TAP and IMS for HIPEC

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

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 Overview

• Status: Completed
• Conditions: Cytoreductive Surgery
• Intervention / Treatment: Procedure: IVPCA; Procedure: TAP; Procedure: IMS

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Phase 3

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • GangnamSeveranceHospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: I (IVPCA); Intravenous patient controlled analgesia will be performed.	Procedure: IVPCA; Intravenous patient controlled analgesia will be performed.
Active Comparator: II (IVPCA+TAP); Intravenous patient controlled analgesia and transversus abdominis plane block will be performed.	Procedure: TAP; Transversus abdominis plane block will be performed.
Active Comparator: III (IVPCA, IMS, and TAP); Intravenous patient controlled analgesia, transversus abdominis plane block, and intramuscular muscular stimulation will be performed.	Procedure: IMS; Intramuscular electrical stimulation will be performed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Vomiting will be evaluated using 2 point scale (yes, no)		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.	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.	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.	At postoperative day 4 and 7

Collaborators and Investigators

• Sponsor: Gangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2021
• Primary Completion (Actual): June 14, 2022
• Study Completion (Actual): June 14, 2022

Study Registration Dates

• First Submitted: July 25, 2021
• First Submitted That Met QC Criteria: July 28, 2021
• First Posted (Actual): July 29, 2021

Study Record Updates

• Last Update Posted (Actual): October 10, 2022
• Last Update Submitted That Met QC Criteria: October 6, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: hyperthermic intra-peritoneal chemotherapy
• Other Study ID Numbers: 3-2021-0032

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No