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Completed

NCT Number: NCT05723341

Comparison of Paravertebral Block and Subcostal Transversus Abdominis Plane Block in Laparoscopic Nephrectomy

Most of the patients undergoing laparoscopic partial/radical nephrectomy can experience moderate or severe postoperative pain, and inadequate control of this pain can cause negative consequences such as development of chronic pain, pulmonary and cardiac events, and side effects of long term opioid usage. Due to these adverse outcomes, ultrasonography-guided plane blocks can be beneficial for these patients to decrease opioid consumption. In this study, the investigators aim to compare ultrasonography-guided plane blocks: Paravertebral block and subcostal transversus abdominis plane block and traditional method: patient controlled analgesia with opioids. The investigators hypothesized that analgesic efficacy in both paravertebral and subcostal TAP blocks will have similar outcomes but better than traditional method.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul University

Istanbul, Turkey (Türkiye)

About this study

More than half of patients undergoing laparoscopic partial/radical nephrectomy develop moderate or severe postoperative pain. Inadequate control of postoperative pain may delay early mobilization and rehabilitation, increase pulmonary and thromboembolic events, prolong hospital stay, and decrease patient satisfaction. Inadequate postoperative pain control may lead to the development of chronic pain, resulting in long-term opioid use. In the traditional analgesia model provided with opioids, patients may develop side effects such as nausea, vomiting, hypotension, loss of consciousness, and respiratory depression. For this reason, it would be more rational to provide analgesia with regional methods, which are decided according to the suitability of the patient and the surgical procedure, rather than the use of intravenous drugs. Ultrasonography-guided plane blocks, one of the main elements of multimodal analgesia, are used more frequently with the introduction of ultrasonography into daily practice. These blocks are frequently preferred in daily practice as they reduce opioid consumption by providing effective postoperative analgesia with low complication rates and ease of application.

In the ultrasonography-guided paravertebral block, local anesthetic is injected into the triangle constituted by superior costotransvers ligament, parietal pleura and vertebral body where the spinal nerves emerge from the intervertebral foramen. Ipsilateral somatic and sympathetic nerve blockade is observed. It is a body block that can be used to provide both analgesia and anesthesia. Paravertebral block provides successful postoperative analgesia, reduces the decline in postoperative respiratory function, accelerates the recovery of respiratory mechanics, and reduces postoperative vomiting, allowing earlier initiation of oral intake.

Ultrasonography-guided subcostal transversus abdominis plane block is a relatively safe and simple body block in which local anesthetic is injected into the fascial plane located between posterior rectus sheath and transversus abdominis muscle. The transversus abdominis plane is the fascial plane superficial to the transversus abdominis muscle, the innermost muscular layer of the anterolateral abdominal wall. The subcostal transversus abdominis plane block ideally anesthetizes the intercostal nerves T6-T9 between the rectus abdominis sheath and the transversus abdominis muscle. It is a truncal block that has drawn attention recently, both because it is easier to apply and because it is a more peripheral block.

In this study the investigators aim to compare the effects of two truncal blocks on postoperative pain, morphine consumption, chronic pain and complications.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age of 18-75
  • Patients who are ASA (American Society of Anesthesiology): I-II
  • Patients who will have laparoscopic partial/radical nephrectomy
  • Patients who volunteer to participate in the study

Exclusion criteria

  • Patients with any kind of coagulopathy
  • Patients with severe cardiac, pulmonary, renal or liver disease
  • Patients who have difficulty comprehending the IV PCA device
  • Patients with local anesthetic allergy
  • Patients with chronic opioid use

Treatment and study plan

Bupivacain

Drug

%0,25

Other names: Marcaine

Morphine

Drug

In this group, patients will be postoperatively administered patient-controlled analgesia with morphine only.

Other names: Morphine Sulfate

Primary outcomes

  1. Postoperative Intravenous Total Morphine Consumption

    Time frame: Up to 24 hours

    The total dosage of intravenous morphine consumption in 24 hours.

Secondary outcomes

  1. Postoperative Visual Analog Score (VAS)

    Time frame: Up to 24 hours

    A visual analog score (VAS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable

  2. Rescue analgesia administration amounts

    Time frame: Up to 24 hours

    Time of postoperative rescue analgesic requirement time.

  3. Incidence of complications due to the regional blocks

    Time frame: Up to first week

    Incidence of hematoma, pneumothorax (pleural puncture), local anesthetic toxicity, infection vs.

  4. Chronic postoperative pain

    Time frame: Up to 90th day

    Patients' chronic pain will be assessed by the examiner questioning each patient about the pain status on postoperative 90th day.

  5. Lenght of Hospital Stay

    Time frame: Up to first week

    Lenght of Hospital Stay

Other outcomes

  1. Indidence of PONV (postoperative nausea and vomiting)

    Time frame: Up to 24 hours

    Incidence of postoperative nausea and vomiting

  2. Respiratuar Depression

    Time frame: Up to 24 hours

    Incidence of respiratory depression due to iv orphine in the postoperative follow-up.

  3. Postoperative Ramsay Sedation Scale (RSS)

    Time frame: Up to 24 hours

    Ramsay sedation scale requires the patient to rate their sedation on a defined scale. For example, 1: anxious and agitated or restless, or both 2: cooperative, oriented and tranquil 3: responds to commands only 4: brisk response to stimulus 5: sluggish response to stimulus 6: no response to stimulus.

  4. Itching

    Time frame: Up to 24 hours

    Incidence of itching due to iv morphine in the postoperative follow-up.

  5. Surgeon Satisfaction

    Time frame: Up to 24 hours

    Satisfaction score, 0: very unsatisfied 3: very unsatisfied.

  6. Patient Satisfaction

    Time frame: Up to 24 hours

    Satisfaction score, 0: very unsatisfied 3: very unsatisfied.

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Comparison of Postoperative Analgesic Effects of Ultrasonography-Guided Paravertebral Block and Subcostal Transversus Abdominis Plane Block in Patients Undergoing Laparoscopic Nephrectomy

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Feb 10, 2023
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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