The analgesic effectiveness of an Ilioinguinal-Transversus Abdominis Plane (iTAP) injection technique nerve block in addition to opioid plus NSAID analgesia for elective Caesarean Sections.

The efficacy of an Ilioinguinal-Transversus Abdominis Plane (iTAP) injection technique nerve block in addition to opioid plus NSAID post-operative analgesia for elective Caesarean Sections under spinal anaesthetic block with intrathecal morphine in reducing the opioid usage in the first 24 hours post-operatively compared to opioid plus NSAID post-operative analgesia alone.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12615001123538

Acronym

iTAPIT

Enrollment

100

Registered

2015-10-26

Start date

2016-02-04

Completion date

2016-06-29

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

PURPOSE One of the methods of providing pain relief after a Caesarean Section involves the injection of local anaesthetic into the muscle layers to surround the nerves that supply pain sensation to the lower abdomen. These blocks are called Ilioinguinal / Iliohypogastric nerve blocks and Transversus Abdominis Plane (TAP) blocks and have been used for a range of surgeries. This helps to reduce pain over the surgical wound where the Caesarean Section is performed. The purpose of this study is to determine if combining these blocks in addition to opioid and anti-inflammatory pain management will improve pain relief in the first 24 hours for women who have an elective Caesarean Section. This block will be performed at the end of the Caesarean section before the spinal anaesthetic has worn off. HYPOTHESIS Our primary aim is to determine whether administering the modified Ilioinguinal-Transversus Abdominis Plane (iTAP) nerve block in addition to opioid plus NSAID analgesia is superior to opioid plus NSAID analgesia alone following caesarean section with a Pfannenstiel incision. STUDY DESIGN AND INTERVENTION Approximately 100 volunteers will participate in this study and the study will be conducted at the Lyell McEwin Hospital. You will be enrolled in this study on the day of your Caesarean Section and randomly allocated to one of two groups. One group will receive pain medication with the iTAP block in the Post Anaesthetic Recovery Unit (PARU) as well as opioid medication (Fentanyl) through a Patient Controlled Analgesia (PCA) device. The second group will receive pain medication with the PCA but will receive a placebo block. A placebo is a medication with no active ingredients or a procedure without any medical benefit. It will feel like the real thing but it is not. Your participation in the study will continue until 24 hours after the iTAP block / placebo block. OUTCOMES We will be measuring total pain medication usage (opioids) and pain levels (VAS) over a 24 hour period. We will also measure adverse side effects of pain medication and the block, as well as the satisfaction of our participants. Hopefully there will be less pain and pain medication usage in our interventional group.

Interventions

A single shot bilateral iTAP nerve block using total of 60mls of 0.33% (i.e. 200mg) ropivacaine post-caesarean section in the Post-Operative Recovery Unit (PARU) before spinal anaesthetic has worn off iTAP - TECHNIQUE Single shot nerve block which combines a traditional TAP block and a traditional ilioinguinal-iliohypogastric nerve block. Landmarks: 2cm medial and superior to the ASIS. Sonoplex short bevel needle inserted perpendicular to skin until "1st pop" is felt and 10mls ropivacaine inje

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 50 Years

Healthy volunteers

Yes

Inclusion criteria

Competent to sign consent Elective Caesarean Section

Exclusion criteria

Emergency surgery Age < 18 years < 65kg Inability to consent, lack of written consent or speak English fluently Contraindication to spinal anaesthetic or block Allergy to local anaesthetics or morphine Pre-operative chronic opioid use or chronic pain syndrome Progressive neurological disease Patients in EREC (enhanced recovery after elective Caesarean Section) protocol

Outcome results