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Completed

NCT Number: NCT04835415

Ultrasound Guided : Retrolaminar Block Versus Thoracic Epidural Analgesia Following Laparoscopic Cholecystectomy

The aim of this study is to evaluate analgesic effect of ultrasound-guided retrolaminar block vs ultrasound-guided thoracic epidural analgesia in pain control following laparoscopic cholecystectomy.

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Key information

Conditions

Analgesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

21 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of medicine, Zagazig university

Zagazig, Egypt

About this study

To study the difference between the effects of ultrasound-guided bilateral retrolaminar block and ultrasound-guided thoracic epidural analgesia on pain control following laparoscopic cholecystectomy. To relief pain and improve satisfaction in patients undergoing laparoscopic cholecystectomy at Zagazig university hospitals.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Written informed consent from the patient.
  • Age: 21-45 years old.
  • Sex: both sex (males and females).
  • Physical status: ASA 1& II.
  • BMI = (25-35 kg/m2).
  • Type of operation: elective laparoscopic cholecystectomy

Exclusion criteria

  • Altered mental state.
  • Patients with known history of allergy to study drugs.
  • Advanced hepatic, renal, cardiovascular, and respiratory diseases.
  • Patients with chronic pain.
  • Patients receiving anticoagulants.
  • Contraindications of regional anesthesia, e.g., allergy to local anesthetics, coagulopathy, or septic focus at site of injection.

Treatment and study plan

Bilateral retrolaminar block

Procedure

in lateral position and after skin sterilization. The spine is palpated from cervical (C7) downward toT7 and point marked to identify the spinous process. The linear high frequency transducer (6-13 MHz) will be placed parasagittal plane 1 cm lateral to the midline. The needle (18 gauge) is inserted in the plane view of the ultrasound probe to target the T7 and needle is advanced from downward to upward until the needle tip contacted the lamina. After negative aspiration, a 20 ml of bupivacaine 0.25 % plus 5ug/ml adrenaline (1:200000) will be injected. The procedure will be repeated following the same steps on the other side.

Other names: Ultrasound guided retrolaminar block

Thoracic epidural analgesia

Procedure

In the lateral position, after skin sterilization, Ultrasound with high frequency linear probe (5-13 MHz). Thoracic intervertebral space (T7-8) will be identified by counting from the C7 to prominent thoracic spine (T7). The probe will be used in parasagittal plane 2 cm from midline. The probe will be directed medially to identify the dura matter at the T7-8 intervertebral space . the needle 18 gauage will be inserted in plane to target T7-8 intervertebral space ., after needle tip reached target space, loss of resistance technique then 20 ml bupivacaine 0.25% plus 5ug/ml adrenaline (1:200000) was injected after aspiration

Other names: Ultrasound guided thoracic epidural

Primary outcomes

  1. Pain intensity at rest and at cough using Numerical Rating Scales (NRS)

    Time frame: 30 minutes postoperative

    measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)

  2. Pain intensity at rest and at cough using Numerical Rating Scales (NRS)

    Time frame: at 1 hour postoperative

    measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)

  3. Pain intensity at rest and at cough using Numerical Rating Scales (NRS)

    Time frame: at 2 hours postoperative

    measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)

  4. Pain intensity at rest and at cough using Numerical Rating Scales (NRS)

    Time frame: at 4 hours postoperative

    measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)

  5. Pain intensity at rest and at cough using Numerical Rating Scales (NRS)

    Time frame: at 6 hours postoperative

    measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)

  6. Pain intensity at rest and at cough using Numerical Rating Scales (NRS)

    Time frame: at 8 hours postoperative

    measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)

  7. Pain intensity at rest and at cough using Numerical Rating Scales (NRS)

    Time frame: at 10 hours postoperative

    measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)

  8. Pain intensity at rest and at cough using Numerical Rating Scales (NRS)

    Time frame: at 12 hours postoperative

    measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)

Secondary outcomes

  1. Time to first call of rescue analgesia

    Time frame: within 12 hours postoperative

    start from retrolaminar or epidural injection of the drug to the time of first call of naluphine

  2. Total analgesic (Naluphine) consumption

    Time frame: within 12 hours postoperative

    Total consumption of rescue analgesia(Naluphine) post operative

  3. The number of participant with complications of the techinque (dural puncture , nerve injury, spinal injection, epidural haematoma, pleural puncture)

    Time frame: within 24 hours postoperative

    The numer of participant with complications of the techinque (dural puncture , nerve injury, spinal injection, epidural haematoma, pleural puncture)

  4. Patient satisfaction is recorded at the end of 24 hours postoperative

    Time frame: 24 hours postoperative

    using 5-point Likert-like verbal rating scale by asking the patient about "how he/she evaluated their experience with the analgesic management after the surgery?"5=very satisfied, 4=satisfied, 3= neutral, 2= dissatisfied and 1= very dissatisfied".

  5. The number of participant with nausea, vomiting, hypotension and bradycardia.

    Time frame: 24 hours postoperative

    the number of participant with nausea (sensation of being about to vomit), vomiting (the expelling of the food content from the stomach through mouth, it will be treated by 4 mg ondansetron), hypotension (if MAP decreases more than 20% of basal reading it will be treated by 12 mg ephedrine) and bradycardia (if HR less than 50 beats/min it will be treated by 0.5 mg atropine).

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

Ultrasound Guided : Retrolaminar Block Versus Thoracic Epidural Analgesia for Pain Control Following Laparoscopic Cholecystectomy

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 8, 2021
Registry last updated
Jan 27, 2022

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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