Cytoreductive SurgeryPhase 3NCT04981639
TAP and IMS for HIPEC
A Phase 3 study testing IVPCA, TAP and IMS in people with Cytoreductive Surgery, run by Gangnam Severance Hospital at 1 site in South Korea.
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Cytoreductive Surgery
- What is being tested?
- IVPCA, TAP and IMS
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Aug 2021to 14 Jun 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -Patients who are able to do daily activity and walk independently.
Who cannot join
- 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
Show all 9Show fewer
- Patients with history of substance abuse
- Pregnancy
- Patients who are unable to communicate due to mental disorder
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Cytoreductive Surgery
- Being tested
- IVPCA, TAP, IMS
- Keywords
- hyperthermic intra-peritoneal chemotherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IVPCAProcedure or surgery
Intravenous patient controlled analgesia will be performed.
TAPProcedure or surgery
Transversus abdominis plane block will be performed.
IMSProcedure or surgery
Intramuscular electrical stimulation will be performed.
| Study group | Role | What they receive |
|---|---|---|
| I (IVPCA) | Active comparator | Intravenous patient controlled analgesia will be performed. Receives: Procedure: IVPCA |
| II (IVPCA+TAP) | Active comparator | Intravenous patient controlled analgesia and transversus abdominis plane block will be performed. Receives: Procedure: TAP |
| III (IVPCA, IMS, and TAP) | Active comparator | Intravenous patient controlled analgesia, transversus abdominis plane block, and intramuscular muscular stimulation will be performed. Receives: Procedure: IMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Pain score will be measured using visual analogue scale (0: no pain, 10: worst imaginable pain) at postoperative day 1.
Measured: At postoperative day 1
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: At postoperative day 1, 2, 3, 5 and 7
Vomiting will be evaluated using 2 point scale (yes, no)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: At postoperative day 4 and 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2021
- Study start21 Aug 2021
- Primary completion14 Jun 2022
- Study completion14 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cytoreductive SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Young Song, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981639
- Sponsor's protocol ID
- 3-2021-0032
- Status last verified
- Oct 2022
- First submitted
- 25 Jul 2021
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim HC, Park J, Oh J, Kim M, Park EJ, Baik SH, Song Y. Analgesic effects of combined transversus abdominis plane block and intramuscular electrical stimulation in patients undergoing cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy: a randomized controlled trial. Int J Surg. 2023 May 1;109(5):1199-1207. doi: 10.1097/JS9.0000000000000383.
PubMed 36999805
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04981639
- Acronym / sponsor ID
- 3-2021-0032
- Conditions
- Cytoreductive Surgery
- Keywords
- hyperthermic intra-peritoneal chemotherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 21 Aug 2021 (actual)
- Primary completion
- 14 Jun 2022 (actual)
- Study completion
- 14 Jun 2022 (actual)
- First posted
- 29 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| I (IVPCA) | Active comparator | Procedure: IVPCAIntravenous patient controlled analgesia will be performed. |
| II (IVPCA+TAP) | Active comparator | Procedure: TAPIntravenous patient controlled analgesia and transversus abdominis plane block will be performed. |
| III (IVPCA, IMS, and TAP) | Active comparator | Procedure: IMSIntravenous patient controlled analgesia, transversus abdominis plane block, and intramuscular muscular stimulation will be performed. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -Patients who are able to do daily activity and walk independently.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IVPCAIntravenous patient controlled analgesia will be performed. | Procedure or surgery | I (IVPCA) |
| TAPTransversus abdominis plane block will be performed. | Procedure or surgery | II (IVPCA+TAP) |
| IMSIntramuscular electrical stimulation will be performed. | Procedure or surgery | III (IVPCA, IMS, and TAP) |
Primary outcome
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.
7 secondary outcomes
Pain score
Time frame: At postoperative day 2, 3, 5, 7, 14 and 28
IVPCA consumption
Time frame: At postoperative day 1, 2, and 3
Nausea will be evaluated using 2 point scale (yes, no)
Time frame: At postoperative day 1, 2, 3, 5 and 7
Vomiting will be evaluated using 2 point scale (yes, no)
Time frame: at postoperative day 1, 2, 3, 5 and 7.
Peak cough flow
Time frame: At postoperative day -1, 4, 7, 14, and 28
Gait speed
Time frame: day -1, 4, 7, 14, and 28
Quality of life will be evaluated using QoR40 questionnaire (0-200)
Time frame: At postoperative day 4 and 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
- Derived from this study: PubMed 36999805Kim HC, Park J, Oh J, Kim M, Park EJ, Baik SH, Song Y. Analgesic effects of combined transversus abdominis plane block and intramuscular electrical stimulation in patients undergoing cytoreductive surgery followed by hyperthermic intraperitoneal chemotherapy: a randomized controlled trial. Int J Surg. 2023 May 1;109(5):1199-1207. doi: 10.1097/JS9.0000000000000383.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing IVPCA, TAP and IMS in people with Cytoreductive Surgery, run by Gangnam Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: At postoperative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04981639, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2022; AzTrials last refreshed its copy on 1 Nov 2026.