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

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:

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Postoperative Pain Following Hysterectomy
• Intervention / Treatment: 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%; Drug: Participants in this arm will receive standard analgesia for postoperative pain management following elective hysterectomy

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.

• Study Type: Interventional
• Enrollment (Estimated): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Romania
  • Mureș
    • Târgu Mureș, Mureș, Romania, 540136
      • County Emergency Clinical Hospital of Targu Mureș

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1: TAP Block with Lidocaine and Ropivacaine; Participants 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.	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%; 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.
Active Comparator: Arm 2: Standard Analgesia (Control); Participants 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.	Drug: Participants in this arm will receive standard analgesia for postoperative pain management following elective hysterectomy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From end of surgery (arrival in recovery room) to 24 hours postoperatively
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.	From end of surgery to 24 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From induction of anesthesia until completion of surgery
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.	At 48 hours after completion of surgery
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.	Up to 2 weeks
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: = Strongly Disagree; = Disagree; = Neutral; = Agree; = 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.	At 24 hours after completion of surgery

Collaborators and Investigators

• Sponsor: Matild Keresztes
• Investigators: Study Chair: Janos Szederjesi, MD, PhD, Dept. of Anesthesiology & Intensive Care, George Emil Palade Univ. of Medicine & Pharmacy, Târgu Mureș; Principal Investigator: Matild Keresztes, MD, Dept. of Anesthesiology & Intensive Care, George Emil Palade Univ. of Medicine & Pharmacy, Târgu Mureș

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 29, 2025
• First Submitted That Met QC Criteria: August 18, 2025
• First Posted (Actual): August 24, 2025

Study Record Updates

• Last Update Posted (Actual): August 24, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: Hysterectomy; Transversus Abdominis Plane Block; Postoperative Pain Management
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Anti-Arrhythmia Agents; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Membrane Transport Modulators; Ropivacaine; Lidocaine
• Other Study ID Numbers: 651/12.01.2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Beginning 6 months after primary publication and available for 2 years
• IPD Sharing Access Criteria: Researchers must submit a methodologically sound proposal that is approved by the study's steering committee. Data will be shared via a secure data repository.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No