Dexmedetomidine Versus Fentanyl Added to Levobupivacaine for Transversus Abdominis Plane (TAP) Block

Sponsor

Assiut University (Other)

Overall Status

Completed

CT.gov ID

NCT03778671

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The perioperative management of pain following lower abdominal surgery can pose a challenge to anesthesia providers. Conventional practice has involved the use of opioids as well as neuraxial analgesic techniques. Unfortunately, these therapies are not without potential risks and side effects. These include nausea, vomiting, pruritus, urinary retention, constipation, respiratory depression, and sedation.

Condition or Disease	Intervention/Treatment	Phase
Transversus Abdominis Block	Drug: Levobupivacaine Drug: Dexmedetomidine Injection [Precedex] Drug: fentanyl	Phase 1/Phase 2

Detailed Description

One method used in this multimodal approach is the transversus abdominis plane block. This block, as first described by Rafi. in 2001, provides analgesia to the anterolateral abdominal wall. In 2007, McDonnell et al. further studied this technique in patients undergoing large-bowel resection. He discovered a reduction in postoperative pain and morphine consumption in the first 24 hours postoperatively, resulting in fewer opioid mediated side effects. In this same year, Hebbard et al. described the use of ultrasound guidance to provide real-time imaging of the muscle layers and needle placement to improve transversus abdominis plane block accuracy. In 2008, Hebbard. described the subcostal approach of transversus abdominis plane block, to target the nerves of the upper abdomen. Transversus abdominis plane blocks continue to be studied and developed as an effective method for providing analgesia for numerous types of transverses abdominis plane block duration is limited to effect of administered local anesthetics.The use of an infusion catheter to administer local anesthetics is an option to prolong the block's duration. Recently, adjuvant medications were added to local anesthetics to prolong the effect of transverses abdominis plane block .

Study Design

Study Type:

Interventional

Actual Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

Dexmedetomidine Versus Fentanyl Added to Levobupivacaine for Transversus Abdominis Plane (TAP) Block in Elderly Patients Undergoing Lower Abdominal Surgery

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

Nov 1, 2019

Actual Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Group B Patients will receive Levobupivacaine 5%	Drug: Levobupivacaine Patients will receive Levobupivacaine 5% Other Names: Levobupivacaine hydrate
Active Comparator: Group D Patients will receive Levobupivacaine 5% + 1 µg/kg dexmedetomedine .	Drug: Dexmedetomidine Injection [Precedex] Patients will receive Levobupivacaine 5% + 1 µg/kg dexmedetomedine
Active Comparator: Group F Patients will receive Levobupivacaine 5% + 1µg/kg fentanyl	Drug: fentanyl Patients will receive Levobupivacaine 5% + 1 µg/kg fentanyl

Arm

Intervention/Treatment

Experimental: Group B

Patients will receive Levobupivacaine 5%

Drug: Levobupivacaine

Patients will receive Levobupivacaine 5%

Other Names:

Levobupivacaine hydrate

Active Comparator: Group D

Patients will receive Levobupivacaine 5% + 1 µg/kg dexmedetomedine .

Drug: Dexmedetomidine Injection [Precedex]

Patients will receive Levobupivacaine 5% + 1 µg/kg dexmedetomedine

Active Comparator: Group F

Patients will receive Levobupivacaine 5% + 1µg/kg fentanyl

Drug: fentanyl

Patients will receive Levobupivacaine 5% + 1 µg/kg fentanyl

Outcome Measures

Primary Outcome Measures

first analgesic request [24 hours]
first time to call for analgesia

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

ASA physical status II-III,
scheduled for uncomplicated elective paraumbilical hernia repair.

Exclusion Criteria:

Patient refusal to participate in the study
Patients with coagulopathy or under anticoagulation therapy.
Infection near the site of needle insertion.
Body mass index > 40kg/m2
Patients with any neurological or neuromuscular disorder or history of seizures.