Bupivacaine With Dexmedetomidine Versus Bupivacaine Alone for Transversus Abdominis Plane Block in Caesarean Section

Bupivacaine With Dexmedetomidine Versus Bupivacaine Alone for Transversus Abdominis Plane Block for Post-operative Analgesia in Patients Undergoing Caesarean Section: A Comparative Study.

Transversus Abdominis plane (TAP) block is a regional technique for providing analgesia of the anterolateral abdominal wall. TAP block are commonly given in patients who have undergone various abdominal as well as pelvic surgeries such as caesarean section, hysterectomy, appendicectomy and various laparoscopic surgeries. this study is conducted to analyse the effect of addition of dexmedetomidine to bupivacaine in Transversus Abdominis Plane (TAP) block.

Study Overview

• Status: Completed
• Conditions: Post Operative Pain
• Intervention / Treatment: Procedure: Transversus Abdominis Plane Block with bupivacain Plus dexamethasone; Procedure: Transversus Abdominis Plane Block with bupivacain

Detailed Description

Peripheral nerve block is becoming increasingly popular technique for postoperative pain relief and is also established as a part of multimodal analgesia and enhanced recovery program. Transversus abdominis plane (TAP) block is a regional technique for providing analgesia of the anterolateral abdominal wall. TAP block are commonly given in patients who have undergone various abdominal as well as pelvic surgeries such as caesarean section, hysterectomy, appendicectomy and various laparoscopic surgeries.The Purpose of a TAP block is to infiltrate local anaesthetic agents in the plane between the internal oblique and transversus abdominis muscles thereby providing effective postoperative analgesia. Earlier the blind TAP block (through lumbar triangle of Petit) was commonly given but with widespread use of ultrasound nowadays it is almost always given under ultrasound guidance. Accuracy and efficacy of TAP block is significantly improved under ultrasound guidance because under ultrasound guidance the anesthetic agent can be properly deposited in the neurovascular plane. Ultrasound provides real time and direct visualisation of needle during infiltration of local anaesthetic drug.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Governorate
    • Cairo, Governorate, Egypt, 32511
      • Faculty of Medicine Menoufia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• pregnant female elected for cesarean section
• ASAll

Exclusion Criteria:

• coagulopathy

• BMI>35

  • heart Diseases
  • diabets

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group Bupivacain Plus dexamethasone; receiving plain bupivacaine 0.1%, 35 ml with dexmedetomidine 0.5	Procedure: Transversus Abdominis Plane Block with bupivacain Plus dexamethasone; Bupivacain 0.1%, 35 ml with dexmedetomidine 0.5 µG/kg on each side
Placebo Comparator: Group bupivacain; plain bupivacaine 0.25%, 25 ml bilaterally	Procedure: Transversus Abdominis Plane Block with bupivacain; plain bupivacaine 0.25%, 25 ml bilaterally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post operative pain	visual analog score from 0 to 10 where 0 is no pain and 10 worst pain ever	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sedation	Modefied Ramsey sedation score from 1 to 6	24 hours
Heart rate	pulse/ min	24 hours
Total analgesic consumption	Mg	24 hours
Side effects	Nausea, vomiting, pruritus	24hours

Collaborators and Investigators

• Sponsor: Menoufia University
• Investigators: Principal Investigator: rabab M habeeb, Menofia University

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2023
• Primary Completion (Actual): February 1, 2024
• Study Completion (Actual): February 20, 2024

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: March 2, 2024
• First Posted (Actual): March 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 2, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Anesthetics, Local; Dexamethasone; Bupivacaine
• Other Study ID Numbers: ANET19

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No