TAP and IMS for HIPEC

Study Overview
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Brief Summary
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It is important to decrease the postoperative pain in patients undergoing cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy. We will compare the Transversus abdominis plane block with the Transversus abdominis plane block plus intramuscular electrical stimulation in patients undergoing cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy.

Official Title
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Effects of Transabdominal Plane Block and Electrical Twitch Obtaining Intramuscular Stimulation on the Postoperative Pain in Cytoreductive Surgery and Hyperthermic Intra-peritoneal Chemotherapy (CRS and HIPEC): a Double-blind Randomized Control Trial

Conditions
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Cytoreductive Surgery

Intervention / Treatment
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* Procedure: IVPCA
* Procedure: TAP
* Procedure: IMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: -Patients who are able to do daily activity and walk independently. Exclusion Criteria: Patients with history of preoperative abdominal surgery Patients who are unable to walk independently due to musculoskeletal disorder Patients who are allergic to local anesthetics Patients with chronic pain Patients with pacemaker Patients with endotracheal tube postoperatively Patients with history of substance abuse Pregnancy Patients who are unable to communicate due to mental disorder

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: I (IVPCA)<br>Intravenous patient controlled analgesia will be performed. | Procedure: IVPCA<br>* Intravenous patient controlled analgesia will be performed.<br>|
| Active Comparator: II (IVPCA+TAP)<br>Intravenous patient controlled analgesia and transversus abdominis plane block will be performed. | Procedure: TAP<br>* Transversus abdominis plane block will be performed.<br>|
| Active Comparator: III (IVPCA, IMS, and TAP)<br>Intravenous patient controlled analgesia, transversus abdominis plane block, and intramuscular muscular stimulation will be performed. | Procedure: IMS<br>* Intramuscular electrical stimulation will be performed.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Pain score will be measured using visual analogue scale (0: no pain, 10: worst imaginable pain) at postoperative day 1. | At postoperative day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | Pain score will be measured using visual analogue scale (0: no pain, 10: worst imaginable pain) at postoperative day 0, 2, 3, 5, 7, 14 and 28. | At postoperative day 2, 3, 5, 7, 14 and 28 | 
| IVPCA consumption | Intravenous patient controlled analgesia consumption will be measured at postoperative day 0, 1, 2, and 3. | At postoperative day 1, 2, and 3 | 
| Nausea will be evaluated using 2 point scale (yes, no) | Nausea will be evaluated using 2 point scale (yes, no) at postoperative day 1, 2, 3, 5 and 7. | At postoperative day 1, 2, 3, 5 and 7 | 
| Vomiting will be evaluated using 2 point scale (yes, no) |  | at postoperative day 1, 2, 3, 5 and 7. | 
| Peak cough flow | Peak cough flow will be evaluated at postoperative day -1, 4, 7, 14, and 28. | At postoperative day -1, 4, 7, 14, and 28 | 
| Gait speed | Gait speed will be evaluated at postoperative day -1, 4, 7, 14, and 28. | day -1, 4, 7, 14, and 28 | 
| Quality of life will be evaluated using QoR40 questionnaire (0-200) | Quality of life will be evaluated using QoR40 questionnaire (0-200) at postoperative day 4 and 7. | At postoperative day 4 and 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hyperthermic intra-peritoneal chemotherapy