Nerve BlockNCT06044779
TAP vs. ESP Block for Gynecological Post Operative Pain
A study testing Transversus Abdominis Plane Block using 0.25% Bupivacaine and Erector Spinae Plane Block using 0.25% Bupivacaine in people with Nerve Block and Pain, Postoperative, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial summary
The goal of this double blind randomized controlled trial is to compare transversus abdominis plane block and erector spinae plane block in gynecological surgery patients. The main questions it aims to answer are: What are the numerical post-operative pain scores in these two groups? Is there any significant… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Nerve Block, Pain, Postoperative
- What is being tested?
- Transversus Abdominis Plane Block using 0.25% Bupivacaine and Erector Spinae Plane Block using 0.25% Bupivacaine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndonesia
- Study dates
- 27 Dec 2022to 26 Mar 2023
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with gynecological surgery techniques with a median incision include: hysterectomy, myomectomy, salpingectomy, ovarectomy and ovarian cystectomy.
- Subjects with physical status based on the American Society of Anesthesiologists (ASA) in categories I-II
- Subjects who are willing to sign informed consent form.
Who cannot join
- The patient has a history of allergies to local anesthetic drugs used for TAP blockade or ESP blockade and is allergic to morphine.
- Patients who have skin infections at the injection site.
- Patients with a history of chronic pain, namely a history of pain for more than 1 month obtained from history taking.
- Patients with a history of chronic pain treatment obtained from history taking.
- Patients with impaired kidney function (Ureum >39 mg/dL; Creatinine >1.3 mg/dL) and liver (SGOT >37 U/L; SGPT >59 U/L), myopathy, coagulopathy obtained from the results of supporting examinations, heart rhythm disorders obtained from the results of an EKG examination and neurological disorders in the form of hypesthesia or paraesthesia obtained from the results of a physical examination in the form of a sensory examination.
- The patient is pregnant as determined by history taking.
- Patients who are illiterate as obtained from history taking.
- The patient was uncooperative during examination.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transversus Abdominis Plane (TAP) Block and Erector Spinae Plane (ESP) Block Comparison on Postoperative Pain and the Need for Morphine in Gynecological Surgery Patients Who Underwent Median Incision in Hasan Sadikin General Hospital
The goal of this double blind randomized controlled trial is to compare transversus abdominis plane block and erector spinae plane block in gynecological surgery patients. The main questions it aims to answer are:
- What are the numerical post-operative pain scores in these two groups?
- Is there any significant difference in the numerical post-operative pain scores between subjects who underwent TAP block and subjects who underwent ESP block?
- What are the differences in the time needed for additional morphine in these two groups?
- Is there any significant differences in the time needed for additional morphine between subjects who underwent TAP block and subjects who underwent ESP block?
- Conditions
- Nerve Block, Pain, Postoperative
- Being tested
- Transversus Abdominis Plane Block using 0.25% Bupivacaine, Erector Spinae Plane Block using 0.25% Bupivacaine
- Keywords
- Transversus Abdominis Plane Block, Erector Spinae Plane Block, Postoperative Pain, Gynecological Surgery
- 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 Block using 0.25% BupivacaineProcedure or surgery
TAP block regional anesthesia with ultrasound guidance with administration of 20 mL of 0.25% Bupivacaine in the abdominal wall before the operation is completed. The patient was also fitted with a morphine PCA device with a background dose of 5 µg/kgBW/hour and a rescue dose of 1 mg with a lockout interval of 10 minutes.
Erector Spinae Plane Block using 0.25% BupivacaineProcedure or surgery
Regional anesthesia ESP block under ultrasound guidance with 20 mL of 0.25% bupivacaine at the tip of the transverse process at the T9 level before completion of surgery. The patient was also fitted with a morphine PCA device with a background dose of 5 µg/kgBW/hour and a rescue dose of 1 mg with a lockout interval of 10 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Transversus Abdominis Plane (TAP) Anesthestic Block | Active comparator | Ultrasound-guided TAP block is done using 20 mL of 0.25% Bupivacaine administered at the lateral abdominal wall between the costal margin and the iliac crest Receives: Procedure: Transversus Abdominis Plane Block using 0.25% Bupivacaine |
| Erector Spinae Plane (ESP) Anesthetic Block | Active comparator | Ultrasound-guided ESP block is done using 20 mL of 0.25% Bupivacaine administered at the tip of the transverse process at the T9 level Receives: Procedure: Erector Spinae Plane Block using 0.25% Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Numerical Rating Scale
The degree of pain assessment is classified based on the Numeric Rating Scale pain assessment scale) with the lowest scale being no pain (value 0), up to the heaviest pain scale (value 10) when still, namely when the patient does not make any movement and moves, namely when mobilization is carried out on the left side and right tilt
Measured: 24 hours post operative
Secondary outcomes (2)
Total postoperative morphine requirements
The total amount of morphine required by study subjects over 24 hours to reduce postoperative pain
Measured: 24 hours post operative
Time of first need for analgesic rescue
The time required by study subjects to press the PCA to obtain analgesics was first calculated from the time it was installed in the recovery room
Measured: 24 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start27 Dec 2022
- Primary completion26 Mar 2023
- Study completion26 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve BlockStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Doddy M Tavianto, MD, Study director, Faculty of Medicine Universitas Padjadjaran BandungOsmond M Pison, MD, Study director, Faculty of Medicine Universitas Padjadjaran BandungAzka P Rakhimulllah, MD, Principal investigator, Faculty of Medicine Universitas Padjadjaran Bandung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06044779
- Sponsor's protocol ID
- AN-202309.03
- Status last verified
- Sep 2023
- First submitted
- 10 Sep 2023
- Last updated
- 22 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transversus Abdominis Plane (TAP) Block and Erector Spinae Plane (ESP) Block Comparison on Postoperative Pain and the Need for Morphine in Gynecological Surgery Patients Who Underwent Median Incision in Hasan Sadikin General Hospital
- ClinicalTrials.gov ID
- NCT06044779
- Acronym / sponsor ID
- AN-202309.03
- Conditions
- Nerve Block, Pain, Postoperative
- Keywords
- Transversus Abdominis Plane Block, Erector Spinae Plane Block, Postoperative Pain, Gynecological Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Study start
- 27 Dec 2022 (actual)
- Primary completion
- 26 Mar 2023 (actual)
- Study completion
- 26 Mar 2023 (actual)
- First posted
- 21 Sep 2023 (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.
The goal of this double blind randomized controlled trial is to compare transversus abdominis plane block and erector spinae plane block in gynecological surgery patients. The main questions it aims to answer are:
- What are the numerical post-operative pain scores in these two groups?
- Is there any significant difference in the numerical post-operative pain scores between subjects who underwent TAP block and subjects who underwent ESP block?
- What are the differences in the time needed for additional morphine in these two groups?
- Is there any significant differences in the time needed for additional morphine between subjects who underwent TAP block and subjects who underwent ESP block?
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transversus Abdominis Plane (TAP) Anesthestic Block | Active comparator | Procedure: Transversus Abdominis Plane Block using 0.25% BupivacaineUltrasound-guided TAP block is done using 20 mL of 0.25% Bupivacaine administered at the lateral abdominal wall between the costal margin and the iliac crest |
| Erector Spinae Plane (ESP) Anesthetic Block | Active comparator | Procedure: Erector Spinae Plane Block using 0.25% BupivacaineUltrasound-guided ESP block is done using 20 mL of 0.25% Bupivacaine administered at the tip of the transverse process at the T9 level |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects with gynecological surgery techniques with a median incision include: hysterectomy, myomectomy, salpingectomy, ovarectomy and ovarian cystectomy.
- Subjects with physical status based on the American Society of Anesthesiologists (ASA) in categories I-II
- Subjects who are willing to sign informed consent form.
Key exclusion criteria (8 listed)
- The patient has a history of allergies to local anesthetic drugs used for TAP blockade or ESP blockade and is allergic to morphine.
- Patients who have skin infections at the injection site.
- Patients with a history of chronic pain, namely a history of pain for more than 1 month obtained from history taking.
- Patients with a history of chronic pain treatment obtained from history taking.
- Patients with impaired kidney function (Ureum >39 mg/dL; Creatinine >1.3 mg/dL) and liver (SGOT >37 U/L; SGPT >59 U/L), myopathy, coagulopathy obtained from the results of supporting examinations, heart rhythm disorders obtained from the results of an EKG examination and neurological disorders in the form of hypesthesia or paraesthesia obtained from the results of a physical examination in the form of a sensory examination.
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 Block using 0.25% BupivacaineTAP block regional anesthesia with ultrasound guidance with administration of 20 mL of 0.25% Bupivacaine in the abdominal wall before the operation is completed. The patient was also fitted with a morphine PCA device with a background dose of 5 µg/kgBW/hour and a rescue dose of 1 mg with a lockout interval of 10 minutes. | Procedure or surgery | Transversus Abdominis Plane (TAP) Anesthestic Block |
| Erector Spinae Plane Block using 0.25% BupivacaineRegional anesthesia ESP block under ultrasound guidance with 20 mL of 0.25% bupivacaine at the tip of the transverse process at the T9 level before completion of surgery. The patient was also fitted with a morphine PCA device with a background dose of 5 µg/kgBW/hour and a rescue dose of 1 mg with a lockout interval of 10 minutes. | Procedure or surgery | Erector Spinae Plane (ESP) Anesthetic Block |
Primary outcome
Postoperative Numerical Rating Scale
Time frame: 24 hours post operative
The degree of pain assessment is classified based on the Numeric Rating Scale pain assessment scale) with the lowest scale being no pain (value 0), up to the heaviest pain scale (value 10) when still, namely when the patient does not make any movement and moves, namely when mobilization is carried out on the left side and right tilt
2 secondary outcomes
Total postoperative morphine requirements
Time frame: 24 hours post operative
Time of first need for analgesic rescue
Time frame: 24 hours post operative
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 22 Sep 2023.
Related trials for Nerve Block
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Not yet recruiting
Nerve Block of the Vastus Medialis and Anterior Obturator Branch in Anterior Cruciate Ligament Reconstruction With DIDT Graft
Anterior Cruciate Ligament (ACL) Reconstruction Surgery
RecruitingObservational study
Office-Based Superior Laryngeal Nerve Block for Treatment of Neurogenic Cough
Cough
RecruitingPhase 4
PENG vs L-ESPB With S-ESPB for Analgesia in Total Hip Arthroplasty
Hip Osteoarthritis, Hip Arthropathy
RecruitingPhase 4
Individualised Cryoneurolysis to Treat Pain in the Context of Spasticity in the Upper and Lower Extremities
Centreal Neurological Condition, Acquired Brain Injury (Including Stroke)
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.
Doddy M Tavianto, MD study director
Faculty of Medicine Universitas Padjadjaran Bandung
Osmond M Pison, MD study director
Faculty of Medicine Universitas Padjadjaran Bandung
Azka P Rakhimulllah, MD principal investigator
Faculty of Medicine Universitas Padjadjaran Bandung
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 using 0.25% Bupivacaine and Erector Spinae Plane Block using 0.25% Bupivacaine in people with Nerve Block and Pain, Postoperative, run by Universitas Padjadjaran at 1 site in Indonesia.
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 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 22 Sep 2023. 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 Indonesia. 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 Numerical Rating Scale (time frame: 24 hours post operative). 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 22 Sep 2023.