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

NCT04223128 | Completed

• 1 other identifier: FAMSU R 59/2019
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (3)

• 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 first 24 hours postoperative

• The duration of analgesia before needing rescue analgesia

  Time in minutes

  First 24 hours postoperative

• Frequency of rescue analgesia needed

  First 24 hours postoperative

Secondary Outcomes (4)

• fetal safety

  first minute and at 5 minutes postdelivery

• time needed to ambulate unaided

  the first 24 hours postoperatively

• patient hemodynamics

  Immediatelypre-anesthesia, immediately postintubation, immediately postextubation and 3o minutes postrecovery

• Patient hemodynamics

  Immediatelypre-anesthesia, immediately postintubation, immediately postextubation and 3o minutes postrecovery

Study Arms (3)

Magnesium sulfate group(M)

ACTIVE COMPARATOR

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

Procedure: Ultrasound guided transversus abdominis plane block

Dexamethasone group(D)

ACTIVE COMPARATOR

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

Procedure: Ultrasound guided transversus abdominis plane block

Placebo group(C)

PLACEBO COMPARATOR

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

Procedure: Ultrasound guided transversus abdominis plane block

Interventions

Ultrasound guided transversus abdominis plane block PROCEDURE

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.

Dexamethasone group(D); Magnesium sulfate group(M); Placebo group(C)

Eligibility Criteria

• Age: Up to 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tamer Nabil Abdelrahman: lead

Study Sites (1)

AinShams University, Faculty of medicine

Cairo, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of anesthesia, intensive care and pain management

Model Details: Group M and group D are parallel and compared to group C

Study Record Dates

• First Submitted: January 4, 2020
• First Posted: January 10, 2020
• Study Start: December 1, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 3, 2020
• Last Updated: August 11, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)