Postoperative PainTAPNCT02029755
Transversus Abdominis Plane Block Versus Local Anesthetic Infiltration for Pain Control in the Abdominal Surgery
A study testing transversus abdominis plane block and local infiltration in people with Postoperative Pain, run by Taipei Medical University Hospital at 1 site in Taiwan.
Trial summary
Postoperative analgesia is an important part of the anesthetic care. According to the recent studies, multimodal analgesia can provide better analgesia \& patient satisfaction with fewer side effect. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- transversus abdominis plane block and local infiltration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2013to Jun 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (20~65y/o)
- American Society of Anesthesiologists (ASA) physical status I~II
- Patients scheduled for regular abdominal surgery under general anesthesia
Who cannot join
- ASA physical status ≥ 3
- Allergy to morphine or local anesthetics
- Morphine tolerance
- Drug abuse or addiction
- Bleeding tendency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound-guided-transversus Abdominis Plane(TAP) Block Versus Local Anesthetic(LA) Infiltration-the Effectiveness of Post-operative Pain Control in the Abdominal Surgery
Postoperative analgesia is an important part of the anesthetic care. According to the recent studies, multimodal analgesia can provide better analgesia \& patient satisfaction with fewer side effect. For example, combining intravenous, intramuscular or oral analgesics with transversus abdominis plane (TAP) block or local anesthetic (LA) infiltration as the multimodal analgesia, can furnish a more effective pain control after the abdominal surgery.
For abdominal surgery, both local infiltration and TAP block target on relieving somatic pain. Local anesthetic wound infiltration is easy to perform with low risk. As the advancement of ultrasound technology, performing the TAP block also becomes easier, safer and more accurate. But whether LA infiltration or TAP block is better for the multimodal analgesia regimen remains unclear.
This study is to compare the postoperative pain score, opioid consumption, side effects, and quality of recovery between these two analgesic methods in patients undergoing abdominal surgery. The investigators hypothesized that TAP block may be more effective than LA infiltration as a part of the multimodal analgesia, and can improve the recovery after the abdominal surgery.
- Conditions
- Postoperative Pain
- Being tested
- transversus abdominis plane block, local infiltration, Patient controlled analgesia
- Keywords
- transversus abdominis plane block, local infiltration, ropivacaine, heart rate variability, postoperative analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transversus abdominis plane blockProcedure or surgery
bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia
local infiltrationProcedure or surgery
Also called local anesthetics infiltration
local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure
Patient controlled analgesiaProcedure or surgery
postoperative analgesia with intravenous patient controlled analgesia with morphine
| Study group | Role | What they receive |
|---|---|---|
| TAP block | Experimental | postoperative analgesia with sono-guided transversus abdominis plane block and intravenous patient controlled analgesia (IV-PCA). Bilateral sono-guided TAP block will be performed after the induction of general anesthesia. 20 ml of 0.25% ropivacaine will be injected to the transversus abdominis plane under ultrasound guidance at each side (total 40 ml). IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery. Receives: Procedure: transversus abdominis plane block; Procedure: Patient controlled analgesia |
| Local infiltration | Active comparator | postoperative analgesia with local anesthetics infiltration at surgical wound and intravenous patient controlled analgesia (IV-PCA). 20 ml of 0.5% ropivacaine will be injected at the surgical wound by the surgeon before the closure of wound. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery. Receives: Procedure: local infiltration; Procedure: Patient controlled analgesia |
| PCA only | Active comparator | postoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery. Receives: Procedure: Patient controlled analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Score (NRS: Numerical Rating Scale)
pain scores of the participants will be followed at postoperative 1, 6, 24, 48 hour (up to 48 hours).
(NRS: from 0 to 10, 0 = no pain, 10 = the worst pain) The higher score idicates the worse outcome.
Measured: postoperative 24 hour dynamic
Opioid Consumption
opioid consumption of the participants will be followed at postoperative 1, 6, 12, 24, 36, 48 hour (up to 48 hours).
Measured: postoperative 48 hour
Secondary outcomes (11)
Sedation Scale
Measured: postoperative 1, 6, 24, 48 hour
Nausea and Vomiting Categorical Score
Measured: postoperative 1, 6, 24, 48 hour
Rescue Analgesic Use
Measured: postoperative 1, 6, 12, 24, 36, 48 hour
Rescue Antiemetics Use
Measured: postoperative 1, 6, 12, 24, 36, 48 hour
Time to the First Request of Analgesics
participants will be followed for the duration of hospital stay
Measured: an expected average of 5 days
Pruritus
Measured: postoperative 1, 6, 24, 48 hour
Quality of Recovery 40
Measured: postoperative 48 hour
Heart Rate Variability
Measured: preoperative, postoperative 1 hour and 1 day
Time to Flatus
participants will be followed for the duration of hospital stay
Measured: an expected average of 5 days
Length of Hospital Stay
participants will be followed for the duration of hospital stay
Measured: an expected average of 5 days
Number of Participants With Intervention-related Complication
participants will be followed for the duration of hospital stay
Measured: an expected average of 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionApr 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postoperative PainStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hsiao chien tsai, Taipei Medical University Hospital
- Investigators
- Chuen-Chau Chang, PhD, Principal investigator, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02029755
- Sponsor's protocol ID
- 201309028
- Acronym
- TAP
- Status last verified
- May 2015
- First submitted
- 5 Jan 2014
- Last updated
- 8 Jun 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided-transversus Abdominis Plane(TAP) Block Versus Local Anesthetic(LA) Infiltration-the Effectiveness of Post-operative Pain Control in the Abdominal Surgery
- ClinicalTrials.gov ID
- NCT02029755
- Acronym / sponsor ID
- TAP / 201309028
- Conditions
- Postoperative Pain
- Keywords
- transversus abdominis plane block, local infiltration, ropivacaine, heart rate variability, postoperative analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Taipei Medical University HospitalUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 8 Jan 2014 (estimated)
- Results
- Posted 8 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Postoperative analgesia is an important part of the anesthetic care. According to the recent studies, multimodal analgesia can provide better analgesia \& patient satisfaction with fewer side effect. For example, combining intravenous, intramuscular or oral analgesics with transversus abdominis plane (TAP) block or local anesthetic (LA) infiltration as the multimodal analgesia, can furnish a more effective pain control after the abdominal surgery.
For abdominal surgery, both local infiltration and TAP block target on relieving somatic pain. Local anesthetic wound infiltration is easy to perform with low risk. As the advancement of ultrasound technology, performing the TAP block also becomes easier, safer and more accurate. But whether LA infiltration or TAP block is better for the multimodal analgesia regimen remains unclear.
This study is to compare the postoperative pain score, opioid consumption, side effects, and quality of recovery between these two analgesic methods in patients undergoing abdominal surgery. The investigators hypothesized that TAP block may be more effective than LA infiltration as a part of the multimodal analgesia, and can improve the recovery after the abdominal surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TAP block | Experimental | Procedure: transversus abdominis plane block, Procedure: Patient controlled analgesiapostoperative analgesia with sono-guided transversus abdominis plane block and intravenous patient controlled analgesia (IV-PCA). Bilateral sono-guided TAP block will be performed after the induction of general anesthesia. 20 ml of 0.25% ropivacaine will be injected to the transversus abdominis plane under ultrasound guidance at each side (total 40 ml). IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery. |
| Local infiltration | Active comparator | Procedure: local infiltration, Procedure: Patient controlled analgesiapostoperative analgesia with local anesthetics infiltration at surgical wound and intravenous patient controlled analgesia (IV-PCA). 20 ml of 0.5% ropivacaine will be injected at the surgical wound by the surgeon before the closure of wound. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery. |
| PCA only | Active comparator | Procedure: Patient controlled analgesiapostoperative analgesia with intravenous patient controlled analgesia. IV-PCA with morphine will be ready for postoperative pain control at the end of the surgery. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult (20~65y/o)
- American Society of Anesthesiologists (ASA) physical status I~II
- Patients scheduled for regular abdominal surgery under general anesthesia
Key exclusion criteria (5 listed)
- ASA physical status ≥ 3
- Allergy to morphine or local anesthetics
- Morphine tolerance
- Drug abuse or addiction
- Bleeding tendency
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 |
|---|---|---|
| transversus abdominis plane blockbilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia | Procedure or surgery | TAP block |
| local infiltrationAlso: local anesthetics infiltrationlocal anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure | Procedure or surgery | Local infiltration |
| Patient controlled analgesiapostoperative analgesia with intravenous patient controlled analgesia with morphine | Procedure or surgery | Local infiltration, PCA only, TAP block |
Primary outcome
Pain Score (NRS: Numerical Rating Scale)
Time frame: postoperative 24 hour dynamic
pain scores of the participants will be followed at postoperative 1, 6, 24, 48 hour (up to 48 hours). (NRS: from 0 to 10, 0 = no pain, 10 = the worst pain) The higher score idicates the worse outcome.
Opioid Consumption
Time frame: postoperative 48 hour
opioid consumption of the participants will be followed at postoperative 1, 6, 12, 24, 36, 48 hour (up to 48 hours).
11 secondary outcomes
Sedation Scale
Time frame: postoperative 1, 6, 24, 48 hour
Nausea and Vomiting Categorical Score
Time frame: postoperative 1, 6, 24, 48 hour
Rescue Analgesic Use
Time frame: postoperative 1, 6, 12, 24, 36, 48 hour
Rescue Antiemetics Use
Time frame: postoperative 1, 6, 12, 24, 36, 48 hour
Time to the First Request of Analgesics
Time frame: an expected average of 5 days
Pruritus
Time frame: postoperative 1, 6, 24, 48 hour
Quality of Recovery 40
Time frame: postoperative 48 hour
Heart Rate Variability
Time frame: preoperative, postoperative 1 hour and 1 day
Time to Flatus
Time frame: an expected average of 5 days
Length of Hospital Stay
Time frame: an expected average of 5 days
Number of Participants With Intervention-related Complication
Time frame: an expected average of 5 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Chuen-Chau Chang, PhD principal investigator
Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transversus abdominis plane block and local infiltration in people with Postoperative Pain, run by Taipei Medical University Hospital at 1 site in Taiwan.
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 3 inclusion and 5 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 8 Jun 2015. 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 Taiwan. 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?
Yes. Results are posted in the registry (first posted 8 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 (NRS: Numerical Rating Scale) (time frame: postoperative 24 hour dynamic). 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 8 Jun 2015.