TAP and IMS for HIPEC

Phase 3

Completed

• Conditions: Cytoreductive Surgery
• Interventions: Procedure: IVPCA; Procedure: TAP; Procedure: IMS

• Registration Number: NCT04981639
• Lead Sponsor: Gangnam Severance Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-07-25
• Study First Submitted QC: 2021-07-28
• Study First Posted: 2021-07-29
• Study Start: 2021-08-21
• Primary Completion: 2022-06-14
• Study Completion: 2022-06-14
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-06
• Last Update Posted: 2022-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 81

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I (IVPCA)	IVPCA	Intravenous patient controlled analgesia will be performed.
II (IVPCA+TAP)	TAP	Intravenous patient controlled analgesia and transversus abdominis plane block will be performed.
III (IVPCA, IMS, and TAP)	IMS	Intravenous patient controlled analgesia, transversus abdominis plane block, and intramuscular muscular stimulation will be performed.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pain score	At postoperative day 2, 3, 5, 7, 14 and 28	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.
IVPCA consumption	At postoperative day 1, 2, and 3	Intravenous patient controlled analgesia consumption will be measured at postoperative day 0, 1, 2, and 3.
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	Peak cough flow will be evaluated at postoperative day -1, 4, 7, 14, and 28.
Gait speed	day -1, 4, 7, 14, and 28	Gait speed will be evaluated at postoperative day -1, 4, 7, 14, and 28.
Quality of life will be evaluated using QoR40 questionnaire (0-200)	At postoperative day 4 and 7	Quality of life will be evaluated using QoR40 questionnaire (0-200) at postoperative day 4 and 7.
Nausea will be evaluated using 2 point scale (yes, no)	At postoperative day 1, 2, 3, 5 and 7	Nausea will be evaluated using 2 point scale (yes, no) at postoperative day 1, 2, 3, 5 and 7.

Trial Locations

Locations (1)

GangnamSeveranceHospital; 🇰🇷 Seoul, Korea, Republic of