Analgesia, Patient-ControlledNCT05188794

Comparison of Two Different Approach TAP Block on Pain Management of Laparoscopic Nephrectomy

A study testing lateral tap block and posterior tap block in people with Analgesia, Patient-Controlled and Postoperative Pain, Acute, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Primary aim is to compare the effectiveness of the posterior approach Transversus abdominis plane block (P-TAP) and the lateral approach Transversus abdominis plane block (L-TAP) technique on the pain management of the laparoscopic nephrectomy in terms of visual analog pain scale and postoperative opioid consumption. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Analgesia, Patient-Controlled, Postoperative Pain, Acute
What is being tested?: lateral tap block and posterior tap block
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 88 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Jan 2022to 15 May 2022
Phase: Interventional
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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

ASAI-III patients undergoing laparoscopic nephrectomy
18<BMI<40

Who cannot join

infection at the block site
coagulation disorder
pregnancy
kidney failure
liver failure
heart failure
allergy to local anesthetics
patient refusal

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Ankara City Hospital,Bilkent
Ankara, Cankay

Other trials in Turkey (Türkiye)

About this study

Official title: Comparison of Two Different Approach Ultrasound Guided TAP Block on Pain Management of Laparoscopic Nephrectomy: Posterior or Lateral Approach?

Read the detailed description

Patients included in the study will be randomized into two groups (group L and group P) in the preoperative period. Following routine anesthesia induction TAP block will be applied to group L patients with the lateral approach technique, and to group P patients with the posterior approach technique. Regional block complications will be recorded.

Standard laparoscopic nephrectomy surgical method will be applied. 1g of paracetamol and 4mg of dansetron will be administered to both groups 15 minutes before the end of the operation. The pain intensity of the patients will be questioned and VAS values will be recorded at 0, 1, 2, 6, 12 and 24 hours postoperatively.

Conditions: Analgesia, Patient-Controlled, Postoperative Pain, Acute
Being tested: lateral tap block, posterior tap block
Medical subject headings: Agnosia, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

lateral tap blockProcedure or surgery
In the axial plane on the midaxillary line between the subcostal margin and the iliac crest with a linear probe using a 12 cm insulated nerve block needle is advanced in planely from skin, external, and internal oblique muscles to the target of fascial plane between the internal oblique and the transversus abdominis muscles.
posterior tap blockProcedure or surgery
In the axial plane on the midaxillary line a linear probe using a 12 cm insulated nerve block needle is advanced posteriorly to the most posterior limit of the TAP between the internal oblique and transversus abdominis muscles.

Study groups in NCT05188794
Study group	Role	What they receive
group L	Active comparator	Lateral transversus abdominis plane(TAP) block Receives: Procedure: lateral tap block
Group P	Active comparator	Posterior transversus abdominis plane block Receives: Procedure: posterior tap block

What is being measured

The primary outcome is the main question the study is designed to answer.

Visual analog pain scale 0
Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.
Measured: at the PACU arrival
Visual analog pain scale 1
Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.
Measured: Postoperative first hour
Visual Analog Pain scale 2
Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.
Measured: Postoperative second hour
Visual analog pain scale 6
Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.
Measured: Postoperative sixth hour
Visual Analog Pain scale 12
Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.
Measured: Postoperative 12. hour
Visual Analog Pain scale 18
Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.
Measured: Postoperative18. hour
Visual Analog Pain scale 24
Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.
Measured: Postoperative 24. hour
opioid comsuption
Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.
Measured: Within 24 hours postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 202215 May 2022

First posted12 Jan 2022
Study start1 Jan 2022
Primary completion1 May 2022
Study completion15 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Analgesia, Patient-ControlledStudies of the same condition, open and under way.
More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 88 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05188794
Sponsor's protocol ID: E1-21-1814
Status last verified: Apr 2024
First submitted: 22 Nov 2021
Last updated: 5 Apr 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Recruiting
WATER IV PCa (AS Sub-study)
Localized Prostate Cancer
RecruitingEarly Phase 1
Evaluating Pain Control Strategies in Postpartum Patients on Opioid Use Disorder Medications.
Substance Use Disorder (SUD)
Not yet recruiting
Comparison of Serratus Posterior Superior Intercostal Plane Block and Rhomboid Intercostal Block in Patients Undergoing Breast Cancer Surgery
Breast Cancer, Lymph Node Dissection
Recruiting
Virtual Reality-Based Hypnotherapy for Pain, Sleep, and Mood in Spinal Cord Injury
Spinal Cord Injuries (SCI), Chronic Pain

All Analgesia, Patient-Controlled trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Two Different Approach Ultrasound Guided TAP Block on Pain Management of Laparoscopic Nephrectomy: Posterior or Lateral Approach?
ClinicalTrials.gov ID: NCT05188794
Acronym / sponsor ID: E1-21-1814
Conditions: Analgesia, Patient-Controlled, Postoperative Pain, Acute
Study type: Interventional
Recruitment status: Completed
Enrolment: 88 participants (actual)
Lead sponsor: Ankara City Hospital BilkentUniversity, hospital or other
Study start: 1 Jan 2022 (actual)
Primary completion: 1 May 2022 (actual)
Study completion: 15 May 2022 (actual)
First posted: 12 Jan 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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
group L	Active comparator	Procedure: lateral tap blockLateral transversus abdominis plane(TAP) block
Group P	Active comparator	Procedure: posterior tap blockPosterior transversus abdominis plane block

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

ASAI-III patients undergoing laparoscopic nephrectomy
18<BMI<40

Key exclusion criteria (8 listed)

infection at the block site
coagulation disorder
pregnancy
kidney failure
liver failure

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
lateral tap blockIn the axial plane on the midaxillary line between the subcostal margin and the iliac crest with a linear probe using a 12 cm insulated nerve block needle is advanced in planely from skin, external, and internal oblique muscles to the target of fascial plane between the internal oblique and the transversus abdominis muscles.	Procedure or surgery	group L
posterior tap blockIn the axial plane on the midaxillary line a linear probe using a 12 cm insulated nerve block needle is advanced posteriorly to the most posterior limit of the TAP between the internal oblique and transversus abdominis muscles.	Procedure or surgery	Group P

Primary outcome

Visual analog pain scale 0
Time frame: at the PACU arrival
Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.
Visual analog pain scale 1
Time frame: Postoperative first hour
Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.
Visual Analog Pain scale 2
Time frame: Postoperative second hour
Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.
Visual analog pain scale 6
Time frame: Postoperative sixth hour
Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.
Visual Analog Pain scale 12
Time frame: Postoperative 12. hour
Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.
Visual Analog Pain scale 18
Time frame: Postoperative18. hour
Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.
Visual Analog Pain scale 24
Time frame: Postoperative 24. hour
Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.
opioid comsuption
Time frame: Within 24 hours postoperatively
Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.

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 5 Apr 2024.
Individual participant dataSharing planned: No

Related trials for Analgesia, Patient-Controlled

Active, not recruiting
Efficacy of Laparoscopic-Assisted TAP Block in Laparoscopic Appendectomy
Appendectomy, Laparoscopic, Blockades Neuromuscular
Recruiting
WATER IV PCa (AS Sub-study)
Localized Prostate Cancer
RecruitingEarly Phase 1
Evaluating Pain Control Strategies in Postpartum Patients on Opioid Use Disorder Medications.
Substance Use Disorder (SUD)
Not yet recruiting
Comparison of Serratus Posterior Superior Intercostal Plane Block and Rhomboid Intercostal Block in Patients Undergoing Breast Cancer Surgery
Breast Cancer, Lymph Node Dissection
Recruiting
Virtual Reality-Based Hypnotherapy for Pain, Sleep, and Mood in Spinal Cord Injury
Spinal Cord Injuries (SCI), Chronic Pain

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.

MİYASE SERAP DİKER, DOCTOR principal investigator

ANKARA CİTY HOSPİTAL

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 8 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 5 Apr 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 Turkey (Türkiye). 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?

Visual analog pain scale 0 (time frame: at the PACU arrival). The study lists 8 primary outcomes in all. 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 NCT05188794.

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 5 Apr 2024.