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NCT Number: NCT04167176

Comparison of Analgesic Efficacy of US Guided ESP Block With Port Site Infiltration Following Laparoscopic Cholecystectomy

To compare the efficacy of ultrasonography (USG)-guided bilateral Erector spinae plane block (ESPB) with port-site infiltration using bupivacaine for post-operative analgesia after laparoscopic cholecystectomy with a hypothesis that both Erector spinae plane block and port-site infiltration are effective in providing post-operative analgesia.

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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–60 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

  • patients with the American Society of Anesthesiologists (ASA) physical status I/II,
  • Age between 18 and 60 years with a body mass index (BMI) of 18-35 kg/m2,
  • Patients scheduled for elective laparoscopic cholecystectomy.

Exclusion criteria

  • Allergy to local anaesthetics,
  • Infection at the site of injection,

•, Coagulopathy,

  • Chronic pain syndromes,
  • Prolonged opioid medication,
  • Patients who received any analgesic 24 h before surgery

Treatment and study plan

Erector Spinae Plane Block

Procedure

Patients will be placed on their right side. A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. A 21G 10-cm needle will be inserted using an in-plane approach in a cranial to caudal direction. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging. A volume of 20 mL of LA mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine 2% and 5 mL of normal saline to make a mixture totaling 20 ml.) will be injected. The same procedure will be repeated for the opposite side.

Other names: ESP block

Port site infiltration

Procedure

After the induction of anaesthesia, pre-incisional port-site infiltration will be performed by the same surgeon every time with 20 ml of the LA mixture. The volume will be divided equally between port sites. A total of four ports-supraumbilical, subxiphoid and two ports in the right subcostal area at mid-clavicular and anterior axillary line will be made.

Ultrasound machine (Mindray DP 9900 plus; Mindray Bio-Medical Electronics, Shenzhen, China)

Device

Ultrasound will be used to identify the erector spinae muscles and to guide the LA mixture injection.

Bupivacaine 0.5%

Drug

Bupivacaine 0.5% will be included in the injected LA mixture.

Lidocaine 2%

Drug

Lidocaine 2% will be included in the injected LA mixture.

Primary outcomes

  1. Total postoperative opioid consumption.

    Time frame: 24 hours postoperatively

    Nalbuphine consumption in mg.(equivalent to morphine dose)

Secondary outcomes

  1. Pain scores;Numerical Rating Scale (NRS) at rest and when coughing

    Time frame: at 1, 2,4 , 8, 16 and 24 hours postoperatively.

    The NRS is a segmented numeric version of the Visual Analog Scale (VAS) in which a respondent selects a whole number (0-10 integers).

  2. •Cumulative postoperative analgesic consumption

    Time frame: 24 hours postoperatively

    Analgesic drug consumption other than nalbuphine in mg.

  3. •Heart Rate (HR)

    Time frame: Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery

    Heart Rate in beats /min

  4. •Mean Arterial Pressure (MAP)

    Time frame: Intraoperatively at 0, 5,10, 20, and 30 minutes. Then every 15 min thereafter till the end of surgery

    Mean Arterial Pressure in mmHg

  5. Incidence and severity Postoperative nausea & vomiting (PONV).

    Time frame: 24 hours postoperatively

    Number of patients developing PONV & PONV Score; (1) No nausea or vomiting, (2) only nausea but no vomiting, (3) single episode of vomiting or persistent nausea, and (4) two or more episodes of vomiting or severe retching.

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Comparison of Analgesic Efficacy of Ultrasound Guided Erector Spinae Plane Block With Port Site Infiltration Following Laparoscopic Cholecystectomy

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Nov 18, 2019
Registry last updated
Dec 20, 2022

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

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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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