Analgesia outcome of surgically guided regional anaesthesia technique versus wound infiltration of 80 patients undergoing elective Lower Uterine Caesarean Section (LUCS) under Spinal anaesthesia

Analgesia outcome of surgically guided direct vision Transversus Abdominis Plane TAP block v standard surgical infiltration of Pfannenstiel wound during elective LUCS under Neuraxial Blockade ( NAB) anesthesia - a randomised controlled trial involving 80 participants

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616001262493

Acronym

WIVSGTAP

Enrollment

Registered

2016-09-08

Start date

2016-09-30

Completion date

2017-08-31

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

This study is comparing the analgesia outcome of surgically guided direct vision Transverses Abdominis Plain ( TAP) block versus standard surgical infiltration of Pfannenstiel wound during elective Lower Uterine caesarean Section (LUCS) delivery via the Pfannenstiel incision, under Neuraxial Blockade (NAB) anaesthesia at 2, 6, 12, 24, and 48 hours postoperatively. The Null hypothesis is that there is no difference in analgesic outcome between these two techniques. The study will also seek to compare post operative nausea and vomiting PONV rates, sedation, pruritis and patient satisfaction score between these two groups. It will also look at ease of instillation of the Local anaesthetic in the correct plane and whether this correlates to analgesia outcome.

Interventions

2.5mg/kg Ropivacaine (up to maximum of 200mg) based on booking weight, diluted to 40ml, then injected under the Transversus Abdominis Plane 20 ml each side The Ropivacaine will be injected by the surgeon under direct surgical vision The injection will be administered prior to the final layers of tissue being sutured close Fidelity will be maintained by providing specific training to 2-3 surgeons and only allowing them to perform the intervention for involvement in the study.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used) (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

All

Age

18 Years to 55 Years

Healthy volunteers

Inclusion criteria

Pregnant awaiting elective Lower Uterine caesarean Section (LUCS) delivery via the Pfannenstiel incision, under Neuraxial Blockade (NAB)

Exclusion criteria

Non- elective Lower Uterine caesarean Section (LUCS) patients as obtaining informed consent and accurate follow up and would be problematic. Those with a ASA status of 3 or greater have been excluded as they are likely to require a more flexible and a less protocolised anaesthetic and analgesic management for their treatment regime. Opiate tolerance – defined as those patients already on opiate medication or those with a history of opiate addiction Perioperative medications that differ or are expected to differ from the study protocol Those who receive a regional anaesthetic at the discretion of their treating anaesthetist that differs from the study protocol or obstetrician who considers or requests a uterotonic agent that differs from the study protocol postoperative analgesia regimen unable to tolerate NSAIDS, Paracetamol or endone/ Targin Failure of the NAB Bleeding diathesis ( e.g. vWF ): at risk of haematoma at injection or operative site Allergy to study medications specifically: amide Local anaesthetic agents Inability to independently understand the nature of the consent or not be able to respond appropriately and independently to the post operative data collection. Peri-operative complications Post Partum Haemorrhage/Uterine atony requiring further medical or surgical intervention: postoperative drain(s) required The participant withdraws or declines to participate in this study

Outcome results