Comparison Between Dexmedetomidine and Fentanyl As an Adjuvant to Bupivacaine in the Paravertebral Nerve Block in Laparoscopic Cholecystectomy for Postoperative Analgesia: Randomized Comparative Clinical Trial.

NCT06752629 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: dexm VS fenta cholecystectomy
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Laparoscopic cholecystectomy is one of the most common surgeries today, cause it has many advantages over open cholecystectomy. Although these advantages pain remains a big problem after laparoscopic cholecystectomy which causes patient admission or readmission. This post-operative laparoscopic cholecystectomy pain causes extreme patient discomfort, extended post-anesthesia care unit stay and restricts early recovery. To overcome this problem, there were trials of inta abdominal instillation with local anesthetics with no positive results , so they combined this with local infiltration at the laparoscopic access sites with no satisfactory postoperative analgesia. The aim of this study is to evaluate the effect and the difference between dexmedetomidine and fentanyl in pre-operative unilateral (T5\&6) thoracic paravertebral block for postoperative analgesia in laparoscopic cholecystectomy

Conditions

Laparoscopic Cholecystectomy

Keywords

paravertebral nerve block

Outcome Measures

Primary Outcomes (1)

• level of sensory block duration

  We will evaluate the sensory block by counting the number of dermatomes at regular intervals . Dermatome regression will be used as a marker of sensory block.

  48 hours

Study Arms (2)

group 1

EXPERIMENTAL

Adult patients will take 10 ml Bupivacaine 0.5% plus 2ml solution of Dexmedetomidine 1mic/kg in the bilateral T5\&6 preoperatively

Drug: Bupivacaine and Dexmedetomidine

group 2

EXPERIMENTAL

Adult patients will take 10 ml Bupivacaine 0.5% plus 2ml solution of Fentanyl 20 microgram with the bilateral T5\&6 preoperatively.

Drug: Bupivacaine and Fentanyl

Interventions

Bupivacaine and Dexmedetomidine DRUG

Adult patients will take 10 ml Bupivacaine 0.5% plus 2ml solution of Dexmedetomidine 1mic/kg in the bilateral T5\&6 preoperatively

group 1

Bupivacaine and Fentanyl DRUG

Adult patients will take 10 ml Bupivacaine 0.5% plus 2ml solution of Fentanyl 20 microgram with the bilateral T5\&6 preoperatively

group 2

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients within age; (18-60)
• Body mass index (BMI); (18-30)
• ASA I - II

You may not qualify if:

• ● Patient refusal to participate in the study
• Allergy to local anesthetics
• Coagulopathy
• Morbid obesity
• Decreased pulmonary reserve
• Cardiac disorder
• Renal dysfunction
• Pre-existing neurological deficit
• Psychiatric illness

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Bupivacaine; Dexmedetomidine; Fentanyl

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines

Central Study Contacts

Eithar Mahmoud Abd-Elsalm, resident doctor

CONTACT

+201220805991; ethar.16266036@med.aun.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: resident doctor at Assiut University hospital

Study Record Dates

• First Submitted: December 11, 2024
• First Posted: December 31, 2024
• Study Start: January 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: March 1, 2026
• Last Updated: December 31, 2024

Record last verified: 2024-12