Comparison of Intrathecal Morphine With the Quadratus Lumborum Type 2 Block for Post-operative Analgesia Following Elective Caesarean Section (QLBvITM Study)
Quadratus Lumborum Type 2 Block Versus Intrathecal Morphine for Analgesia Following Elective Caesarean Sections
調査の概要
状態
詳細な説明
In Australia the rate of birth via caesarean section (CS) has significantly increased over the last twenty years. Improvements in the care of women undergoing CS are important locally, nationally and internationally. Compared to women birthing vaginally, women undergoing CS experience more adverse events and more pain. Effective pain relief following CS is important as it enables early ambulation, encourages maternal bonding, and promotes breastfeeding initiation and establishment. Traditional analgesic techniques following CS include opioid medications. Whist effective, the use of opioids are associated with frequent and significant side effects. Alternative analgesic agents are being explored in an attempt to improve the effectiveness of pain relief available to women and clinicians.
The quadratus lumborum block (QLB) block is an innovative regional analgesic technique. Its role as an effective analgesic agent in abdominal surgery is increasing. However, it has not been studied for pain relief in Australia after cesarean section.
In this study, the investigator aims to compare post-operative analgesia and side effects between the QLB blocks versus adding morphine the participant's spinal anaesthetic (ITM) during the elective C/S. Results from this study will provide information on the analgesic impact of this new and emerging therapy and assist in the development of a larger clinical trial.
研究の種類
段階
- 適用できない
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Anaesthetist trained in QLB and ITM techniques available
- American Society of Anaesthesiologists PS category client I or II
- 18 years of age or older
- Ability to read and understand English
- Uncomplicated pregnancy at term (>37 weeks completed gestation)
- Booked elective CS
Exclusion Criteria:
- Contraindications to spinal anaesthesia
- History of chronic opioid consumption / chronic pain conditions
- Known allergy to study drugs
- Weight more than 95kg or body mass index (BMI) more than 35 pre operative
- Placenta Previa / accreta
- Obstructive Sleep apnoea
- Severe asthma unable to tolerate Non steroidal anti inflammatory agents
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
偽コンパレータ：Saline intrathecal as well as saline in Blocks
These 25 patients will receive 0.3ml saline added to the spinal anaesthetic and 25 ml saline both sides as a QLB2.
|
0.3 ml saline will be added to the spinal anaesthetic.
25 ml saline will be used on each side during a quadratus lumborum type 2 block.
0.3 ml saline will be added to the spinal anaesthetic.
A Quadratus lumborum type 2 block will be performed under ultrasound with 25 ml 0.375% ropivacaine deposited posterior to the quadratus lumborum muscle.
|
|
アクティブコンパレータ：Saline intrathecal as well as local anaesthetic in Blocks
These 25 patients will receive 0.3ml saline added to the spinal anaesthetic and 25 ml local anaesthetic both sides as a QLB2.
|
0.3 ml saline will be added to the spinal anaesthetic.
25 ml saline will be used on each side during a quadratus lumborum type 2 block.
A Quadratus lumborum type 2 block will be performed under ultrasound with 25 ml 0.375% ropivacaine deposited posterior to the quadratus lumborum muscle.
150mcg morphine will be added to the spinal anaesthetic.
|
|
アクティブコンパレータ：Intrathecal morphine as well as local anaesthetic in Blocks
These 25 patients will receive 0.3ml (150mcg) morphine added to the spinal anaesthetic and 25 ml local anaesthetic both sides as a QLB2.
|
A Quadratus lumborum type 2 block will be performed under ultrasound with 25 ml 0.375% ropivacaine deposited posterior to the quadratus lumborum muscle.
150mcg morphine will be added to the spinal anaesthetic.
150mcg morphine will be added to the spinal anaesthetic.
25 ml saline will be used on each side during a quadratus lumborum type 2 block.
|
|
アクティブコンパレータ：Intrathecal morphine as well as saline in Block
These 25 patients will receive 0.3ml (150mcg) morphine added to the spinal anaesthetic and 25 ml saline both sides as a QLB2.
|
0.3 ml saline will be added to the spinal anaesthetic.
A Quadratus lumborum type 2 block will be performed under ultrasound with 25 ml 0.375% ropivacaine deposited posterior to the quadratus lumborum muscle.
150mcg morphine will be added to the spinal anaesthetic.
25 ml saline will be used on each side during a quadratus lumborum type 2 block.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
24 hours total intravenous morphine usage via a PCA pump
時間枠：24 hours
|
Post operative intravenous morphine use will be noted at 24 hours post cesarean section
|
24 hours
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient's side effects within the 24 hours post operative period.
時間枠：24 hours
|
Nausea, vomiting, itching, herpes reactivation, urinary retention and sedation will be noted.
|
24 hours
|
|
Pain Scores within 24 hours post operative period.
時間枠：24 hours
|
Using a VAS we will note both dynamic and static pain scores at 24 hours post operative
|
24 hours
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Willem Basson, FANZCA、Sunshine Coast University Hospital
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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