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Completed

NCT Number: NCT04981639

TAP and IMS for HIPEC

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.

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Key information

Conditions

Cytoreductive Surgery

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

GangnamSeveranceHospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

IVPCA

Procedure

Intravenous patient controlled analgesia will be performed.

TAP

Procedure

Transversus abdominis plane block will be performed.

IMS

Procedure

Intramuscular electrical stimulation will be performed.

Primary outcomes

  1. Pain score

    Time frame: 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 outcomes

  1. Pain score

    Time frame: 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.

  2. IVPCA consumption

    Time frame: At postoperative day 1, 2, and 3

    Intravenous patient controlled analgesia consumption will be measured at postoperative day 0, 1, 2, and 3.

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

    Time frame: 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.

  4. Vomiting will be evaluated using 2 point scale (yes, no)

    Time frame: at postoperative day 1, 2, 3, 5 and 7.

  5. Peak cough flow

    Time frame: At postoperative day -1, 4, 7, 14, and 28

    Peak cough flow will be evaluated at postoperative day -1, 4, 7, 14, and 28.

  6. Gait speed

    Time frame: day -1, 4, 7, 14, and 28

    Gait speed will be evaluated at postoperative day -1, 4, 7, 14, and 28.

  7. Quality of life will be evaluated using QoR40 questionnaire (0-200)

    Time frame: At postoperative day 4 and 7

    Quality of life will be evaluated using QoR40 questionnaire (0-200) at postoperative day 4 and 7.

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 29, 2021
Registry last updated
Oct 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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