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

• ClinicalTrials.gov Identifier: NCT04835415
• Recruitment Status: Completed
• First Posted: April 8, 2021
• Last Update Posted: January 27, 2022
• Sponsor: Zagazig University
• Information provided by (Responsible Party): Dina Abdelhameed Elsadek Salem, Zagazig University

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	Not Applicable

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 (Clinical Trial)
• 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.
• 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: April 10, 2021
• Actual Primary Completion Date: November 15, 2021
• Actual Study Completion Date: December 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 Name: 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 Name: Ultrasound guided retrolaminar block

Outcome Measures

Primary Outcome Measures :

1. Pain intensity at rest and at cough using Numerical Rating Scales (NRS) [ Time Frame: 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)
2. Pain intensity at rest and at cough using Numerical Rating Scales (NRS) [ Time Frame: 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)
3. Pain intensity at rest and at cough using Numerical Rating Scales (NRS) [ Time Frame: 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)
4. Pain intensity at rest and at cough using Numerical Rating Scales (NRS) [ Time Frame: 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)
5. Pain intensity at rest and at cough using Numerical Rating Scales (NRS) [ Time Frame: 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)
6. Pain intensity at rest and at cough using Numerical Rating Scales (NRS) [ Time Frame: 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)
7. Pain intensity at rest and at cough using Numerical Rating Scales (NRS) [ Time Frame: 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)
8. Pain intensity at rest and at cough using Numerical Rating Scales (NRS) [ Time Frame: 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 :

1. Time to first call of rescue analgesia [ Time Frame: within 12 hours postoperative ]
   start from retrolaminar or epidural injection of the drug to the time of first call of naluphine
2. Total analgesic (Naluphine) consumption [ Time Frame: within 12 hours postoperative ]
   Total consumption of rescue analgesia(Naluphine) post operative
3. The number of participant with complications of the techinque (dural puncture , nerve injury, spinal injection, epidural haematoma, pleural puncture) [ Time Frame: within 24 hours postoperative ]
   The numer of participant with complications of the techinque (dural puncture , nerve injury, spinal injection, epidural haematoma, pleural puncture)
4. Patient satisfaction is recorded at the end of 24 hours postoperative [ Time Frame: 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".
5. The number of participant with nausea, vomiting, hypotension and bradycardia. [ Time Frame: 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

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

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.

Contacts and Locations

Locations

Egypt

faculty of medicine, Zagazig university

Zagazig, Egypt

Sponsors and Collaborators

Zagazig University

Investigators

• Principal Investigator: Dina Salem, MD.; faculty of medicine , Zagazig University

More Information

• Responsible Party: Dina Abdelhameed Elsadek Salem, Principle investigator, Zagazig University
• ClinicalTrials.gov Identifier: NCT04835415
• Other Study ID Numbers: 6777
• First Posted: April 8, 2021
• Last Update Posted: January 27, 2022
• Last Verified: January 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dina Abdelhameed Elsadek Salem, Zagazig University:

Ultrasound; Bilateral retrolaminar; Thoracic epidural; post operative analgesia; Laparoscopic cholecystectomy

Additional relevant MeSH terms:

Agnosia; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases