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Comparing Intravenous Magnesium Sulfate With Dexamethasone as Adjuvants to Ultrasound Guided TAPblock (TAPblock)

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ultrasound guided transversus abdominis plane block
Sponsored by
Tamer Nabil Abdelrahman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

undefined - 50 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • singleton full term pregnancy ( completed 37 weeks)
  • undergoing elective cesarean section
  • ASA I, II

Exclusion Criteria:

  • patients with ASA physical status class III-IV,
  • morbid obesity with BMI > 35 kg.m-2 at initial hospital visit
  • neuro-axial anaesthesia
  • severe pre-eclampsia,
  • diabetes mellitus,
  • cardiovascular disease,
  • renal disease,
  • hypermagnesemia,
  • history of analgesic administration or intake during past 24 hours,
  • chronic use of steroids therapy,
  • urgent cesarean sections,
  • multiple gestations,
  • history of relevant drug allergy,
  • any possibility of anticipated difficult intubation.

Sites / Locations

  • AinShams University, Faculty of medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Magnesium sulfate group(M)

Dexamethasone group(D)

Placebo group(C)

Arm Description

Participants in group (M) will receive 50 mg/kg MgSO4 in 100 ml isotonic saline intravenous (I.V) over 20 minutes prior to induction of general anesthesia by 30 minutes then ultrasound guided TAPblock after closure of the abdomen

participants in group (D) will receive 2 mg Dexamethasone in 100 ml isotonic saline IV then ultrasound guided TAPblock after closure of the abdomen

participants in group (C) will receive 100 ml isotonic saline IV (placebo) by the same route and over the same duration as control then ultrasound guided TAPblock after closure of the abdomen

Outcomes

Primary Outcome Measures

Efficacy of postoperative analgesia
pain assessed by visual analogue scale from 0- 10 as 0 means no pain and 10 worst pain and 0-3 mild pain , 4-7 moderate pain and 7-10 severe pain
The duration of analgesia before needing rescue analgesia
Time in minutes
Frequency of rescue analgesia needed

Secondary Outcome Measures

fetal safety
assessed by APGAR score from 1- 10 the higher the score the better the baby health a score of 7 to 9 means normal newborn and is a sign of good health after birth
time needed to ambulate unaided
Measured in hours
patient hemodynamics
heart rate (BPM)
Patient hemodynamics
Mean arterial blood pressure(mmHg)

Full Information

First Posted
January 4, 2020
Last Updated
August 9, 2020
Sponsor
Tamer Nabil Abdelrahman
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1. Study Identification

Unique Protocol Identification Number
NCT04223128
Brief Title
Comparing Intravenous Magnesium Sulfate With Dexamethasone as Adjuvants to Ultrasound Guided TAPblock
Acronym
TAPblock
Official Title
Comparing Intravenous Single Low Doses of Magnesium Sulphate Versus Dexamethasone as Adjuvants to Ultrasound Guided Transversus Abdominis Plane (TAP) Block for Prolongation of Postcesaren Analgesia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
April 1, 2020 (Actual)
Study Completion Date
April 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tamer Nabil Abdelrahman

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
TAP block provided increased postoperative analgesia and reduced analgesic requirements as part of a multimodal analgesic regimen. The aim of the study is to compare the efficacy of single low dose of intravenous MgSO4 versus intravenous dexamethasone as adjuvants to ultrasound guided TAP block for prolongation of postcesaren analgesia
Detailed Description
Study Setting: Ain shams University maternity Hospitals, Cairo, Egypt. Study Period: 4 months from 1st December 2019 to 1st April 2020. Sampling Method: Random sample Sample Size: 60 patients Study Design A total of (60) full term pregnant women (completed 37 weeks) will be recruited for the study will undergo elective cesarean section. Written informed consent will be obtained from all patients before randomization. Randomization will be done with the help of a computer generated list of numbers. Patients will be divided randomly and equally into three groups (20) Patients each. The first group patients will be assigned to magnesium sulphate group (M), the second group of patients will be assigned to dexamethasone group (D) and the third group will be assigned to placebo group (C). Group assignment, preparation and administration of drugs will be performed by a junior anesthetist who is neither involved nor interested by any means in the study. Blind grouping will be kept to all including the patients themselves, until the completion of study. Preoperative Anesthetic Assessment All patients will be subjected to a thorough medical history, physical examination with thorough airway assessment, laboratory investigations (fasting blood sugar, kidney, liver function tests, serum electrolytes, coagulation profile, and electrocardiogram) preoperatively. They will be also counseled about the anesthetic management and potential complications of both surgery and anesthesia, and the explanations of numerical pain analogue scale (NAS) from 0-10. All these data will be documented. Anesthetic Protocol All participants will be admitted to operating theatre (OR) induction area where patient identification is confirmed and an 18-gauge intravenous cannula will be inserted to all Participants. Participants in group (M) will receive 50 mg/kg MgSO4 in 100 ml isotonic saline intravenous (I.V) over 20 minutes prior to induction of general anesthesia by 30 minutes, participants in group (D) will receive 2 mg Dexamethasone in 100 ml isotonic saline IV while participants in group (C) will receive 100 ml isotonic saline IV (placebo) by the same route and over the same duration as control. General anesthesia will be induced with intravenous propofol 2.0 mg/kg, succinyl choline 1.0 mg/Kg then they will be intubated orally which is fixed after confirmation of its place by capnography and auscultation. Anesthesia will be maintained by 2% sevoflurane in 100% oxygen then atracurium 0.1 mg/kg will be given for maintenance of muscle relaxation. After delivery of the fetus and placenta, 2 mg midazolam, 1 µg/kg fentanyl and 10 IU oxytocin (in 500 ml ringer solution) will be administrated. Immediately after completion of surgery, each patient will receive ultrasound guided bilateral ultrasound guided TAP blocks. After that muscle relaxant will be antagonized by 40 µg/kg neostigmine and 20 µg/kg atropine, then awake extubation will be done and the patients will be transferred to the recovery unit. All patients will be monitored all through the surgery by standard monitors including, electrocardiogram, the pulse oximeter, non-invasive blood pressure, and capnography. TAP Block Technique Using an 18 G Tuohy needle (80 mm Smiths medical Portex®) and the layers of the abdominal wall will be identified guided by superficial high-frequency 45 mm linear array ultrasound probe (13 MHz) as described by McDonnell and colleagues.(1) Twenty millilitre of 0.25% bupivacaine will be injected slowly after careful aspiration to ensure no vascular injury has occurred. Successful injection will produce an echo-lucent space between the muscle layers (internal oblique and transversus abdominis). All TAP blocks will be performed by the same anesthetist. Postoperative Analgesic Regimen It will start immediately on arrival to the recovery unit where all patients will receive 1 gm of Acetaminophen IV. After that all patients will continue on acetaminophen 1 gm/6 h IV and 5 mg Nalbuphine IV will be given if breakthrough pain develops during the first day postoperative. Patients Assessment Patients will be transferred to Post-anesthesia care unit PACU and upon arrival to PACU, a pulse oximeter and Non-invasive blood pressure (NIBP) monitors will be attached to the patients. Discharge criteria from PACU will be stable vital signs, pain score less than or equal to 2, no nausea or vomiting, calm and alert patient.

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
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
Group M and group D are parallel and compared to group C
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnesium sulfate group(M)
Arm Type
Active Comparator
Arm Description
Participants in group (M) will receive 50 mg/kg MgSO4 in 100 ml isotonic saline intravenous (I.V) over 20 minutes prior to induction of general anesthesia by 30 minutes then ultrasound guided TAPblock after closure of the abdomen
Arm Title
Dexamethasone group(D)
Arm Type
Active Comparator
Arm Description
participants in group (D) will receive 2 mg Dexamethasone in 100 ml isotonic saline IV then ultrasound guided TAPblock after closure of the abdomen
Arm Title
Placebo group(C)
Arm Type
Placebo Comparator
Arm Description
participants in group (C) will receive 100 ml isotonic saline IV (placebo) by the same route and over the same duration as control then ultrasound guided TAPblock after closure of the abdomen
Intervention Type
Procedure
Intervention Name(s)
Ultrasound guided transversus abdominis plane block
Intervention Description
Using an 18 G Tuohy needle (80 mm Smiths medical Portex®) and the layers of the abdominal wall will be identified guided by superficial high-frequency 45 mm linear array ultrasound probe (13 MHz) as described by McDonnell and colleagues.(1) Twenty millilitre of 0.25% bupivacaine will be injected slowly after careful aspiration to ensure no vascular injury has occurred. Successful injection will produce an echo-lucent space between the muscle layers (internal oblique and transversus abdominis). All TAP blocks will be performed by the same anesthetist.
Primary Outcome Measure Information:
Title
Efficacy of postoperative analgesia
Description
pain assessed by visual analogue scale from 0- 10 as 0 means no pain and 10 worst pain and 0-3 mild pain , 4-7 moderate pain and 7-10 severe pain
Time Frame
the first 24 hours postoperative
Title
The duration of analgesia before needing rescue analgesia
Description
Time in minutes
Time Frame
First 24 hours postoperative
Title
Frequency of rescue analgesia needed
Time Frame
First 24 hours postoperative
Secondary Outcome Measure Information:
Title
fetal safety
Description
assessed by APGAR score from 1- 10 the higher the score the better the baby health a score of 7 to 9 means normal newborn and is a sign of good health after birth
Time Frame
first minute and at 5 minutes postdelivery
Title
time needed to ambulate unaided
Description
Measured in hours
Time Frame
the first 24 hours postoperatively
Title
patient hemodynamics
Description
heart rate (BPM)
Time Frame
Immediatelypre-anesthesia, immediately postintubation, immediately postextubation and 3o minutes postrecovery
Title
Patient hemodynamics
Description
Mean arterial blood pressure(mmHg)
Time Frame
Immediatelypre-anesthesia, immediately postintubation, immediately postextubation and 3o minutes postrecovery

10. Eligibility

Sex
Female
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: singleton full term pregnancy ( completed 37 weeks) undergoing elective cesarean section ASA I, II Exclusion Criteria: patients with ASA physical status class III-IV, morbid obesity with BMI > 35 kg.m-2 at initial hospital visit neuro-axial anaesthesia severe pre-eclampsia, diabetes mellitus, cardiovascular disease, renal disease, hypermagnesemia, history of analgesic administration or intake during past 24 hours, chronic use of steroids therapy, urgent cesarean sections, multiple gestations, history of relevant drug allergy, any possibility of anticipated difficult intubation.
Facility Information:
Facility Name
AinShams University, Faculty of medicine
City
Cairo
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparing Intravenous Magnesium Sulfate With Dexamethasone as Adjuvants to Ultrasound Guided TAPblock

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