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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04981639

Enrollment

Registered

2021-07-29

Start date

2021-08-21

Completion date

2022-06-14

Last updated

2022-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cytoreductive Surgery

Keywords

hyperthermic intra-peritoneal chemotherapy

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.

Interventions

PROCEDUREIVPCA

Intravenous patient controlled analgesia will be performed.

PROCEDURETAP

Transversus abdominis plane block will be performed.

PROCEDUREIMS

Intramuscular electrical stimulation will be performed.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
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.
Vomiting will be evaluated using 2 point scale (yes, no)	at postoperative day 1, 2, 3, 5 and 7.	—
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.
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.
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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026