Fentanyl Versus Midazolam As Additives To Bupivacaine In Ultrasound Guided Transversus Abdominis Plane Block

NCT04426617 | Completed

• 1 other identifier: MS-258-2019
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Pain triggers a complex biochemical and physiological stress response leading to impairment of pulmonary, immunological and metabolic functions. The Transversus Abdominis Plane (TAP) block, is a regional anaesthesia technique used for various surgeries through the lower to mid-abdominal wall.The addition of fentanyl to the local anaesthetic in ultrasound-guided TAP block prolongs the analgesia, lowers postoperative pain, and decreases the opioid consumption. Adding midazolam as a bupivacaine adjuvant for TAP block reduces the 24-h morphine consumption extends the postoperative analgesia duration. The aim of the work is to study the effect of the addition fentanyl and midazolam on the onset, duration of the analgesic effect of Tap block intraoperative fentanyl consumption, Time for first rescue Analgesia. in patients undergoing simple unilateral abdominal surgeries.

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

• Onset of the Analgesic effect of TAP block with different additives

  The patient will be asked to register a prick respectively on the upper extremity. Sensory change will then be assessed in the mid-clavicular line, starting above dermatome T4 moving caudally to dermatome L4.

  30 minutes

Secondary Outcomes (4)

• Dose of intra-Operative fentanyl consumption

  2 hours

• Block related complications

  24 hours

• Time of first analgesic request

  24 hours

• Incidence of postoperative nausea and vomiting

  24 hours postoperative

Study Arms (3)

fentanyle

EXPERIMENTAL

: patients will receive US guided unilateral Transversus abdominis plane block (25 ml bupivacaine 0.25% \& fentanyl).

Procedure: Ultrasound Guided Transversus Abdominis Plane Block

Midazolam

EXPERIMENTAL

patients will receive us guided unilateral Transversus abdominis plane block (25 ml bupivacaine 0.25% \& midazolam).

Procedure: Ultrasound Guided Transversus Abdominis Plane Block

control

PLACEBO COMPARATOR

patients will receive us guided unilateral Transversus abdominis plane block (25 ml bupivacaine 0.25%).

Procedure: Ultrasound Guided Transversus Abdominis Plane Block

Interventions

Ultrasound Guided Transversus Abdominis Plane Block PROCEDURE

The patient will lie in the supine position. The transducer will be placed in the axial plane on the mid-axillary. transversus abdominis muscle will be visualized. A skin wheel using 3 ml of lidocaine 1 % is made 2 to 3 cm medial to the medial aspect of the transducer and the 22 gauge is inserted in-plane pointing laterally. Then Injection of local anaesthetic mixure in the right plane.

Midazolam; control; fentanyle

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Physical status ASA I and ASA ll.
• Age ≥ 18 and ≤ 65 Years.
• Body mass index (BMI): ≥ 20 kg/m2 and ≤ 35 kg/m2.
• Patients undergoing Abdominal Surgeries.
• Patient is able to provide a written informed consent.

You may not qualify if:

• Known sensitivity to local anaesthetics.
• Significant liver or renal insufficiency.
• Contraindication to regional anaesthesia e.g. local - sepsis, pre-existing peripheral neuropathies and coagulopathy.
• Patient refusal.
• Failed Block.

Sponsors & Collaborators

• Bassant M. Abdelhamid: lead

Study Sites (1)

Cairo university

Cairo, Egypt

Location

Related Publications (3)

• Nehra P, Oza V, Parmar V, Fumakiya P. Effect of Addition of Fentanyl and Clonidine to Local Anesthetic Solution in Peribulbar Block. J Pharmacol Pharmacother. 2017 Jan-Mar;8(1):3-7. doi: 10.4103/jpp.JPP_109_16.

  PMID: 28405129 BACKGROUND

• Carney J, Finnerty O, Rauf J, Bergin D, Laffey JG, Mc Donnell JG. Studies on the spread of local anaesthetic solution in transversus abdominis plane blocks. Anaesthesia. 2011 Nov;66(11):1023-30. doi: 10.1111/j.1365-2044.2011.06855.x. Epub 2011 Aug 18.

  PMID: 21851346 BACKGROUND

• Tsai HC, Yoshida T, Chuang TY, Yang SF, Chang CC, Yao HY, Tai YT, Lin JA, Chen KY. Transversus Abdominis Plane Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:8284363. doi: 10.1155/2017/8284363. Epub 2017 Oct 31.

  PMID: 29226150 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• yahia hammad, M.D.

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 11, 2020
• Study Start: June 10, 2020
• Primary Completion: February 1, 2024
• Study Completion: June 15, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)