TAP and IMS for HIPEC

Cytoreductive Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04981639
• Other study ID #: 3-2021-0032
• Status: Completed
• Phase: Phase 3
• Start date: August 21, 2021
• Est. completion date: June 14, 2022

Study information

• Verified date: October 2022
• Source: Gangnam Severance Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: June 14, 2022
• Est. primary completion date: June 14, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cytoreductive Surgery

Intervention

Procedure:
• IVPCA
Intravenous patient controlled analgesia will be performed.
• TAP
Transversus abdominis plane block will be performed.
• IMS
Intramuscular electrical stimulation will be performed.

Locations

Country	Name	City	State
Korea, Republic of	GangnamSeveranceHospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Gangnam Severance Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Vomiting will be evaluated using 2 point scale (yes, no)		at postoperative day 1, 2, 3, 5 and 7.
Secondary	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
Secondary	Gait speed	Gait speed will be evaluated at postoperative day -1, 4, 7, 14, and 28.	day -1, 4, 7, 14, and 28
Secondary	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