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

Post Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06292273
• Other study ID #: ANET19
• Status: Completed
• Phase: N/A
• Start date: October 10, 2023
• Est. completion date: February 20, 2024

Study information

• Verified date: March 2024
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 20, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• pregnant female elected for cesarean section

• ASAll

Exclusion Criteria:

• coagulopathy

• BMI>35

• heart Diseases

• diabets

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Procedure:
• Transversus Abdominis Plane Block with bupivacain Plus dexamethasone
Bupivacain 0.1%, 35 ml with dexmedetomidine 0.5 µG/kg on each side
• Transversus Abdominis Plane Block with bupivacain
plain bupivacaine 0.25%, 25 ml bilaterally

Locations

Country	Name	City	State
Egypt	Faculty of Medicine Menoufia University	Cairo	Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post operative pain	visual analog score from 0 to 10 where 0 is no pain and 10 worst pain ever	24 hours
Secondary	Sedation	Modefied Ramsey sedation score from 1 to 6	24 hours
Secondary	Heart rate	pulse/ min	24 hours
Secondary	Total analgesic consumption	Mg	24 hours
Secondary	Side effects	Nausea, vomiting, pruritus	24hours