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

NCT ID: NCT06292273

Last Updated: 2024-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-10
• Study Completion Date: 2024-02-20

Brief Summary

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.

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.

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group Bupivacain Plus dexamethasone

receiving plain bupivacaine 0.1%, 35 ml with dexmedetomidine 0.5

Group Type: ACTIVE_COMPARATOR

Transversus Abdominis Plane Block with bupivacain Plus dexamethasone

Intervention Type: PROCEDURE

Bupivacain 0.1%, 35 ml with dexmedetomidine 0.5 µG/kg on each side

Group bupivacain

plain bupivacaine 0.25%, 25 ml bilaterally

Group Type: PLACEBO_COMPARATOR

Transversus Abdominis Plane Block with bupivacain

Intervention Type: PROCEDURE

plain bupivacaine 0.25%, 25 ml bilaterally

Interventions

Transversus Abdominis Plane Block with bupivacain Plus dexamethasone

Bupivacain 0.1%, 35 ml with dexmedetomidine 0.5 µG/kg on each side

Intervention Type: PROCEDURE

Transversus Abdominis Plane Block with bupivacain

plain bupivacaine 0.25%, 25 ml bilaterally

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• pregnant female elected for cesarean section
• ASAll

Exclusion Criteria

• coagulopathy
• BMI>35

• heart Diseases
• diabets

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Menoufia University

OTHER

Sponsor Role: lead

Responsible Party

rabab Mohammad habeeb

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

rabab M habeeb

Role: PRINCIPAL_INVESTIGATOR

Menoufia University

Locations

Faculty of Medicine Menoufia University

Cairo, Governorate, Egypt

Countries

Egypt

Other Identifiers

ANET19

Identifier Type: -

Identifier Source: org_study_id