TAP and IMS for HIPEC

NCT04981639 | Completed Phase 3

• 1 other identifier: 3-2021-0032
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cytoreductive Surgery

Keywords

hyperthermic intra-peritoneal chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Pain score

  At postoperative day 2, 3, 5, 7, 14 and 28

• IVPCA consumption

  At postoperative day 1, 2, and 3

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

  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

  At postoperative day -1, 4, 7, 14, and 28

Study Arms (3)

I (IVPCA)

ACTIVE COMPARATOR

Intravenous patient controlled analgesia will be performed.

Procedure: IVPCA

II (IVPCA+TAP)

ACTIVE COMPARATOR

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

Procedure: TAP

III (IVPCA, IMS, and TAP)

ACTIVE COMPARATOR

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

Procedure: IMS

Interventions

IVPCA PROCEDURE

Intravenous patient controlled analgesia will be performed.

I (IVPCA)

TAP PROCEDURE

Transversus abdominis plane block will be performed.

II (IVPCA+TAP)

IMS PROCEDURE

Intramuscular electrical stimulation will be performed.

III (IVPCA, IMS, and TAP)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are able to do daily activity and walk independently.

You may not qualify if:

• 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

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

GangnamSeveranceHospital

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 36999805 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 25, 2021
• First Posted: July 29, 2021
• Study Start: August 21, 2021
• Primary Completion: June 14, 2022
• Study Completion: June 14, 2022
• Last Updated: October 10, 2022

Record last verified: 2022-10

Locations

KR (1)