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

Sponsor

Zagazig University (Other)

Overall Status

Completed

CT.gov ID

NCT04835415

Collaborator

(none)

Enrollment

Location

Arms

7.7

Actual Duration (Months)

6.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Analgesia	Procedure: Bilateral retrolaminar block Procedure: Thoracic epidural analgesia	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

Double (participant, outcomes assessor) Anesthetist not sharing in the study will assess patient.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 10, 2021

Actual Primary Completion Date :

Nov 15, 2021

Actual Study Completion Date :

Dec 1, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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)
Pain intensity at rest and at cough using Numerical Rating Scales (NRS) [at 1 hour 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)
Pain intensity at rest and at cough using Numerical Rating Scales (NRS) [at 2 hours 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)
Pain intensity at rest and at cough using Numerical Rating Scales (NRS) [at 4 hours 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)
Pain intensity at rest and at cough using Numerical Rating Scales (NRS) [at 6 hours 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)
Pain intensity at rest and at cough using Numerical Rating Scales (NRS) [at 8 hours 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)
Pain intensity at rest and at cough using Numerical Rating Scales (NRS) [at 10 hours 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)
Pain intensity at rest and at cough using Numerical Rating Scales (NRS) [at 12 hours 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 Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 45 Years

Sexes Eligible for Study:

All

Accepts 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.