Back to resultsUltrasound Guided : Retrolaminar Block Versus Thoracic Epidural Analgesia Following Laparoscopic Cholecystectomy
Primary Purpose
Analgesia
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Bilateral retrolaminar block
Thoracic epidural analgesia
Sponsored by
About this trial
This is an interventional treatment trial for Analgesia focused on measuring Ultrasound, Bilateral retrolaminar, Thoracic epidural, post operative analgesia, Laparoscopic cholecystectomy
Eligibility Criteria
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.
Sites / Locations
- faculty of medicine, Zagazig university
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
group T
group R
Arm Description
Group (T) (n=26): will receive ultrasound guided thoracic epidural analgesia: 20 ml of bupivacaine 0.25 % plus 5ug/ml adrenaline (1:200000).
Group (R) (n=26): will receive bilateral ultrasound guided retrolaminar block analgesia: 20 ml of bupivacaine 0.25 % plus 5ug/ml adrenaline (1:200000).
Outcomes
Primary Outcome Measures
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)
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)
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)
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)
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)
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)
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)
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)
Secondary Outcome Measures
Time to first call of rescue analgesia
start from retrolaminar or epidural injection of the drug to the time of first call of naluphine
Total analgesic (Naluphine) consumption
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)
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
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.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04835415
Brief Title
Ultrasound Guided : Retrolaminar Block Versus Thoracic Epidural Analgesia Following Laparoscopic Cholecystectomy
Official Title
Ultrasound Guided : Retrolaminar Block Versus Thoracic Epidural Analgesia for Pain Control Following Laparoscopic Cholecystectomy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
April 10, 2021 (Actual)
Primary Completion Date
November 15, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia
Keywords
Ultrasound, Bilateral retrolaminar, Thoracic epidural, post operative analgesia, Laparoscopic cholecystectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Analgesia for postoperative pain after laparoscopic cholecystectomy by using ultrasound-guided retrolaminar block vs ultrasound-guided thoracic epidural analgesia.
Masking
ParticipantOutcomes Assessor
Masking Description
Double (participant, outcomes assessor) Anesthetist not sharing in the study will assess patient.
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
group T
Arm Type
Active Comparator
Arm Description
Group (T) (n=26): will receive ultrasound guided thoracic epidural analgesia: 20 ml of bupivacaine 0.25 % plus 5ug/ml adrenaline (1:200000).
Arm Title
group R
Arm Type
Active Comparator
Arm Description
Group (R) (n=26): will receive bilateral ultrasound guided retrolaminar block analgesia: 20 ml of bupivacaine 0.25 % plus 5ug/ml adrenaline (1:200000).
Intervention Type
Procedure
Intervention Name(s)
Bilateral retrolaminar block
Other Intervention Name(s)
Ultrasound guided retrolaminar block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Thoracic epidural analgesia
Other Intervention Name(s)
Ultrasound guided thoracic epidural
Intervention Description
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
Primary Outcome Measure Information:
Title
Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
Description
measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)
Time Frame
30 minutes postoperative
Title
Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
Description
measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)
Time Frame
at 1 hour postoperative
Title
Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
Description
measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)
Time Frame
at 2 hours postoperative
Title
Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
Description
measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)
Time Frame
at 4 hours postoperative
Title
Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
Description
measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)
Time Frame
at 6 hours postoperative
Title
Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
Description
measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)
Time Frame
at 8 hours postoperative
Title
Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
Description
measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)
Time Frame
at 10 hours postoperative
Title
Pain intensity at rest and at cough using Numerical Rating Scales (NRS)
Description
measured by NRS consisted of a series of numbers represents range of pain intensity (10 means the worst pain and 0 means no pain)
Time Frame
at 12 hours postoperative
Secondary Outcome Measure Information:
Title
Time to first call of rescue analgesia
Description
start from retrolaminar or epidural injection of the drug to the time of first call of naluphine
Time Frame
within 12 hours postoperative
Title
Total analgesic (Naluphine) consumption
Description
Total consumption of rescue analgesia(Naluphine) post operative
Time Frame
within 12 hours postoperative
Title
The number of participant with complications of the techinque (dural puncture , nerve injury, spinal injection, epidural haematoma, pleural puncture)
Description
The numer of participant with complications of the techinque (dural puncture , nerve injury, spinal injection, epidural haematoma, pleural puncture)
Time Frame
within 24 hours postoperative
Title
Patient satisfaction is recorded at the end of 24 hours postoperative
Description
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".
Time Frame
24 hours postoperative
Title
The number of participant with nausea, vomiting, hypotension and bradycardia.
Description
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).
Time Frame
24 hours postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dina Salem, MD.
Organizational Affiliation
faculty of medicine , Zagazig University
Official's Role
Principal Investigator
Facility Information:
Facility Name
faculty of medicine, Zagazig university
City
Zagazig
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ultrasound Guided : Retrolaminar Block Versus Thoracic Epidural Analgesia Following Laparoscopic Cholecystectomy
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