Subcostal Approach to Anterior Quadratus Block Versus Thoracic Paravertebral Block for Laparoscopic Nephrectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-01

Study Completion Date

2023-02-01

Brief Summary

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In this study, it was aimed to evaluate the effects of subcostal anterior quadratus lumborum block (S-QLB3) and thoracic paravertebral block (TPVB) on postoperative acute pain scores and opioid consumption in the first 24 hours after laparoscopic nephrectomy surgery.

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Detailed Description

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Laparoscopic partial or radical nephrectomy is associated with severe acute postoperative pain. Acute pain is mediated by inflammation, activation of spinal pathways and muscle spasm. Poor pain control may reduce patient satisfaction, delay postoperative ambulation and increase the incidence of pulmonary and cardiac complications.

Facial plane blocks, an important element of multimodal analgesia, can reduce the dosage of opioids, minimize side effects and improve the quality of postoperative recovery. Quadratus lumborum (QL) block is a relatively new technique. Subcostal anterior QL block (S-QLB3) involves injection in the plane between the psoas and QL muscles. Thoracic paravertebral block (TPVB) is frequently used in thoracic and general surgery and its significant analgesic efficacy has been demonstrated in the literature. It has been used successfully as part of multimodal analgesia in renal surgery.

In this study, it was aimed to evaluate the effects of S-QLB3 block and TPVB block on pain scores and opioid consumption in patients undergoing laparoscopic nephrectomy.

Patients will be divided into two groups:

Group S-QLB3:A unilateral S-QLB3 block will be performed (0.4 ml/kg of 0.25% bupivacaine + 1:400.000 adrenaline). In addition, IV morphine-PCA will be applied postoperatively for 24 hours.

Group TPVB: A unilateral TPV block will be performed (0.4 ml/kg of 0.25% bupivacaine + 1:400,000 adrenaline). In addition, IV morphine-PCA will be applied postoperatively for 24 hours.

Conditions

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Anesthesia Analgesia Acute Pain Patient Controlled Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A block randomization list will be created by a doctor who does not participate in patient follow-up using a web-based program, 'Research Randomizer (Urbaniak and Plous 2013)'.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Sealed opaque envelopes containing study participation numbers will be used to assign each patient. A researcher not involved in patient follow-up will use the web-based "Research Randomizer" (Urbaniak and Plous 2013) tool to give each participation number to a random group with a 1:1 ratio.

A nurse not an active investigator in the study will have each participant choose an envelope containing the study participation number. They will inform the anesthetist who will administer the block/blocks about which group the patient is in immediately before administration. Researchers, patients, surgeons, and nurses will not be aware of the randomization of groups.

Study Groups

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Group S-QLB3

S-QLB3 block (0.4 ml/kg of 0.25% bupivacaine + 1:400.000 adrenaline) + iv morphine-PCA

Group Type ACTIVE_COMPARATOR

Subcostal Anterior Quadratus Lumborum Block

Intervention Type PROCEDURE

S-QLB3 block will be performed 30 min. before general anesthesia. For anterior QL block via subcostal approach, 0.4 ml/kg of 0.25% bupivacaine + 1:400.000 adrenaline will be injected into the interfacial plane between the QLM and PMM.

IV-PCA: The requested dose will be 20µg/kg morphine, the lock-in time will be 6-10 minutes, the 4-hour limit will be 80% of the total calculated dose.

Group TPVB

TPVB block (0.4 ml/kg of 0.25% bupivacaine + 1:400.000 adrenaline) + iv morphine-PCA

Group Type ACTIVE_COMPARATOR

Thoracic Paravertebral Block

Intervention Type PROCEDURE

TPVB block will be performed 30 min. before general anesthesia. TPVB will be performed at T10 transverse process level, 0.4 ml/kg of 0.25% bupivacaine + 1:400.000 adrenaline will be injected into the paravertebral space.

IV-PCA: The requested dose will be 20µg/kg morphine, the lock-in time will be 6-10 minutes, the 4-hour limit will be 80% of the total calculated dose.

Interventions

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Subcostal Anterior Quadratus Lumborum Block

S-QLB3 block will be performed 30 min. before general anesthesia. For anterior QL block via subcostal approach, 0.4 ml/kg of 0.25% bupivacaine + 1:400.000 adrenaline will be injected into the interfacial plane between the QLM and PMM.

IV-PCA: The requested dose will be 20µg/kg morphine, the lock-in time will be 6-10 minutes, the 4-hour limit will be 80% of the total calculated dose.

Intervention Type PROCEDURE

Thoracic Paravertebral Block

TPVB block will be performed 30 min. before general anesthesia. TPVB will be performed at T10 transverse process level, 0.4 ml/kg of 0.25% bupivacaine + 1:400.000 adrenaline will be injected into the paravertebral space.

IV-PCA: The requested dose will be 20µg/kg morphine, the lock-in time will be 6-10 minutes, the 4-hour limit will be 80% of the total calculated dose.

Intervention Type PROCEDURE

Other Intervention Names

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S-QLB3 TPVB

Eligibility Criteria

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Inclusion Criteria

* ASA I-II patients aged 18-70 y, scheduled for elective laparoscopic unilateral nephrectomy(partial/radical)

Exclusion Criteria

* Age \<18y, \>70y
* Obesity (BMI\> 30 kg / m2)
* Pregnancy
* Contraindication of regional anesthesia (coagulopathy, abnormal INR, thrombocytopenia, infection at the injection site)
* Serious cardiac, hepatic, and cerebrovascular disease
* Hypersensitivity to local anesthetics or a history of allergy
* Patients with a history of opioid use longer than four weeks
* Patients with psychiatric disorders or communication difficulties
* Patients who do not want to participate
* Asthma/chronic obstructive pulmonary disease, chronic pain syndrome, substance use disorder, or sleep apnea

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No