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

NCT ID: NCT03778671

Last Updated: 2021-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2019-12-01

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.

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 .

Conditions

Transversus Abdominis Block

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group B

Patients will receive Levobupivacaine 5%

Group Type: EXPERIMENTAL

Levobupivacaine

Intervention Type: DRUG

Patients will receive Levobupivacaine 5%

Group D

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

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine Injection [Precedex]

Intervention Type: DRUG

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

Group F

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

Group Type: ACTIVE_COMPARATOR

fentanyl

Intervention Type: DRUG

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

Interventions

Levobupivacaine

Patients will receive Levobupivacaine 5%

Intervention Type: DRUG

Dexmedetomidine Injection [Precedex]

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

Intervention Type: DRUG

fentanyl

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

Intervention Type: DRUG

Other Intervention Names

Levobupivacaine hydrate

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

1. Patient refusal to participate in the study

2. Patients with coagulopathy or under anticoagulation therapy.

3. Infection near the site of needle insertion.

4. Body mass index > 40kg/m2

5. Patients with any neurological or neuromuscular disorder or history of seizures.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Ghada Mohammed AboelFadl

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut governorate

Asyut, , Egypt

Countries

Egypt

References

Elvir-Lazo OL, White PF. The role of multimodal analgesia in pain management after ambulatory surgery. Curr Opin Anaesthesiol. 2010 Dec;23(6):697-703. doi: 10.1097/ACO.0b013e32833fad0a.

Reference Type: BACKGROUND

PMID: 20847690 (View on PubMed)

White PF, Kehlet H. Improving postoperative pain management: what are the unresolved issues? Anesthesiology. 2010 Jan;112(1):220-5. doi: 10.1097/ALN.0b013e3181c6316e. No abstract available.

Reference Type: BACKGROUND

PMID: 20010418 (View on PubMed)

Sharma P, Chand T, Saxena A, Bansal R, Mittal A, Shrivastava U. Evaluation of postoperative analgesic efficacy of transversus abdominis plane block after abdominal surgery: A comparative study. J Nat Sci Biol Med. 2013 Jan;4(1):177-80. doi: 10.4103/0976-9668.107286.

Reference Type: BACKGROUND

PMID: 23633858 (View on PubMed)

McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f.

Reference Type: BACKGROUND

PMID: 17179269 (View on PubMed)

Aditianingsih D, Mochtar CA, Chandra S, Sukmono RB, Soamole IW. Comparison of Three-Quadrant Transversus Abdominis Plane Block and Continuous Epidural Block for Postoperative Analgesia After Transperitoneal Laparoscopic Nephrectomy. Anesth Pain Med. 2018 Sep 3;8(5):e80024. doi: 10.5812/aapm.80024. eCollection 2018 Oct.

Reference Type: BACKGROUND

PMID: 30533391 (View on PubMed)

Other Identifiers

17300222

Identifier Type: -

Identifier Source: org_study_id