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.

NCT ID: NCT06752629

Last Updated: 2024-12-31

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2026-03-01

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

Detailed Description

The para-vertebral block has been largely used over the past years for post-operative analgesia. Many reports in the literature describe the use of thoracic paravertebral block for providing post-laparoscopic cholecystectomy analgesia. Thanks to the ultrasound, over the past years, paravertebral blocks (PVB) have been increasingly used for providing postoperative analgesia, and in the administration of thoracic paravertebral block which has greatly reduced the incidence of associated complications.

Contrary to the intra-abdominal instillation of local anesthetics and local infiltration, the paravertebral blockade has been reported to provide high-quality afferent blockade with the abolishment of somatosensory evoked potentials. and has also been found capable of attenuating the postoperative stress response associated with traditional cholecystectomy.

Conditions

Laparoscopic Cholecystectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

group 1

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

Group Type: EXPERIMENTAL

Bupivacaine and Dexmedetomidine

Intervention Type: DRUG

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

group 2

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

Group Type: EXPERIMENTAL

Bupivacaine and Fentanyl

Intervention Type: DRUG

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

Interventions

Bupivacaine and Dexmedetomidine

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

Intervention Type: DRUG

Bupivacaine and Fentanyl

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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• ● 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Eithar Mahmoud Abd-Elsalm

resident doctor at Assiut University hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Eithar Mahmoud Abd-Elsalm, resident doctor

Role: CONTACT

ethar.16266036@med.aun.edu.eg

+201220805991

Other Identifiers

dexm VS fenta cholecystectomy

Identifier Type: -

Identifier Source: org_study_id