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

NCT04835415 | Completed

• 1 other identifier: 6777
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Analgesia

Keywords

Ultrasound; Bilateral retrolaminar; Thoracic epidural; post operative analgesia; Laparoscopic cholecystectomy

Outcome Measures

Primary Outcomes (8)

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

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

  30 minutes postoperative

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

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

  at 1 hour postoperative

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

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

  at 2 hours postoperative

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

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

  at 4 hours postoperative

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

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

  at 6 hours postoperative

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

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

  at 8 hours postoperative

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

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

  at 10 hours postoperative

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

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

  at 12 hours postoperative

Secondary Outcomes (5)

• Time to first call of rescue analgesia

  within 12 hours postoperative

• Total analgesic (Naluphine) consumption

  within 12 hours postoperative

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

  within 24 hours postoperative

• Patient satisfaction is recorded at the end of 24 hours postoperative

  24 hours postoperative

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

  24 hours postoperative

Study Arms (2)

group T

ACTIVE COMPARATOR

Group (T) (n=26): will receive ultrasound guided thoracic epidural analgesia: 20 ml of bupivacaine 0.25 % plus 5ug/ml adrenaline (1:200000).

Procedure: Thoracic epidural analgesia

group R

ACTIVE COMPARATOR

Group (R) (n=26): will receive bilateral ultrasound guided retrolaminar block analgesia: 20 ml of bupivacaine 0.25 % plus 5ug/ml adrenaline (1:200000).

Procedure: Bilateral retrolaminar block

Interventions

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.

Also known as: Ultrasound guided retrolaminar block

group R

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

Also known as: Ultrasound guided thoracic epidural

group T

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

faculty of medicine, Zagazig university

Zagazig, Egypt

Location

MeSH Terms

Conditions

Agnosia

Interventions

Tea

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Dina Salem, MD.

  faculty of medicine , Zagazig University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double (participant, outcomes assessor) Anesthetist not sharing in the study will assess patient.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: Analgesia for postoperative pain after laparoscopic cholecystectomy by using ultrasound-guided retrolaminar block vs ultrasound-guided thoracic epidural analgesia.

Study Record Dates

• First Submitted: April 4, 2021
• First Posted: April 8, 2021
• Study Start: April 10, 2021
• Primary Completion: November 15, 2021
• Study Completion: December 1, 2021
• Last Updated: January 27, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)