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Postoperative Pain Following HysterectomyTAPNCT07139691

TAP Block With Lidocaine and Ropivacaine 0.2% (0.4 ml/kg/Side) for Pain and Opioid Reduction After Hysterectomy

A study testing Pre-incisional Transversus Abdominis Plane (TAP) block performed under ultrasound guidance. The block will be administered bilaterally using a mixture of lidocaine and ropivacaine 0.2% and Participants in this arm will receive standard analgesia for postoperative pain management following elective hysterectomy in people with Postoperative Pain Following Hysterectomy, run by Matild Keresztes at 1 site in Romania.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this study is to evaluate whether the Transversus Abdominis Plane (TAP) block can effectively reduce postoperative pain and opioid consumption in patients undergoing elective hysterectomy. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Pre-incisional Transversus Abdominis Plane (TAP) block performed under ultrasound guidance. The block will be administered bilaterally using a mixture of lidocaine and ropivacaine 0.2% and Participants in this arm will receive standard analgesia for postoperative pain management following elective hysterectomy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
1 siteRomania
Study dates
12 Jan 2024to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Elective surgery
  • Subumbilical incision (median, Phannenstil)
  • Total or subtotal hysterectomy
  • Age over 18 years

Who cannot join

  • Patient refusal
  • Infection at the puncture site
  • Chronic pain
  • Chronic use of analgesics
  • Contraindications to NSAIDs, local anesthetics, or opioids (e.g., tramadol: antidepressants, epileptic disorders)
  • Severe hepatic disease
  • Renal insufficiency (Creatinine Clearance ≤ 30 ml/min)
  • Coagulopathy (Platelet count ≤ 75,000, INR ≥ 1.4)

Trial locations and contacts

1 site in 1 country.

Romania1 site
  • County Emergency Clinical Hospital of Targu Mureș

    Târgu Mureş, Mureș County, 540136

Other trials in Romania

About this study

Official title: Efficacy of TAP Block in Postoperative Pain Management for Elective Hysterectomy: a Randomized Controlled Clinical Trial

The goal of this study is to evaluate whether the Transversus Abdominis Plane (TAP) block can effectively reduce postoperative pain and opioid consumption in patients undergoing elective hysterectomy.

The main questions it aims to answer are:

Read more

Primary outcome: Does performing a pre-incisional TAP block reduce postoperative pain scores and opioid consumption compared to standard analgesic management?

Secondary outcomes:

Does TAP block reduce intraoperative opioid requirements during hysterectomy? Does TAP block enhance postoperative recovery and facilitate early mobilization? Does TAP block reduce the length of hospital stay? Does TAP block improve overall patient satisfaction following hysterectomy? If there is a comparison group: Researchers will compare patients receiving TAP block with lidocaine and ropivacaine (0.2%, 0.4 ml/kg per side) to patients receiving standard analgesia without TAP block to see if the TAP block provides superior pain relief, lowers opioid needs, and improves recovery outcomes.

Participants will:

Undergo elective total or subtotal hysterectomy. Receive either a TAP block (intervention group) or standard analgesic management (control group).

Have their intraoperative and postoperative opioid consumption, pain scores, recovery parameters, and satisfaction assessed.

Read the detailed description

Hysterectomy is a common gynecological surgical procedure involving the removal of the uterus. The procedure may be total or subtotal, and is frequently associated with moderate to severe postoperative pain. Effective management of this pain is crucial and is typically achieved through multimodal analgesia. This approach includes regional nerve blocks, systemic analgesics (oral and intravenous), and adjunctive therapies (physical or psychological), resulting in reduced opioid requirements, minimized side effects, and shorter hospital stays.

The transversus abdominis plane (TAP) block is a regional anesthesia technique involving the injection of a local anesthetic between the transversus abdominis and internal oblique muscles. This targets the thoracolumbar nerves (T6-L1) and provides effective analgesia for the anterior abdominal wall. When performed under ultrasound guidance following abdominal surgery, the TAP block has demonstrated benefits including decreased incisional pain, reduced opioid consumption, and improved postoperative mobilization.

This is a prospective, randomized, comparative clinical trial conducted within the Department of Obstetrics and Gynecology at Mureș County Emergency Clinical Hospital. The study period extends from January 2024 to December 2025 or until the target sample size is reached. All anesthetic and surgical interventions utilized are within standard clinical practice; no experimental drugs or procedures are employed.

The study compares two multimodal analgesia protocols to identify the most effective and satisfactory method of postoperative pain management. All participants will provide written informed consent prior to enrollment.

Participants will be randomly allocated into two groups using a computer-generated randomization application on the day of surgery. The anesthesiologist performing the TAP block will be the only staff member aware of group allocation.

To maintain blinding, all participants will leave the operating room with bilateral lateral abdominal dressings, regardless of group assignment. Postoperative evaluators will be blinded to group allocation.

The transversus abdominis plane (TAP) block will be performed under ultrasound guidance using a Sonosite ultrasound system equipped with a linear probe (6-15 MHz). The block will be executed after induction of general anesthesia, utilizing the lateral approach.

The procedure begins by positioning the ultrasound probe at the level of the umbilicus, oriented transversely to identify the rectus abdominis muscle. The probe is then moved laterally and slightly posteriorly to visualize the three muscle layers of the lateral abdominal wall in cross-section: External oblique, Internal oblique, Transversus abdominis.

The final probe position will be between the iliac crest and the costal margin, where the muscle layers are clearly visualized. Under direct ultrasound visualization, the needle (Stimuplex Ultra 360, 20G × 6, 30° bevel, 100-150 mm) is inserted in-plane, from medial to lateral, puncturing the skin above the probe and advancing through the tissue under the ultrasound beam.

The needle is advanced until it reaches the fascial plane between the internal oblique and transversus abdominis muscles. Correct placement is confirmed by the appearance of the "unzipping" or hydro-dissection effect upon injection of a small volume of local anesthetic, indicating separation of the fascial layers.

The local anesthetic solution is then injected in increments of 5 ml per side, with aspiration performed after each increment to exclude intravascular needle placement.

The entire TAP block procedure is conducted under strict aseptic conditions, including:

  • Skin disinfection with Braunol iodine solution
  • Use of sterile gloves
  • Use of a sterile ultrasound probe cover
  • Sterile handling of all equipment and medications Preoperative data collected will include age, weight, height, body mass index (BMI), ASA score, comorbidities, gynecologic diagnosis, and baseline Quality of Recovery score (QoR-15).

Intraoperative data will include: time of anesthesia induction, time of TAP block (if applicable), time of surgical incision, total surgery duration, opioid consumption, heart rate and blood pressure.

Intraoperative pain will be defined as a ≥20% increase in heart rate and/or blood pressure compared to baseline values recorded one day prior to surgery.

Postoperative assessments will include:

  • Pain intensity at 0, 1, 4, 6, and 24 hours (at rest and during movement)
  • Numeric Rating Scale (0-10)
  • Patient satisfaction score at 24 hours
  • QoR-15 score at 48 hours Data will be recorded using standardized intraoperative and postoperative forms. The intraoperative form will be completed by the anesthesiologist performing the surgery. The postoperative form will be completed by a blinded evaluator (resident or specialist from another unit). All data will be entered into Microsoft Excel and analyzed using GraphPad Prism.

Results will be statistically analyzed and interpreted to identify differences in pain control, opioid consumption, recovery, and patient satisfaction between the two groups. Conclusions will guide the development of updated institutional pain management protocols for hysterectomy.

Being tested
Pre-incisional Transversus Abdominis Plane (TAP) block performed under ultrasound guidance. The block will be administered bilaterally using a mixture of lidocaine and ropivacaine 0.2%, Participants in this arm will receive standard analgesia for postoperative pain management following elective hysterectomy
Keywords
Transversus Abdominis Plane Block, Postoperative Pain Management, Hysterectomy

What participants receive

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

  • Pre-incisional Transversus Abdominis Plane (TAP) block performed under ultrasound guidance. The block will be administered bilaterally using a mixture of lidocaine and ropivacaine 0.2%Procedure or surgery

    After the induction of general anesthesia, bilateral TAP block will be performed in patients from Group 1. The administered dose will include 0.2% lidocaine combined with 0.2% ropivacaine, at a dose of 0.4 ml/kg per side, without exceeding toxic dose limits per kg.

  • Participants in this arm will receive standard analgesia for postoperative pain management following elective hysterectomyDrug

    Participants in this arm will receive standard multimodal systemic analgesia for postoperative pain management following elective hysterectomy. The regimen includes Paracetamol (oral or intravenous) 1g/24 hour, Ibuprofen IV 1200 mg/24 hour, or Parecoxib 80 mg/24 hour IV, and Tramadol 100 mg IV. Additional rescue doses of Tramadol (50-100 mg IV every 4-6 hours) may be administered based on pain intensity, with a maximum of 400 mg/24 hours (or 300 mg/24 hours for patients aged ≥75 years). No Transversus Abdominis Plane (TAP) block will be performed in this group. Pain intensity, opioid use, and postoperative recovery scores will be evaluated and compared with the TAP block intervention group.

Study groups in NCT07139691
Study groupRoleWhat they receive
Arm 1: TAP Block with Lidocaine and RopivacaineExperimentalParticipants in this arm will receive a pre-incisional Transversus Abdominis Plane (TAP) block performed under ultrasound guidance. The block will be administered bilaterally using a mixture of lidocaine and ropivacaine 0.2% with a calculated dose of 0.4 ml/kg per side, in addition to standard analgesia.
Receives: Procedure: Pre-incisional Transversus Abdominis Plane (TAP) block performed under ultrasound guidance. The block will be administered bilaterally using a mixture of lidocaine and ropivacaine 0.2%
Arm 2: Standard Analgesia (Control)Active comparatorParticipants in this arm will receive standard analgesia for postoperative pain management following elective hysterectomy. This regimen typically includes systemic analgesics (e.g., intravenous or oral non-opioid analgesics and opioids as needed) but does not include a Transversus Abdominis Plane (TAP) block.
Receives: Drug: Participants in this arm will receive standard analgesia for postoperative pain management following elective hysterectomy

What is being measured

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

  1. Cumulative Opioid Consumption (Tramadol)

    Total intravenous Tramadol administered for postoperative pain management will be recorded during the first 24 hours following elective hysterectomy. Unit of Measure: Milligrams (mg) of IV Tramadol

    Measured: From end of surgery (arrival in recovery room) to 24 hours postoperatively

  2. Postoperative Pain Intensity

    Pain intensity will be assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain). Scores will be recorded at 0, 1, 4, 6, and 24 hours postoperatively, both at rest and during movement.

    Measured: From end of surgery to 24 hours postoperatively

Secondary outcomes (4)
  1. Intraoperative Opioid Consumption During Hysterectomy

    Total amount of opioids administered intraoperatively will be recorded. The outcome will assess whether performing a pre-incisional bilateral TAP block reduces opioid requirements during the surgical procedure compared to standard multimodal analgesia alone.

    Measured: From induction of anesthesia until completion of surgery

  2. Postoperative Quality of Recovery Assessed by QoR-15

    The Quality of Recovery-15 (QoR-15) questionnaire will be used to evaluate postoperative recovery in patients undergoing elective hysterectomy. QoR-15 is a validated tool that assesses multiple domains of recovery including physical comfort, pain, physical independence, psychological support, and emotional state. Scores range from 0 to 150, with higher scores indicating better recovery. The study will assess whether a pre-incisional bilateral TAP block improves QoR-15 scores compared to standard multimodal analgesia.

    Measured: At 48 hours after completion of surgery

  3. Length of Hospital Stay

    The total duration of hospitalization from the end of surgery until patient discharge. This outcome will evaluate whether a pre-incisional bilateral TAP block reduces the length of hospital stay compared to standard multimodal analgesia in patients undergoing elective hysterectomy.

    Measured: Up to 2 weeks

  4. Patient Satisfaction with Postoperative Pain Management

    Patient satisfaction with postoperative pain management will be assessed using a 10-item Patient Satisfaction Questionnaire. Each item consists of a statement regarding the participant's experience with pain control, and responses are provided on a 5-point Likert scale:

    1. = Strongly Disagree
    2. = Disagree
    3. = Neutral
    4. = Agree
    5. = Strongly Agree The total score is calculated by summing the responses to all 10 items. The minimum total score is 10, and the maximum total score is 50, with higher scores indicating greater satisfaction. This outcome will evaluate whether the addition of a pre-incisional bilateral TAP block improves patient satisfaction compared to standard multimodal analgesia.

    Measured: At 24 hours after completion of surgery

Timeline

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

  1. First posted24 Aug 2025
  2. Study start12 Jan 2024
  3. Primary completion1 Jul 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
82 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07139691
Sponsor's protocol ID
651/12.01.2024
Acronym
TAP
Status last verified
Aug 2025
First submitted
29 Jul 2025
Last updated
24 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual participant data (IPD) underlying the results of this study will be made available to other researchers upon reasonable request for secondary analyses, following publication of the primary results. Access will be granted through a secure data-sharing agreement.

Questions about this trial

What is this clinical trial studying?

A study testing Pre-incisional Transversus Abdominis Plane (TAP) block performed under ultrasound guidance. The block will be administered bilaterally using a mixture of lidocaine and ropivacaine 0.2% and Participants in this arm will receive standard analgesia for postoperative pain management following elective hysterectomy in people with Postoperative Pain Following Hysterectomy, run by Matild Keresztes at 1 site in Romania.

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 4 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: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2025. 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 Romania. 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?

This study is still under way. Results are not available in the source record yet.

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?

Cumulative Opioid Consumption (Tramadol) (time frame: From end of surgery (arrival in recovery room) to 24 hours postoperatively). 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 24 Aug 2025.

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