Analgesia
Conditions
Keywords
Ultrasound, Bilateral retrolaminar, Thoracic epidural, post operative analgesia, Laparoscopic cholecystectomy
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.
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.
Interventions
PROCEDUREBilateral 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.
PROCEDUREThoracic 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
Sponsors
Zagazig University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Double (participant, outcomes assessor) Anesthetist not sharing in the study will assess patient.
Intervention model description
Analgesia for postoperative pain after laparoscopic cholecystectomy by using ultrasound-guided retrolaminar block vs ultrasound-guided thoracic epidural analgesia.
Eligibility
Sex/Gender
ALL
Age
21 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity at rest and at cough using Numerical Rating Scales (NRS) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to first call of rescue analgesia | within 12 hours postoperative | start from retrolaminar or epidural injection of the drug to the time of first call of naluphine |
| Total analgesic (Naluphine) consumption | within 12 hours postoperative | Total consumption of rescue analgesia(Naluphine) post operative |
| The number of participant with complications of the techinque (dural puncture , nerve injury, spinal injection, epidural haematoma, pleural puncture) | within 24 hours postoperative | The numer of participant with complications of the techinque (dural puncture , nerve injury, spinal injection, epidural haematoma, pleural puncture) |
| Patient satisfaction is recorded at the end of 24 hours postoperative | 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. |
| The number of participant with nausea, vomiting, hypotension and bradycardia. | 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). |
Countries
Egypt
Outcome results
None listed