TAP and IMS for HIPEC

NCT ID: NCT04981639

Last Updated: 2022-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-21

Study Completion Date

2022-06-14

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.

Detailed Description

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Conditions

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Cytoreductive Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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I (IVPCA)

Intravenous patient controlled analgesia will be performed.

Group Type ACTIVE_COMPARATOR

IVPCA

Intervention Type PROCEDURE

Intravenous patient controlled analgesia will be performed.

II (IVPCA+TAP)

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

Group Type ACTIVE_COMPARATOR

TAP

Intervention Type PROCEDURE

Transversus abdominis plane block will be performed.

III (IVPCA, IMS, and TAP)

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

Group Type ACTIVE_COMPARATOR

IMS

Intervention Type PROCEDURE

Intramuscular electrical stimulation will be performed.

Interventions

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IVPCA

Intravenous patient controlled analgesia will be performed.

Intervention Type PROCEDURE

TAP

Transversus abdominis plane block will be performed.

Intervention Type PROCEDURE

IMS

Intramuscular electrical stimulation will be performed.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gangnam Severance Hospital

OTHER

Sponsor Role lead

Responsible Party

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Young Song

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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GangnamSeveranceHospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Kim HC, Park J, Oh J, Kim M, Park EJ, Baik SH, Song Y. Analgesic effects of combined transversus abdominis plane block and intramuscular electrical stimulation in patients undergoing cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy: a randomized controlled trial. Int J Surg. 2023 May 1;109(5):1199-1207. doi: 10.1097/JS9.0000000000000383.

Reference Type DERIVED
PMID: 36999805 (View on PubMed)

Other Identifiers

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3-2021-0032

Identifier Type: -

Identifier Source: org_study_id

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