Plasma ropivacaine concentrations and duration of sensory block after ultrasound-guided transversus abdominis plane block, with and without additives (adrenaline and clonidine), for gynaecological surgery

Plasma ropivacaine levels and duration of sensory block in women undergoing gynaecological surgery and having ultrasound-guided transversus abdominis blocks with ropivacaine and additives (clonidine and adrenaline) vs ropivacaine alone

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000587606

Enrollment

Registered

2014-06-03

Start date

2014-06-16

Completion date

2015-11-30

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

The purpose of this study is to assess how clonidine as an additive to local anaesthetics works when used for abdominal wall pain blocks (transversus abdominis plane blocks) after gynaecological surgery. One hypothesis is that it causes blood vessel constriction and slows the washout of local anaesthetic into the blood stream, therefore leaving it at its site of action for longer. We will assess this by measuring the levels of local anaesthetic in the blood over time. Simultaneously, we will assess the abdominal wall sensation to determine if and by how long clonidine improves the duration of postoperative pain relief in these patients.

Interventions

Ultrasound-guided transversus abdominis plane blocks using either: - Ropivacaine 3mg/kg with 1:400,000 adrenaline - Ropivacaine 3mg/kg with clonidine 2mcg/kg - Ropivacaine 3mg/kg plus clonidine 2mcg/kg subcutaneous

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

Adult female patients, aged 18 to 65, undergoing elective gynaecological surgery and who are planned to receive TAP blocks

Exclusion criteria

Allergy to any of the drugs in the study, morbid obesity, infection at site of block placement, pre-existing neurological or muscular disease, coagulopathy, significant liver or renal disease, and pregnancy.

Outcome results