoperatively/patient (rescue analgesia) within first 24 h postoperative

  up to 24 hours postoperative

Secondary Outcomes (4)

• The total dose of intraoperatively fentanyl

  during the procedure/surgery

• Duration of postoperative analgesia

  up to 24 hours postoperative

• Number of patients needed rescue analgesia

  up to 24 hours postoperative

• Postoperative pain severity

  up to 24 hours postoperative

Study Arms (2)

Quadratus Lumborum Block

EXPERIMENTAL

the transducer will be placed at the level of the anterior superior iliac spine and moved cranially until the three abdominal wall muscles will be clearly identified. The external oblique muscle will be followed posterolaterally until its posterior border will be visualized, leaving underneath the internal oblique muscle, like a roof over the QL muscle. The probe will be tilted down to identify a bright hyperechoic line that represented the middle layer of the thoracolumbar fascia. The needle will be inserted in plane from anterolateral to posteromedial then placed between the thoracolumbar fascia and the QL muscle, and after negative aspiration, the correct position of the needle will be proved by injection of 5 mL of normal saline to confirm the space with a hypoechoic image and hydrodissection. An injection of 20 mL of 0.25% bupivacaine will be applied

Procedure: Quadratus Lumborum Block

Dual block

EXPERIMENTAL

the probe will be located between the iliac crest and the lower costal margin in the anterior axillary line at the level of umbilicus, and the layers of abdominal wall will be identified (external oblique, internal oblique, and transverse abdominis muscles). In-plane technique will be used and the tip of the needle was inserted between the internal oblique and transverse abdominis muscles. After negative aspiration (to exclude intravascular injection), 20 mL of 0.25% bupivacaine will be injected. Then abdomen will be scanned through anterior superior iliac spine (ASIS)-umbilicus line. Ilioinguinal nerve can be visualised between the internal oblique and transverse or external oblique muscles and within 1 to 3 cm from the ASIS. The iliohypogastric nerve lies immediately adjacent. After negative aspiration (to exclude intravascular injection), 10 mL of 0.25% bupivacaine will be injected. The same technique will be performed on the other side.

Procedure: Dual Transversus Abdominis Plane and Ilioinguinal/Iliohypogastric Nerve blocks

Interventions

Quadratus Lumborum Block PROCEDURE

transducer will be placed at the level of the anterior superior iliac spine and moved cranially until the three abdominal wall muscles will be clearly identified. The external oblique muscle will be followed posterolaterally until its posterior border will be visualized leaving underneath the internal oblique muscle, like a roof over the QL muscle. The probe will be tilted down to identify a bright hyperechoic line that represented the middle layer of the thoracolumbar fascia. The needle will be inserted in plane from anterolateral to posteromedial. The needle tip will be placed between the thoracolumbar fascia and the QL muscle, and after negative aspiration, the correct position of the needle will be proved by injection of 5 mL of normal saline to confirm the space with a hypoechoic image and hydrodissection. An injection of 20 mL of 0.25% bupivacaine will be applied

Quadratus Lumborum Block

Dual Transversus Abdominis Plane and Ilioinguinal/Iliohypogastric Nerve blocks PROCEDURE

the probe will be located between the iliac crest and the lower costal margin in the anterior axillary line at the level of umbilicus, and the layers of abdominal wall will be identified (external oblique, internal oblique, and transverse abdominis muscles). In-plane technique will be used and the tip of the needle was inserted between the internal oblique and transverse abdominis muscles. After negative aspiration (to exclude intravascular injection), 20 mL of 0.25% bupivacaine will be injected. Then abdomen will be scanned through anterior superior iliac spine (ASIS)-umbilicus line. Ilioinguinal nerve can be visualised between the internal oblique and transverse or external oblique muscles and within 1 to 3 cm from the ASIS. The iliohypogastric nerve lies immediately adjacent. After negative aspiration (to exclude intravascular injection), 10 mL of 0.25% bupivacaine will be injected. The same technique will be performed on the other side.

Dual block

Eligibility Criteria

• Age: 45 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• female patients 2. aged 45-60 years 3. ASA Physical Status Class I and II 4. scheduled for abdominal hysterectomy

You may not qualify if:

• Patients had infection at injection site
• Allergy to local anesthetics
• Coagulation disorders
• Severe obesity
• Physical or mental diseases which could interfere with the evaluation of pain scores
• Kidney failure or liver failure.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Amany Afheem

Tanta, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 11, 2020
• Study Start: May 2, 2020
• Primary Completion: October 31, 2020
• Study Completion: November 1, 2020
• Last Updated: November 30, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)