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

NCT ID: NCT02440880

Last Updated: 2016-08-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-01-31

Brief 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.

Detailed 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.

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

CONTROL

TAP block without Dexamethasone neither intravenous nor in combination with the block

Group Type: PLACEBO_COMPARATOR

control

Intervention Type: OTHER

TAP block without Dexamethasone neither intravenous nor in combination with the block

Group 2 (TD8IS)

Dexamethasone in combination with TAP block in dose of 8 mg

Group Type: EXPERIMENTAL

Dexamethasone in combination with TAP block in dose of 8 mg

Intervention Type: DRUG

Dexamethasone in combination with TAP block in dose of 8 mg

Group 3(TD4IS)

Dexamethasone in addition to TAP block in dose of 4 mg

Group Type: EXPERIMENTAL

Dexamethasone in addition to TAP block in dose of 4 mg

Intervention Type: DRUG

Dexamethasone in addition to TAP block in dose of 4 mg

Group 4 (TSID8):

Dexamethasone intravenous in addition to TAP block in dose of 8 mg

Group Type: EXPERIMENTAL

Dexamethasone intravenous in addition to TAP block in dose of 8 mg

Intervention Type: DRUG

Dexamethasone intravenous + TAP block in dose of 8 mg

Group5(TSID4)

Dexamethasone intravenous 4mg+ TAP block

Group Type: EXPERIMENTAL

Dexamethasone intravenous 4mg+ TAP block

Intervention Type: DRUG

Dexamethasone intravenous in addition to TAP block in dose of 4 mg

Interventions

Dexamethasone in addition to TAP block in dose of 4 mg

Dexamethasone in addition to TAP block in dose of 4 mg

Intervention Type: DRUG

Dexamethasone in combination with TAP block in dose of 8 mg

Dexamethasone in combination with TAP block in dose of 8 mg

Intervention Type: DRUG

Dexamethasone intravenous 4mg+ TAP block

Dexamethasone intravenous in addition to TAP block in dose of 4 mg

Intervention Type: DRUG

Dexamethasone intravenous in addition to TAP block in dose of 8 mg

Dexamethasone intravenous + TAP block in dose of 8 mg

Intervention Type: DRUG

control

TAP block without Dexamethasone neither intravenous nor in combination with the block

Intervention Type: OTHER

Other Intervention Names

Dexamethasone intravenous 4mg + TAP block; Dexamethasone intravenous 8mg+ TAP block; control group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Hassan Mohamed Ali

lecturer in anesthesia department Cairo university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hassan Ali, LECTURER

Role: PRINCIPAL_INVESTIGATOR

Anesthesia department, faculty of medicine ,Cairo university

Locations

Cairo University

Cairo, Giza Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Hassan Ali

Role: CONTACT

hassan364@hotmail.com

+201001733687

Facility Contacts

HASSAN M ALI, LECTURER

Role: primary

hassan364@hotmail.com

+201001733687

Other Identifiers

Qasr Elainy

Identifier Type: -

Identifier Source: org_study_id