Role of Dexamethasone in Transversus Abdominis Plane Block After Cesarean Section

NCT03767920 | Completed

• 1 other identifier: aswu/180/7/18
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Our aim to study the efficacy of bupivacaine 0.25% with dexamethasone and that of bupivacaine 0.25% alone in transversus abdominis plane (TAP) block for postoperative analgesia in patients undergoing an elective Caesarean section.

• Group 1: bupivacaine 0.25% + dexamethasone 8 mg
• Group 2: bupivacaine 0.25% A prospective Randomized Interventional double-blind study.

Conditions

Cesarean Section

Keywords

dexamethasone; transversus abdominis plane block; cesarean section

Outcome Measures

Primary Outcomes (1)

• Visual analog score for pain during movement

  movement-evoked pain measurements ranging from 0 to 10, where 0 no pain and 10 maximum pain

  6 hours post operative

Secondary Outcomes (3)

• Visual analog score during rest

  48 hours postoperative

• number of patients need Fentanyl consumption

  48 hours postoperative

• number of days patients stay in hospital

  4 weeks

Study Arms (2)

bupivacaine and dexamethasone

ACTIVE COMPARATOR

Bilateral TAP block with 20 ml of 0.25% bupivacaine + 4 mg/kg dexamethasone diluted with isotonic saline.

Drug: bupivacaine; Drug: dexamethasone

bupivacaine and placebo to dexamethasone

ACTIVE COMPARATOR

BilateralTAP block with 20 ml of 0.25% bupivacaine bilaterally plus placebo to dexamethasone

Drug: bupivacaine; Drug: placebo to dexamethasone

Interventions

bupivacaine DRUG

TAP block with 20 ml of 0.25% bupivacaine bilaterally

Also known as: Active Comparator

bupivacaine and dexamethasone; bupivacaine and placebo to dexamethasone

dexamethasone DRUG

TAP block with 4 mg dexamethasone bilaterally

Also known as: active comparator

bupivacaine and dexamethasone

placebo to dexamethasone DRUG

TAP block with 4 mg placebo to dexamethasone bilaterally

Also known as: Placebo

bupivacaine and placebo to dexamethasone

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: healthy parturient scheduled to undergo LSCS under spinal anesthesia
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• healthy parturient (ASA I and II) scheduled to undergo LSCS under spinal anesthesia

You may not qualify if:

• Participants had known sensitivity to bupivacaine
• patient refusal,
• localized infection over injection point
• patients with significant coagulopathies and
• with contraindications to regional anesthesia,
• patients with heart diseases, altered renal or liver functions,
• psychological disorders, patients with pregnancy-induced hypertension and
• gestational diabetes, chronic use of pain medications,

Sponsors & Collaborators

• Aswan University Hospital: lead

Study Sites (1)

Aswan University

Aswān, 81528, Egypt

Location

MeSH Terms

Interventions

Bupivacaine; Dexamethasone

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• hany f sallam, md

  Aswan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participating patients, surgeons, anesthesiologists and medical investigators who will be involved in the data collection will be all blinded to the patient's group assignment until the collection of data for all cases will be complete.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A prospective Randomized Interventional double-blind study.

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 7, 2018
• Study Start: January 1, 2019
• Primary Completion: March 30, 2020
• Study Completion: August 1, 2020
• Last Updated: August 5, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)