Analgesic Efficacy of Plan Blocks in Laparoscopic Hysterectomies

February 3, 2025 updated by: Nazan KOCAOGLU, MD, Balikesir University

Effects of Ultrasonography-Guided Plan Blocks (ESP&OSTAP) on Perioperative Analgesia in Laparoscopic Hysterectomies

Hysterectomy is the most common major intervention in gynecology after cesarean section. Indications include myoma uteri, abnormal uterine bleeding, cervical intraepithelial neoplasia, chronic pelvic pain, uterine uteri, operated breast cancer, and endometrial hyperplasia. Today, hysterectomy can be performed abdominally, vaginally and laparoscopically.¹ Laparoscopic hysterectomy (LH) has several advantages and disadvantages compared to other forms of hysterectomy. Shorter recovery time, less wound infection, shorter hospital stay, and less need for postoperative analgesia can be counted among the advantages. The prolongation of the operation time and the increased risk of urinary complications are disadvantages.² Postoperative pain management can be done with different methods depending on the location of the surgical field, the type of surgical procedure, the patient's need for analgesia, and patient preference. These methods include oral, intravenous or intramuscular medication and nerve blocks. In order to minimize the side effects of opioids used in analgesic therapy such as respiratory depression, nausea-vomiting, lethargy, constipation and itching, and to increase the analgesic effect, the "balanced analgesia" method is used.⁴ With this method, opioids, non-opioid analgesics or peripheral nerve-field blocks side effects are minimized and optimum analgesia is provided.

Transversus abdominis plane (TAP) block, which is one of the abdominal field blocks, was first described by Rafi in 2001.⁶ Hebbard et al. stated in 2007 that ultrasonography (USG)-guided TAP block can be applied more effectively and safely.⁷ This block can be applied more effectively and safely.⁷ This block is antero-lateral, posterior, and oblique It can be done subcostal with three different approaches. TAP block has been shown to reduce postoperative pain after hysterectomy, cesarean section, and colorectal surgery.⁸ Erector spina plane (ESP) block was first described by Forero et al. in 2016 on a patient with chronic neuropathic pain.⁹ The basic technique is performed paraspinally under USG guidance. It is used for postoperative analgesia in breast, thoracic surgeries, hernia repair, dorsal colon, abdomen and hip surgery.

In this study, it is aimed to compare the effects of USG-guided ESP block and OSTAP block applications on perioperative pain control in total laparoscopic hysterectomy operations.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

MATERIAL AND METHOD Patients between the ages of 18-65, ASA I-II, BMI ≤30 kg/m2 who will undergo elective surgery under general anesthesia, with voluntary consent will be included in the study. Patients with local anesthetic allergy, coagulopathy, infection at the block application site, and mental deficiency and for whom the surgical plan has been changed (complicated/open surgery) will be excluded from the study.

Patients included in the study will be informed about patient-controlled analgesia (PCA) and numerical rating scale (NRS: Numeric Rating Scale) for the assessment of pain severity before the operation. Demographic data of the patients will be recorded.

Anesthesia Application:

After the intravenous (IV) route is provided with a 20 G cannula in the preoperative preparation room, 10 mL/kg of balanced crystalloid fluid infusion will be started. 0.03 mg/kg midazolam will be administered for premedication. Standard monitoring (ECG, heart rate, non-invasive blood pressure, SPO2, temperature) and neuromuscular monitoring will be applied to all patients. The input value of these parameters will be saved before induction. Records will be taken at 5-minute intervals until the end of the operation. For induction of anesthesia, 2 mg/kg propofol, 1μg/kg remifentanil will be administered as an IV bolus within 60 seconds. Analgesia maintenance will be provided with 0.05-0.25 μg/kg/min remifentanil infusion. Muscle relaxation will be provided with IV 0.6 mg/kg rocuronium. He will be intubated orotracheally when his train of four rate (TOFR) response is zero. (In case of neuromuscular blocker requirement, IV 0.01 mg/kg rocuronium will be additionally administered.) Anesthesia is maintained with 0.5 L/min fresh gas flow, oxygen concentration with inspiratory oxygen level between 40-45, minimum alveolar concentration (MAC) with 0.9-1.1 with sevoflurane. will be applied. Mechanical ventilation will be performed with Volume AutoFlow mod (V-AF) with ETCO2 between 35-40 mmHg.

Patients will be randomly divided into two groups after induction. Group ESP (I): The group to which Erector Spina Plan Block (ESP) will be administered Group OSTAP (II): The group to which Oblique Subcostal Transversus Abdominis Plan Block (OSTAP) will be applied In the study, anesthesia induction and plan blocks will be performed by the same anesthesiologist. Intraoperative and postoperative data recording and patient evaluation will be done by two separate anesthesiologists.

ESP Block Application:

In the lateral decubitus position after induction, in accordance with the rules of asepsis-antisepsis, USG (Sonosite M-Turbo) machine, linear 6-13 mHz probe will be placed approximately 3 cm lateral to the T9 spinous process in the sagittal plane and with an in-plane approach, the hyperechoic shadow of the transverse process and the erector spina muscle ( Once the ESM) has been identified, a 22 G, 80 mm Stimuplex® Ultra 360® (B.Braun, Melsungen, Germany) needle will be inserted in the cephalocaudal direction to gently contact the T9 spinous process over the erector spinae. After negative pressure aspiration between the transverse process and ECM, 1-2 mL of local anesthetic will be injected, and after cephalocaudal spread is observed, a total of 20 mL of 0.25 mg/mL bupivacaine will be given by intermittent aspiration every 4-5 mL. The same procedure will be applied to the other side.

OSTAP Block Application:

After the induction, in the supine position, in accordance with the rules of asepsis-antisepsis, the USG (Sonosite M-Turbo) machine will be placed on the anterior axillary line, the linear 6-13 mHz probe will be placed on the subcostal lower edge between the xiphoid and the anterosuperior iliac process, and the rectus abdominis and transversus abdominis muscles will be visualized. Then, 22 G, 80 mm Stimuplex®Ultra 360® (B.Braun, Melsungen, Germany) needle is directed in-plane from 2-3 cm medial of the rectus abdominis muscle, negative pressure aspiration between the transversus abdominis and rectus abdominis muscles is applied 1-2 mL of local anesthetic will be injected. After local anesthetic spread is observed, a total of 20 mL of 0.25 mg/mL bupivacaine will be given by intermittent aspiration every 4-5 mL. The same procedure will be applied to the other side.

Surgical incision will be made 15 minutes after block applications. Patients will undergo standard surgical procedures. The patients will be operated in the 45⁰ trendelenburg position and the pneumoperitoneum pressure is 10-12 mmHg. In case of (±) 15% change in the hemodynamic parameters of the patient compared to the initial values, the remifentanil infusion dose will be increased or decreased at the specified intervals and the amount consumed intraoperatively at the end of the operation will be recorded. It will be defined as hypotension when the systolic arterial pressure decreases by 30% from the baseline value. In the treatment, 250 mL of 0.9% NaCl will be rapidly infused first. If there is no response, 10 mg of ephedrine will be given IV. When bradycardia occurs (heart rate <50 beats/min) IV 0.5 mg of atropine will be administered. The time from the skin incision to the end of the surgical procedure will be recorded as "Operation Time".

Sevoflurane flow and remifentanil infusion will be terminated 15 minutes before the end of the operation. Patients will be administered 50 mg dexketoprofen trometamol IV and 1 g paracetamol IV infusion. At the end of the operation, the fresh gas flow will be increased to 8 L/min. To end the neuromuscular blockade, 4 mg/kg of sugammadex will be administered IV. When the TOFR is 0.9, he will be extubated and transferred to the postoperative recovery unit (PACU). The time between termination of sevoflurane flow and extubation will be recorded as "Extubation time", and the time between anesthesia induction and extubation will be recorded as "Anesthesia Time".

Patient-controlled analgesia (PCA) and morphine infusion will be administered to both groups of patients in the PACU.

Morphine protocol: It will be prepared as 1 mg/mL with 5 mL Morphine Sulphate (50mg) + 45 mL physiological saline. It will be administered as an intermittent bolus of 1 mg, without basal infusion, with a 20-minute lock-in time.

Postoperative pain intensity, sedation level and nausea-vomiting score of the patients at rest and movement status will be evaluated at 0, 2, 4, 6, 12 and 24 hours by an anesthesiologist who is not familiar with the study groups.

The severity of pain will be evaluated with NRS at rest and in motion (0: No pain 1 2 3 4 5 6 7 8 9 10: Unbearable pain) If NRS≥4, dexketoprofen trometamol 50 mg IV will be administered as a rescue analgesic.

The Observer's Assessment of the Alertness/Sedation (OAA/S) will be used to monitor the sedation level of the patient.

Nausea will be measured with 4 categorical scoring systems (No nausea: 0, Mild: 1, Moderate: 2, Severe: 3) For the treatment of nausea-vomiting, 4mg ondansetron will be administered IV. Patients with a modified Aldrete score ≥9 will be discharged to the ward. The time elapsed between the patient's admission to the PACU and discharge to the service will be recorded as "Recovery Time".

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Balıkesir, Turkey, 10145
        • Balikesir University
      • Balıkesir, Turkey
        • Medical faculty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Between 18-65 years laparoscopic hysterectomy under general anesthesia ASA I-II BMI ≤30 kg/m2

Exclusion Criteria:

local anesthetic allergy coagulopathy infection at the block application site mental deficiency the surgical plan has been changed (complicated/open surgery)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Grup ESP
The group to which erector spina plane block will be applied
Procedure: Plane block
Plane block application in laparoscopic hysterectomies
Active Comparator: Grup OSTAP
The group to which oblique subcostal transversus abdominis plane block will be applied
Procedure: Plane block
Plane block application in laparoscopic hysterectomies

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Plane blocks
Time Frame: Intraoperative and postoperative first 24 hours
Analgesic efficacy between ESP and OSTAP blocks will be evaluated by Numeric Rating Scale. Intraoperative and postoperative opioid consumption will be compared.
Intraoperative and postoperative first 24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Nausea
Time Frame: Intraoperative and postoperative first 24 hours
Nausea, vomiting and other side effects will be evaluated
Intraoperative and postoperative first 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Balikesir University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nazan Kocaoglu, Balikesir University Medical Faculty

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 6, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 15, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 14, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 22, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DT/2022-04-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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