Comparison of US Bilateral Erector Spinae Plane Block, US Bilateral Quadratus Lumborum Block and Lumbar Epidural for Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy

NCT06397300 | Completed DMC

• 2 other identifiers: AP2312-201-095IRB00004025
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

The investigators hypothesize that US Bilateral Erector Spinae Plane Block, US Bilateral Quadratus Lumborum Block and Lumbar Epidural for Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy resulting in reducing myofascial pain and opioid consumption.

Conditions

Comparison of US Bilateral Erector Spinae Plane Block, US Bilateral Quadratus Lumborum Block and Lumbar Epidural

Keywords

Analgesics; Opioids; Postoperative Pain; Nerve block; ultrasound; Hysterectomy; cancer; ovarian neoplasm; uterine carcinoma

Outcome Measures

Primary Outcomes (1)

• Total postoperative opioid consumption

  Total postoperative morphine consumption till the first 24 hours postoperatively

  first 24 hours postoperatively

Secondary Outcomes (5)

• Ramsay scores

  at 0, 4, 8, 12, and 24 postoperatively.

• Visual analogue scale VAS

  0, 4, 8, 12 and 24 postoperatively.

• Total intraoperative fentanyl consumption

  intraoperative

• mean arterial blood pressure.

  intraoperative and 0, 4, 8, 12 and 24 postoperatively.

• Postoperative nausea and vomiting

  24 hours Postoperative

Study Arms (3)

bilateral Ultrasound guided erector spinae plane (ESP) block

ACTIVE COMPARATOR

. To perform ESP block in the lateral position bilaterally, a linear transducer is placed in a longitudinal parasagittal orientation and erector spinae muscle, trapezius muscle, rhomboid major muscle and transverse process are visualized and local anesthetic is injected (0.25% bupivacaine 20 ml in each side) in the area between transverse process and erector spinae muscle at T10 level.

Procedure: bilateral Ultrasound guided erector spinae plane (ESP) block

quadratus lumborum block

ACTIVE COMPARATOR

In the lateral decubitus position. Right block will be performed; the patient will then repositioned for the left block. An ultrasound device with a convex probe (5-8 MHz) will be placed in the mid-axillary line just above the iliac crest. Then, scan dorsally to keep the transverse orientation until seeing the aponeurosis of the transverses abdominus muscle and by following this aponeurosis, QL muscle will be visualized with its attachment to the lateral edge of the transverse process of the L2 vertebral body and visualize the thoracolumbar fascia at the lateral edge of the QL muscle. A spinal needle (20G) will be inserted in-plane from the anterior to posterior direction, and the tip of the needle will be advanced anterior to the QL muscle. The target site for injection is the plane between the quadratus lumborum and psoas major muscles. This will be followed by injection of 0.25% bupivacaine 20 ml in each side.

Procedure: quadratus lumborum block

lumbar epidural

ACTIVE COMPARATOR

under strict aseptic precautions, lumbar epidural was performed for patients in Group III using a 16-gauge Touhy epidural needle by a median approach. The T12 - L1 or L1 - L2 interspaces was chosen for the injection. The epidural space identified by the loss of resistance technique. The catheter was advanced 4 cm cephalad. When the aspiration test results for blood and cerebrospinal fluid were negative, a test dose of (3 mL) 2% lidocaine with 1: 200,000 adrenaline was given after the placement of the epidural catheter. Then this will be followed by injection of 0.25% bupivacaine 15 ml as a single injection after induction of general anesthesia.

Procedure: lumbar epidural

Interventions

bilateral Ultrasound guided erector spinae plane (ESP) block PROCEDURE

To perform ESP block in the lateral position bilaterally ,the skin will be disinfected with 70% alchol bilaterally and a linear transducer is placed in a longitudinal parasagittal orientation and erector spinae muscle, trapezius muscle, rhomboid major muscle (rhomboid major muscle is absent below T6 level) and transverse process are visualized and local anesthetic is injected (0.25% bupivacaine 20 ml in each side) in the area between transverse process and erector spinae muscle at T10 level.

bilateral Ultrasound guided erector spinae plane (ESP) block

quadratus lumborum block PROCEDURE

In the lateral decubitus position. Right block will be performed; the patient will then repositioned for the left block. An ultrasound device with a convex probe (5-8 MHz) will be placed in the mid-axillary line just above the iliac crest. Then, scan dorsally to keep the transverse orientation until seeing the aponeurosis of the transverses abdominus muscle and by following this aponeurosis, QL muscle will be visualized with its attachment to the lateral edge of the transverse process of the L2 vertebral body and visualize the thoracolumbar fascia at the lateral edge of the QL muscle. A spinal needle (20G) will be inserted in-plane from the anterior to posterior direction, and the tip of the needle will be advanced anterior to the QL muscle. The target site for injection is the plane between the quadratus lumborum and psoas major muscles. This will be followed by injection of 0.25% bupivacaine 20 ml in each side.

quadratus lumborum block

lumbar epidural PROCEDURE

under strict aseptic precautions, lumbar epidural was performed for patients in Group III using a 16-gauge Touhy epidural needle by a median approach. The T12 - L1 or L1 - L2 interspaces was chosen for the injection. The epidural space identified by the loss of resistance technique. The catheter was advanced 4 cm cephalad. When the aspiration test results for blood and cerebrospinal fluid were negative, a test dose of (3 mL) 2% lidocaine with 1: 200,000 adrenaline was given after the placement of the epidural catheter. Then this will be followed by injection of 0.25% bupivacaine 15 ml as a single injection after induction of general anesthesia.

lumbar epidural

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA class II , III and IV
• yrs ≥ Age ≤ 65yrs
• Body mass index (BMI): 20-40 kg/m2
• Patient undergoing total abdominal hysterectomy under general anesthesia.

You may not qualify if:

• Age \< 18yrs or \> 65yrs
• Patient refusal
• known sensitivity or contraindication to drugs used in the study
• Contraindication to regional anesthesia e.g. local sepsis or coagulopathy
• History of psychological disorders and chronic pain

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

National cancer Insititute

Cairo, 11796, Egypt

Location

Ahmed Mohamed Soliman

Giza, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative; Neoplasms; Ovarian Neoplasms

Interventions

Parapsychology; Dental Occlusion

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Endocrine Gland Neoplasms; Neoplasms by Site; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Behavioral Sciences; Behavioral Disciplines and Activities; Dentistry; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The patients will be randomly assigned into two equal comparable groups using computer- generated random numbers in opaque closed envelopes, each of which will include 30 patients. Randomization will be done by statistician and each group of the patient will revealed only when the included patient is transferred to preanesthetic room.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer of anesthesia

Model Details: To determine the analgesic effect of US Bilateral Erector Spinae Plane Block, US Bilateral Quadratus Lumborum Block and Lumbar Epidural for Postoperative Analgesia in Patients Undergoing Total Abdominal Hysterectomy regarding the following: 1. Post-operative opioid (morphine) consumption in the 1st 24 hours 2. Postoperative Numeric Pain Rating Scale. 3. Effect on hemodynamics: Mean arterial blood pressure and Heart rate. 4. Intraoperative fentanyl consumption. 5. Duration of analgesic effect

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: May 2, 2024
• Study Start: September 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: May 2, 2024

Record last verified: 2024-04

Locations

EG (2)