TAP and IMS for HIPEC

Yonsei University Health System (YUHS)

Status and phase: Completed; Phase 3

Conditions: Cytoreductive Surgery

Treatments: Procedure: IVPCA; Procedure: TAP; Procedure: IMS

Study type: Interventional

Funder types: Other

Identifiers

NCT04981639

3-2021-0032

Details and patient eligibility

About

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.

Enrollment: 81 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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81 participants in 3 patient groups

I (IVPCA)

Active Comparator group

Description:

Intravenous patient controlled analgesia will be performed.

Treatment:

Procedure: IVPCA

II (IVPCA+TAP)

Active Comparator group

Description:

Intravenous patient controlled analgesia and transversus abdominis plane block will be performed.

Treatment:

Procedure: TAP

III (IVPCA, IMS, and TAP)

Active Comparator group

Description:

Intravenous patient controlled analgesia, transversus abdominis plane block, and intramuscular muscular stimulation will be performed.

Treatment:

Procedure: IMS