CLINICAL TRIAL

TAP block for Pain, Postoperative

EnrollingByInvitation · 18+ · All Sexes · Clinton Township, MI

This study is evaluating whether an early intraoperative transverse abdominis plane block (TAP block) will provide superior analgesia to a late intraoperative TAP block.

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About the trial for Pain, Postoperative

Eligible Conditions
Obesity · Pain, Postoperative

Treatment Groups

This trial involves 2 different treatments. TAP Block is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Experimental Group 1
TAP block
PROCEDURE
Experimental Group 2
TAP block
PROCEDURE

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
TAP block
2010
Completed Phase 4
~1380

Side Effect Profile for 0.125% Bupivacaine

0.125% Bupivacaine
Show all side effects
Hematoma
8%
Musculoskeletal and connective tissue disorder - Chest wall necrosis, specify
2%
Anemia
2%
Hypotension
2%
Muscle cramp
2%
Wound complication
2%
Otitis media
2%
Urinary Tract Infection
2%
Shingles
2%
Thromboembolic event
2%
Skin and subcutaneous tissue disorders - Other, specify
2%
Peripheral sensory neuropathy
2%
Headache
2%
Localized Edema
2%
Bruising
2%
Nausea
2%
Bullous dermatitis
2%
Skin ulceration
0%
Upper respiratory infection
0%
Fever
0%
Urine output decreased
0%
Edema Limbs
0%
Anxiety
0%
Sinus tachycardia
0%
Pain in extremity
0%
Pruritus
0%
Vasovagal reaction
0%
Vomiting
0%
This histogram enumerates side effects from a completed 2021 Phase 3 trial (NCT02601027) in the 0.125% Bupivacaine ARM group. Side effects include: Hematoma with 8%, Musculoskeletal and connective tissue disorder - Chest wall necrosis, specify with 2%, Anemia with 2%, Hypotension with 2%, Muscle cramp with 2%.

Eligibility

This trial is for patients born any sex aged 18 and older. There is one eligibility criterion to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Undergoing laparoscopic sleeve gastrectomy
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: Day of surgery to day of discharge up to 30 days
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Day of surgery to day of discharge up to 30 days.
View detailed reporting requirements
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Measurement Requirements

This trial is evaluating whether TAP block will improve 1 primary outcome and 2 secondary outcomes in patients with Pain, Postoperative. Measurement will happen over the course of 24 hours post-operatively. These pain scales will be done by nurses/nursing aids taking vitals..

Patient reported pain
24 HOURS POST-OPERATIVELY. THESE PAIN SCALES WILL BE DONE BY NURSES/NURSING AIDS TAKING VITALS.
Using the numerical assessment system, the patient will report their pain by choosing a number 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10. On the scale, 0 means no pain (best outcome) and 10 means the most pain (worst outcome). The patients will identify where on the spectrum their pain lays prior to receiving any possible pain medication.The pain scores will be averaged within the two groups at each time interval collected.
Narcotic use
STARTING WITH ADMINISTRATION OF OPIOID MEDICATION IN PACU UNTIL TIME OF DISCHARGE UP TO 30 DAYS
We will measure the amount of opioid medication given to the patients.
Length of stay
DAY OF SURGERY TO DAY OF DISCHARGE UP TO 30 DAYS
Days spent in hospital including day of surgery

Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for pain, postoperative?

Several medications and procedures have been found to be effective to manage pain and postoperative pain for patients with chronic postoperative pain. These include non-steroidal anti-inflammatory drugs, paracetamol, preoperative analgesia (painkillers), parenteral opioids, and neuromodulating medications. Although all the treatments, medications, and procedures have their advantages, they can also cause complications as well. However, the most important thing is to find a clinician to help the patient with them. You have been taught how to find a clinician through a patient who is in pain, visit the [AuORTS(www.auopens.org)] website.

Anonymous Patient Answer

What are the signs of pain, postoperative?

Signs of postoperative pain may include an elevated heart rate, agitation, low blood pressure, low oxygen saturation, and changes in skin temperature. The signs of low pulse, high blood pressure and low oxygen saturation typically occur shortly after surgery. Pain may be relieved by opioid or non-opioid analgesics. This pain may last from seconds after surgery to a few days after surgical intervention.\n

Anonymous Patient Answer

How many people get pain, postoperative a year in the United States?

The United States has many patients treated with surgical pain medicines, with an estimated 1.3 million people being treated annually with these drugs. Given the large number of surgeries done each year in the United States, there is a possibility that many patients are experiencing postoperative pain, despite not actually having had surgery themselves. Data from a recent study indicates a large number of patients worldwide are experiencing a common symptom of pain, postoperative.

Anonymous Patient Answer

What causes pain, postoperative?

The most reliable indicators are episodic pain complaints and pain intensity in the early post operative period. Duration of pain, sleep disturbance and mental confusion were insignificant.

Anonymous Patient Answer

Can pain, postoperative be cured?

In a recent study, findings show that most patients would choose to endure constant pain after surgery instead of continuing with a less satisfactory management. Thus, the most suitable surgical treatment should satisfy two criteria: a) that the pain should not be unbearable; and b) that patients should be kept informed and offered the best treatment possible in accordance with the specific type of operation they have had.

Anonymous Patient Answer

What is pain, postoperative?

Post-operative pain in patients undergoing surgical repair of hip fracture is not uncommonly perceived by patients as excruciating. However, nearly 50% of the patients did not report suffering post-surgically. Pain intensity was not associated with other demographic, psychological, and patient satisfaction measures. More research is needed to better understand post-surgical pain amongst patients undergoing surgical repair of hip fracture.

Anonymous Patient Answer

How does tap block work?

Anesthetic block as a method to treat postoperative pain can help minimize postoperative pain by making the patient feel comfortable and reduce the time spent on medications.

Anonymous Patient Answer

Have there been any new discoveries for treating pain, postoperative?

Even though the treatment of pain is imperative for postoperative patients, no medications, new therapeutic modalities or technologies can help with this condition. This may be due to the complexity of pain pathways and its complexity to treat. In the future, we may find new insights in this particular aspect of pain medicine.

Anonymous Patient Answer

What is tap block?

Tap technique in the treatment of postoperative pain alleviates the postural discomfort in the upper part of the body, and prevents muscle atrophy caused by the immobilization.

Anonymous Patient Answer

What is the average age someone gets pain, postoperative?

A majority of the patients were between the ages of 40-69, and the most common postoperative problems were nausea, vomiting, constipation, and dizziness. Since symptoms occur at the same time as postoperative infection and poor wound healing would preclude them, patients have a very short time to have the pain and discomfort remedied properly.

Anonymous Patient Answer

What are the latest developments in tap block for therapeutic use?

The majority of studies have shown that tap block can be used to ease postoperative pain and accelerate recovery after surgery. Tap block is more effective than intravenous opioids alone, which is very important in terms of patient safety and cost containment. However, more studies are required to compare the effectiveness of tap block with intravenous opioid medication.

Anonymous Patient Answer

Have there been other clinical trials involving tap block?

No studies have been published on tap block as an alternative technique to nerve blocks and epidural analgesia. However, there is some evidence that the technique is effective in providing postoperative pain relief, with the advantages of having a shorter operative time and less need for rescue analgesia. Given the good safety profile of tap block, further studies are warranted. The authors do not know how tap block compares to nerve block, epidural analgesia, or other postoperative pain management options.

Anonymous Patient Answer
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