Cytoreductive Surgery Clinical Trial
Official title:
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
Verified date | October 2022 |
Source | Gangnam Severance Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 81 |
Est. completion date | June 14, 2022 |
Est. primary completion date | June 14, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility | Inclusion Criteria: -Patients who are able to do daily activity and walk independently. Exclusion Criteria: 1. Patients with history of preoperative abdominal surgery 2. Patients who are unable to walk independently due to musculoskeletal disorder 3. Patients who are allergic to local anesthetics 4. Patients with chronic pain 5. Patients with pacemaker 6. Patients with endotracheal tube postoperatively 7. Patients with history of substance abuse 8. Pregnancy 9. Patients who are unable to communicate due to mental disorder |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | GangnamSeveranceHospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Gangnam Severance Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Vomiting will be evaluated using 2 point scale (yes, no) | at postoperative day 1, 2, 3, 5 and 7. | ||
Secondary | 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 | |
Secondary | Gait speed | Gait speed will be evaluated at postoperative day -1, 4, 7, 14, and 28. | day -1, 4, 7, 14, and 28 | |
Secondary | 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 |
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