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Analgesic Efficacy of Dexamethasone in Different Routes of Administration in Transverse Abdominis Plane Block

Effect of Perineural Versus Intravenous Dexamethasone On Analgesic Efficacy of Transverse Abdominis Plane Block With Levobupivacaine In Laparoscopic Gynaecological Procedures: A Randomized, Double-Blind Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02838719
Acronym
AEDDATB
Enrollment
40
Registered
2016-07-20
Start date
2014-12-31
Completion date
2015-12-31
Last updated
2016-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

INFERTILITY

Brief summary

Transverse abdominis plane (TAP) block is a regional anaesthesia technique that provides analgesia to the parietal peritoneum as well as skin and muscles of the anterior abdominal wall. In the past, a number of adjuvants have been added to the local anaesthetics in peripheral and neuraxial blocks resulting in an effective and long lasting analgesia.In recent times, dexamethasone has been increasingly used as an adjuvant to local anaesthetics in peripheral nerve blocks. Dexamethasone has a long and efficient glucocorticoid structure and also has anti-inflammatory property. It also blocks the C- fibers of pain pathway. When added to local anaesthetics as an adjuvant in peripheral nerve blocks, it has shown to prolong the analgesia time. A number of previous studies have also shown an opioid sparing effect of steroids, when used intravenously perioperatively. Though previous studies have shown that addition of dexamethasone to local anaesthetics in transverse abdominis plane block prolongs the duration of block, however it is not known whether this effect of dexamethasone is due to its peripheral action or because of its systemic absorption. Thus, in this study planned to compare the effectiveness of dexamethasone on quality and duration of analgesia when used as an adjuvant with local anaesthetics in transverse abdominis plane block versus when given systemically by intravenous route along with transverse abdominis plane block using local anaesthetics only, in patients undergoing gynaecological laparoscopic procedures under general anaesthesia.

Interventions

DRUGPerineural Dexamethasone acetate
DRUGIntravenous dexamethasone acetate

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

1. Women aged between 18 to 70 years undergoing gynaecological laparoscopic surgeries under general anaesthesia 2. ASA physical status1 or 2

Exclusion criteria

1. Local infection 2. Morbid obesity (body mass index \>35kg/m2) 3. Allergy to local anaesthetics 4. Patient refusal 5. Severe respiratory or cardiac disorders 6. Pre-existing neurological deficits 7. Liver or renal insufficiency 8. Preexisting diabetics 9. Patient on steroid treatment for any reason. 10. Peri Operative use of steroids

Design outcomes

Primary

MeasureTime frameDescription
Time to first rescue analgesicfirst 24 hoursPain will be assessed by vas score, if vas score more than 3 rescue analgesia will be given. Duration between the end of anaesthesia to first analgesic requirement during first 24 hours of postoperative period.

Secondary

MeasureTime frameDescription
Total amount of rescue analgesic required in 1st 24 hours postoperatively0, 0.25, 0.50, 0.75, 1 , 2, 4, 6, 8,12, 24 hoursPain will be assessed by vas score, if vas score more than 3 rescue analgesia will be given.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026