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.

Assiut University

Status and phase: Not yet enrolling; Phase 4

Conditions: Laparoscopic Cholecystectomy

Treatments: Drug: Bupivacaine and Dexmedetomidine; Drug: Bupivacaine and Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT06752629

dexm VS fenta cholecystectomy

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

group 1

Experimental group

Description:

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

Treatment:

Drug: Bupivacaine and Dexmedetomidine

group 2

Experimental group

Description:

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

Treatment:

Drug: Bupivacaine and Fentanyl