TAP and IMS for HIPEC

Gangnam Severance Hospital81 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Cytoreductive Surgery

Interventions

IVPCAPROCEDURE

Intravenous patient controlled analgesia will be performed.

TAPPROCEDURE

Transversus abdominis plane block will be performed.

IMSPROCEDURE

Intramuscular electrical stimulation will be performed.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

GangnamSeveranceHospital

Seoul, South Korea

Outcomes

Primary Outcomes

Pain score

Pain score will be measured using visual analogue scale (0: no pain, 10: worst imaginable pain) at postoperative day 1.

Time frame: At postoperative day 1

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: At postoperative day 1, 2, 3, 5 and 7

Vomiting will be evaluated using 2 point scale (yes, no)

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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