Postoperative Pain, AcuteTAPNCT05222789
Postoperative Pain in Patients Undergoing Scheduled Laparoscopic Intestinal Resection Surgery
An observational study of Postoperative Pain, Acute and Postoperative Pain, Chronic, run by Hospital Universitario de Gran Canaria Doctor Negrín at 1 site in Spain.
Trial summary
This observational prospective study aims to evaluate the postoperative analgesic effect of a regional anesthesia thechnique (TAP block) in patients undergoing scheduled laparoscopic intestinal resection for intestinal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain, Acute, Postoperative Pain, Chronic
- What is being tested?
- TAP
- Type of treatment
- Surgery or procedure
- How many people
- 105 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2019to 20 Mar 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is an observational prospective study comparing routine practice of analgesic management in consecutive surgical patients scheduled to undergo elective intestinal laparoscopic resection for suffering from intestinal cancer. 60 patients are expected to be included in this study and perioperative analgesic management prewarming will be performed following routine clinical practice. TAP block will be performed peroperatively under ultrasound control according to the anesthesiologist's decision. The patients will be followed up during the hospital stay (approximately one week) to evaluate the perioperative analgesic evolution and the appearance of secondary effects. A control will be carried out two years after surgery to evaluate the appearance of postoperative chronic pain.
Who may be able to join
- ASA I-III
- Operated on a scheduled basis for laparoscopic intestinal cancer resection
Who cannot join
- Under 18 years old
- Language barrier
- Cognitive impairment or inability to collaborate in clinical assessment during the study
- Drug or alcohol abuse
- Habitual intake of opioids
- Consumption of analgesics 24 hours before surgery
- BMI <18 or >35 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Pain Assessment in Patients Undergoing Scheduled Laparoscopic Intestinal Resection Surgery
This observational prospective study aims to evaluate the postoperative analgesic effect of a regional anesthesia thechnique (TAP block) in patients undergoing scheduled laparoscopic intestinal resection for intestinal cancer. ASA I-III patients operated between May 1 and September 30, 2019 under general anesthesia according to usual clinical practice, will be included. Patients who meet any of the following criteria will be excluded from this study: under 18 years old, language barrier, cognitive impairment or inability to assist in clinical assessment, drug or alcohol abuse, intake of opioids, consumption of analgesics 24 hours before surgery, BMI <18 or >35 kg/m2. Subsequently, an analysis will be made evaluating the quality of analgesia and the appearance of postoperative chronic pain and comparing the patients who underwent TAP block with those who did not.
Read the detailed description
The transverse abdominal plane (TAP) block is a regional anesthesia technique that blocks the afferent nerves of the anterolateral abdominal wall. This observational prospective study aims to evaluate the postoperative analgesic effect in patients undergoing laparoscopic intestinal resection. ASA I-III patients operated on a scheduled basis, between May 1 and September 30, 2019, by laparoscopy for intestinal cancer resection under general anesthesia according to usual clinical practice, will be included. Patients who meet any of the following criteria will be excluded from this study: under 18 years old, language barrier, cognitive impairment or inability to assist in clinical assessment, drug or alcohol abuse, intake of opioids, consumption of analgesics 24 hours before surgery, BMI <18 or >35 kg/m2. Subsequently, an analysis will be made evaluating the quality of analgesia and the appearance of postoperative chronic pain and comparing the patients who underwent TAP block with those who did not.
- Being tested
- TAP
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TAPProcedure or surgery
The transverse abdominal plane (TAP) block is a regional anesthesia technique performed using ultrasound that blocks the afferent nerves of the anterolateral abdominal wall, injecting local anesthetic in the fascial plane between the deep oblique and the transversus abdominis muscles.
| Study group | Role | What they receive |
|---|---|---|
| TAP block | Patients receiving TAP block preoperatively, following routine clinical practice Receives: Procedure: TAP | |
| Non-TAP | Patients not receiving TAP block preoperatively, following routine clinical practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative acute pain assessed using Visual Analogue Scale, from 0 to 10
assessed using visual analogue scale
Measured: from the arrival to the postanesthesia care unit to the 4 postoperative hours
Intraoperative analgesic consumption
assessed measuring the perioperative analgesics provided during the intraoperative period following routine clinical practice
Measured: from the anesthesia induction to the end of the surgery
Secondary outcomes (2)
Postoperative chronic pain assessed using Visual Analogue Scale, from 0 to 10
assessed using visual analogue scale
Measured: 2 years postoperatively
Side effects
to record the perioperative side effects secondary to the analgesia administered perioperatively
Measured: from the arrival to the postanesthesia care unit to the hospital discharge (7 days postoperatively)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start1 May 2019
- Primary completion20 Mar 2024
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain, AcuteStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor Negrín
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ángel Becerra, Hospital Universitario de Gran Canaria Doctor Negrín
- Investigators
- Ángel Becerra, Principal investigator, Hospital Universitario de Gran Canaria Doctor Negrín
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05222789
- Sponsor's protocol ID
- ARP-ANA-2015-01
- Acronym
- TAP
- Status last verified
- Oct 2024
- First submitted
- 24 Jan 2022
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain Assessment in Patients Undergoing Scheduled Laparoscopic Intestinal Resection Surgery
- ClinicalTrials.gov ID
- NCT05222789
- Acronym / sponsor ID
- TAP / ARP-ANA-2015-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Hospital Universitario de Gran Canaria Doctor NegrínUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 20 Mar 2024 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 3 Feb 2022 (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.
This observational prospective study aims to evaluate the postoperative analgesic effect of a regional anesthesia thechnique (TAP block) in patients undergoing scheduled laparoscopic intestinal resection for intestinal cancer. ASA I-III patients operated between May 1 and September 30, 2019 under general anesthesia according to usual clinical practice, will be included. Patients who meet any of the following criteria will be excluded from this study: under 18 years old, language barrier, cognitive impairment or inability to assist in clinical assessment, drug or alcohol abuse, intake of opioids, consumption of analgesics 24 hours before surgery, BMI <18 or >35 kg/m2. Subsequently, an analysis will be made evaluating the quality of analgesia and the appearance of postoperative chronic pain and comparing the patients who underwent TAP block with those who did not.
Detailed description
The transverse abdominal plane (TAP) block is a regional anesthesia technique that blocks the afferent nerves of the anterolateral abdominal wall. This observational prospective study aims to evaluate the postoperative analgesic effect in patients undergoing laparoscopic intestinal resection. ASA I-III patients operated on a scheduled basis, between May 1 and September 30, 2019, by laparoscopy for intestinal cancer resection under general anesthesia according to usual clinical practice, will be included. Patients who meet any of the following criteria will be excluded from this study: under 18 years old, language barrier, cognitive impairment or inability to assist in clinical assessment, drug or alcohol abuse, intake of opioids, consumption of analgesics 24 hours before surgery, BMI <18 or >35 kg/m2. Subsequently, an analysis will be made evaluating the quality of analgesia and the appearance of postoperative chronic pain and comparing the patients who underwent TAP block with those who did not.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAP block | – | Procedure: TAPPatients receiving TAP block preoperatively, following routine clinical practice |
| Non-TAP | – | –Patients not receiving TAP block preoperatively, following routine clinical practice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is an observational prospective study comparing routine practice of analgesic management in consecutive surgical patients scheduled to undergo elective intestinal laparoscopic resection for suffering from intestinal cancer. 60 patients are expected to be included in this study and perioperative analgesic management prewarming will be performed following routine clinical practice. TAP block will be performed peroperatively under ultrasound control according to the anesthesiologist's decision. The patients will be followed up during the hospital stay (approximately one week) to evaluate the perioperative analgesic evolution and the appearance of secondary effects. A control will be carried out two years after surgery to evaluate the appearance of postoperative chronic pain.
Key inclusion criteria (2 listed)
- ASA I-III
- Operated on a scheduled basis for laparoscopic intestinal cancer resection
Key exclusion criteria (7 listed)
- Under 18 years old
- Language barrier
- Cognitive impairment or inability to collaborate in clinical assessment during the study
- Drug or alcohol abuse
- Habitual intake of opioids
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 |
|---|---|---|
| TAPThe transverse abdominal plane (TAP) block is a regional anesthesia technique performed using ultrasound that blocks the afferent nerves of the anterolateral abdominal wall, injecting local anesthetic in the fascial plane between the deep oblique and the transversus abdominis muscles. | Procedure or surgery | TAP block |
Primary outcome
Postoperative acute pain assessed using Visual Analogue Scale, from 0 to 10
Time frame: from the arrival to the postanesthesia care unit to the 4 postoperative hours
assessed using visual analogue scale
Intraoperative analgesic consumption
Time frame: from the anesthesia induction to the end of the surgery
assessed measuring the perioperative analgesics provided during the intraoperative period following routine clinical practice
2 secondary outcomes
Postoperative chronic pain assessed using Visual Analogue Scale, from 0 to 10
Time frame: 2 years postoperatively
Side effects
Time frame: from the arrival to the postanesthesia care unit to the hospital discharge (7 days postoperatively)
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 16 Oct 2024.
- Individual participant dataSharing planned: Undecided
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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.
Ángel Becerra principal investigator
Hospital Universitario de Gran Canaria Doctor Negrín
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Pain, Acute and Postoperative Pain, Chronic, run by Hospital Universitario de Gran Canaria Doctor Negrín at 1 site in Spain.
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 2 inclusion and 7 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 16 Oct 2024. 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 Spain. 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.
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?
Postoperative acute pain assessed using Visual Analogue Scale, from 0 to 10 (time frame: from the arrival to the postanesthesia care unit to the 4 postoperative hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2024.