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

Primary Purpose

Postoperative Pain

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ultrasound Guided Transversus Abdominis Plane Block
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Cairo universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

fentanyle

Midazolam

control

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Dose of intra-Operative fentanyl consumption
Lack of inadequate intraoperative analgesia, as defined by an increase in pulse rate, sweating, and tearing (PRST) score >2 or an increase of mean arterial blood pressure (MAP) >20% of baseline was treated by additional rescue IV fentanyl 1-2 mcg/kg IV bolus.
Block related complications
haematoma, neurological complications
Time of first analgesic request
visual analogue scale equals or more than 4
Incidence of postoperative nausea and vomiting
will be assessed using by yes/ no scale

Full Information

First Posted
June 8, 2020
Last Updated
June 10, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04426617
Brief Title
Fentanyl Versus Midazolam As Additives To Bupivacaine In Ultrasound Guided Transversus Abdominis Plane Block
Official Title
Comparison Between Fentanyl And Midazolam As Additives To Bupivacaine In Ultrasound Guided Transversus Abdominis Plane Block in Patients Undergoing Abdominal Surgeries; A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 10, 2020 (Actual)
Primary Completion Date
July 10, 2020 (Anticipated)
Study Completion Date
July 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Informed written consent will be obtained from study participants or their legally authorized representative. This is a randomized controlled double blinded study; patients will be enrolled in the study and will be randomized and equally divided into three groups: Group A: (TAP block with 20 ml of bupivacaine 0.25% and 50 μ g of fentanyl) Group B: (TAP block with 20 ml bupivacaine 0.25% and 50 μ g /kg midazolam) Group C: (TAP block with 20 ml bupivacaine 0.25% only). Induction of general anaesthesia will be performed using a regimen of IV 1 μ g/kg fentanyl and Propofol IV 2 mg /kg. Tracheal intubation will be facilitated using 0.5 mg/kg IV of atracurium. Maintenance of Anaesthesia: Anaesthesia will be maintained with inhaled sevoflurane with MAC 2% in oxygen enriched air (FiO2=0.5) and top up doses of Atracurium (0.1 mg/kg) IV will be administered every 30 minutes. Ringer acetate will be infused to replace their fluid deficit, maintenance and losses, and the patients will be mechanically ventilated using the appropriate setting that will keep the end-tidal CO2 at 30-35mmHg. One reading of mean arterial pressure (MAP) and heart rate (HR) will be taken 1 minute before induction of general anaesthesia (a baseline reading), 1 minute before surgical incision and at 15-minute intervals intra operatively. Lack of inadequate intraoperative analgesia, as defined by an increase in pulse rate, sweating, and tearing (PRST) score >2 or an increase of mean arterial blood pressure (MAP) >20% of baseline (8) was treated by additional rescue IV fentanyl 1-2 mcg/kg IV bolus. Hypotension will be treated with 0.9% normal saline and/or 5mg ephedrine in incremental doses to maintain mean blood pressure above 70 mmHg. The residual neuromuscular blockade will be reversed using neostigmine (0.05 mg/kg) and atropine (0.02 mg/kg), and extubation will be performed after complete recovery of the airway reflexes. The patient will be transferred to the post-anaesthesia care unit (PACU) where the MAP and HR will be recorded immediately upon arrival. Side effects such as local anaesthetic toxicity, postoperative nausea and vomiting (PONV), respiratory depression (respiratory rate <10/minute) will be recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
fentanyle
Arm Type
Experimental
Arm Description
: patients will receive US guided unilateral Transversus abdominis plane block (25 ml bupivacaine 0.25% & fentanyl).
Arm Title
Midazolam
Arm Type
Experimental
Arm Description
patients will receive us guided unilateral Transversus abdominis plane block (25 ml bupivacaine 0.25% & midazolam).
Arm Title
control
Arm Type
Placebo Comparator
Arm Description
patients will receive us guided unilateral Transversus abdominis plane block (25 ml bupivacaine 0.25%).
Intervention Type
Procedure
Intervention Name(s)
Ultrasound Guided Transversus Abdominis Plane Block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Onset of the Analgesic effect of TAP block with different additives
Description
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.
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Dose of intra-Operative fentanyl consumption
Description
Lack of inadequate intraoperative analgesia, as defined by an increase in pulse rate, sweating, and tearing (PRST) score >2 or an increase of mean arterial blood pressure (MAP) >20% of baseline was treated by additional rescue IV fentanyl 1-2 mcg/kg IV bolus.
Time Frame
2 hours
Title
Block related complications
Description
haematoma, neurological complications
Time Frame
24 hours
Title
Time of first analgesic request
Description
visual analogue scale equals or more than 4
Time Frame
24 hours
Title
Incidence of postoperative nausea and vomiting
Description
will be assessed using by yes/ no scale
Time Frame
24 hours postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yahia Hammad
Phone
+201114048081
Email
yahya196cm@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yahia hammad, M.D.
Organizational Affiliation
Cairo University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cairo university
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
yahia Hammad, M.D.
Phone
01224254012
Email
bassantmohamed197@yahoo.com
First Name & Middle Initial & Last Name & Degree
Shereen Moustafa, M.D.
First Name & Middle Initial & Last Name & Degree
Yahia Hammad, M.D.

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28405129
Citation
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.
Results Reference
background
PubMed Identifier
21851346
Citation
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.
Results Reference
background
PubMed Identifier
29226150
Citation
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.
Results Reference
result

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

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