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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Analgesia

Intervention / Treatment
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* Procedure: Bilateral retrolaminar block
* Procedure: Thoracic epidural analgesia


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Analgesia for postoperative pain after laparoscopic cholecystectomy by using ultrasound-guided retrolaminar block vs ultrasound-guided thoracic epidural analgesia.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group T<br>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<br>* 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<br>* Other names: Ultrasound guided thoracic epidural;|
| Active Comparator: group R<br>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<br>* 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.<br>* Other names: Ultrasound guided retrolaminar block;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasound, Bilateral retrolaminar, Thoracic epidural, post operative analgesia, Laparoscopic cholecystectomy