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

Cairo University (CU) logo

Cairo University (CU)

Status

Unknown

Conditions

Pain

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02440880
Qasr Elainy

Details and patient eligibility

About

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.

Full 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.

Enrollment

150 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

150 participants in 5 patient groups, including a placebo group

CONTROL
Placebo Comparator group
Description:
TAP block without Dexamethasone neither intravenous nor in combination with the block
Treatment:
Other: control
Group 2 (TD8IS)
Experimental group
Description:
Dexamethasone in combination with TAP block in dose of 8 mg
Treatment:
Drug: Dexamethasone in combination with TAP block in dose of 8 mg
Group 3(TD4IS)
Experimental group
Description:
Dexamethasone in addition to TAP block in dose of 4 mg
Treatment:
Drug: Dexamethasone in addition to TAP block in dose of 4 mg
Group 4 (TSID8):
Experimental group
Description:
Dexamethasone intravenous in addition to TAP block in dose of 8 mg
Treatment:
Drug: Dexamethasone intravenous in addition to TAP block in dose of 8 mg
Group5(TSID4)
Experimental group
Description:
Dexamethasone intravenous 4mg+ TAP block
Treatment:
Drug: Dexamethasone intravenous 4mg+ TAP block

Trial contacts and locations

1

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Central trial contact

Hassan Ali

Data sourced from clinicaltrials.gov

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