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

Ultrasound Guided : Retrolaminar Block Versus Thoracic Epidural Analgesia for Pain Control 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.

Study Overview

• Status: Completed
• Conditions: Analgesia
• Intervention / Treatment: Procedure: Thoracic epidural analgesia; Procedure: Bilateral retrolaminar block

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Zagazig, Egypt
    • Faculty of medicine, Zagazig university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group T; 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; 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
Active Comparator: group R; 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; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first call of rescue analgesia	start from retrolaminar or epidural injection of the drug to the time of first call of naluphine	within 12 hours postoperative
Total analgesic (Naluphine) consumption	Total consumption of rescue analgesia(Naluphine) post operative	within 12 hours postoperative
The number of participant with complications of the techinque (dural puncture , nerve injury, spinal injection, epidural haematoma, pleural puncture)	The numer 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	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".	24 hours postoperative
The number of participant with nausea, vomiting, hypotension and bradycardia.	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).	24 hours postoperative

Collaborators and Investigators

• Sponsor: Zagazig University
• Investigators: Principal Investigator: Dina Salem, MD., Faculty of Medicine , Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2021
• Primary Completion (Actual): November 15, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: April 4, 2021
• First Submitted That Met QC Criteria: April 6, 2021
• First Posted (Actual): April 8, 2021

Study Record Updates

• Last Update Posted (Actual): January 27, 2022
• Last Update Submitted That Met QC Criteria: January 11, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Ultrasound; Laparoscopic cholecystectomy; post operative analgesia; Thoracic epidural; Bilateral retrolaminar
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia
• Other Study ID Numbers: 6777

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No