Dexamethasone With TAP Block Increasing the Duration of the Peripheral Nerve Block in Caesarian Section

Pain Clinical Trial

Official title:

Dexamethasone With TAP Block Increasing the Duration of the Peripheral Nerve Block in Caesarian Section

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02440880
• Other study ID #: Qasr Elainy
• Status: Recruiting
• Phase: N/A
• First received: April 24, 2015
• Last updated: August 2, 2016
• Start date: May 2015
• Est. completion date: January 2017

Study information

• Verified date: August 2016
• Source: Cairo University
• Contact: Hassan Ali
• Phone: +201001733687
• Email: hassan364[@]hotmail.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial Summary

Nowadays Cesarean sections became the most popular surgery worldwide with the consumption of the hospital resources and the continuous need to decrease the costs, work load and medical stuff engagement. One of the most common problem is the need to control pain post operatively, this issue increase the work load over the pain management team and increase lead to patient in satisfaction.

This study will test the usage of dexamethasone with different doses (4 and 8 mg) either locally or intravenously (I.V.) with the local anesthetics in TAP (transversus abdominis plane) block to prolong the duration of the block and decrease the need of post-operative analgesics.

Description:

Nowadays Cesarean sections became the most popular surgery worldwide with the consumption of the hospital resources and the continuous need to decrease the costs, work load and medical stuff engagement. One of the most common problem is the need to control pain post operatively, this issue increase the work load over the pain management team and increase lead to patient in satisfaction.(1,2,3) The presence of the adjuvant which can be added to the conventional anesthetic medications can prolong the duration of action and decrease the need for frequent post-operative analgesics.(4,5) The idea of adding a catheter or placing an epidural catheter still have a quite limitation regarding the patients compliance, delayed ambulation and high costs, these limitations redirect the anesthetist again to the use of adjuvant with a single shot block to prolong the duration of it and decrease the need of subsequent analgesics.(6) Dexamethasone proved to be an effective adjuvant in prolongation of the nerve blocks with the question regarding the proper route and dose (7,8,9,10).

This study will test the usage of dexamethasone with different doses (4 and 8 mg) either locally or intravenously (I.V.) with the local anesthetics in TAP (transversus abdominis plane) block to prolong the duration of the block and decrease the need of post-operative analgesics.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Any patient ASA (american society of anesthesia) I or II,

• aged between 18 and 45 scheduled for elective cesarean section.

Exclusion Criteria:

• patient refusal,

• age below 18 or above 45 years,

• coagulopathy with INR (international normalized ratio) more than 1.5 or platelets below 100000,

• uncontrolled diabetes, uncontrolled hypertensive, addict patient,

• psychological instability, and

• allergy to the used drugs,

• failure of spinal,

• conversion to general of anesthesia,

• failure of application of TAP block.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Dexamethasone in addition to TAP block in dose of 4 mg
Dexamethasone in addition to TAP block in dose of 4 mg
• Dexamethasone in combination with TAP block in dose of 8 mg
Dexamethasone in combination with TAP block in dose of 8 mg
• Dexamethasone intravenous 4mg+ TAP block
Dexamethasone intravenous in addition to TAP block in dose of 4 mg
• Dexamethasone intravenous in addition to TAP block in dose of 8 mg
Dexamethasone intravenous + TAP block in dose of 8 mg

Other:
• control
TAP block without Dexamethasone neither intravenous nor in combination with the block

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo	Giza

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	level of pain according to verbal analogue scale		THREE DAYS	Yes