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Completed

NCT Number: NCT04635644

Ultrasound Guided ESP Block Versus Intrathecal Morphine for Postoperative Analgesia in Major HPB Surgery.

To compare the efficacy of USG-guided bilateral Erector spinae plane block (ESPB) with intrathecal morphine (ITM) for postoperative analgesia after major hepatopancreaticobiliary surgery (HPB)

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assiut University hospital

Asyut, Asyut Governorate, 11111, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 65 years with a body mass index (BMI) of 18-35 kg/m2,
  • patients with the American Society of Anesthesiologists (ASA) physical status I - II,
  • Patients scheduled for elective major hepatopancreaticobiliary surgery for benign or malignant disease; major surgery is defined as an operation of anticipated duration of more than one hour.

Exclusion criteria

  • Patient's refusal
  • Allergy or contraindications to the study drugs,
  • Infection at the site of injection,
  • Coagulopathy,
  • Psychiatric disorders
  • Severely co-morbid patients,
  • Chronic pain syndromes,
  • Prolonged opioid medication,

Treatment and study plan

Erector Spinae Plane Block

Procedure

Patients will be turned into the prone position. A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T8 spinous process. The erector spinae muscles will be identified superficial to the tip of the T8 transverse process. After local infiltration of the needle insertion site with 2-3 ml of 2% lidocaine, a 21G 10 cm needle will be inserted using an in-plane approach in a cranial to caudal direction to contact the T8 transverse process. The location of the needle tip will be confirmed by hydrodissection with 2 mL of lidocaine 2% and visualizing linear fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging. A volume of 20 mL of 0.25% Bupivacaine is injected will be injected at this point. The same procedure will be repeated for the opposite side.

Other names: ESP block

Intrathecal Morphine

Procedure

Patients will be placed on their right side. An intrathecal injection of morphine 200 μg (0.2 mL of morphine sulfate 1 mg/mL) diluted in 1.8 mL normal saline will be administered at the L3-L4 or L4-L5 level with a 25 G Whitacre spinal needle.

Other names: ITM

Primary outcomes

  1. Cumulative opioid consumption

    Time frame: 24 hours postoperatively

    Nalbuphine consumption in mg equivalent to morphine dose

Secondary outcomes

  1. Nalbuphine consumption in mg

    Time frame: at 8, 48, and 72 hours postoperatively.

    equivalent to morphine dose

  2. Analgesic drug consumption other than nalbuphine

    Time frame: at 8, 24, 48, and 72 hours postoperatively.

    consumption in mg

  3. Numerical Rating Scale (NRS) at rest and when coughing

    Time frame: at 1, 2, 4, 8, 12, 24, 48 and 72 hours postoperatively

    NRS is an 11-point (0=no pain and 10=worst pain)

  4. Heart Rate

    Time frame: Intraoperatively

    Heart Rate in beats /min

  5. Mean Arterial Pressure

    Time frame: Intraoperatively

    Mean Arterial Pressure in mmHg

  6. Incidence of Postoperative nausea & vomiting (PONV)

    Time frame: 24 hours postoperatively

    Number of patients developing PONV

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Ultrasound Guided Erector Spinae Block Versus Intrathecal Morphine for Postoperative Analgesia in Major Hepatopancreaticobiliary Surgery

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Nov 19, 2020
Registry last updated
May 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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