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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05723341
Enrollment
91
Registered
2023-02-10
Start date
2023-02-15
Completion date
2024-02-01
Last updated
2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Anesthesia, Pain, Postoperative

Keywords

Paravertebral Block, Subcostal Transversus Abdominis Plane Block, Postoperative Controlled Analgesia, Postoperative Pain, Laparoscopic Nephrectomy

Brief summary

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.

Detailed description

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.

Interventions

DRUGBupivacain

%0,25

DRUGMorphine

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

Sponsors

Istanbul University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

RANDOMISED SINGLE BLINDED INTERVENTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative Intravenous Total Morphine ConsumptionUp to 24 hoursThe total dosage of intravenous morphine consumption in 24 hours.

Secondary

MeasureTime frameDescription
Incidence of complications due to the regional blocksUp to first weekIncidence of hematoma, pneumothorax (pleural puncture), local anesthetic toxicity, infection vs.
Chronic postoperative painUp to 90th dayPatients' chronic pain will be assessed by the examiner questioning each patient about the pain status on postoperative 90th day.
Lenght of Hospital StayUp to first weekLenght of Hospital Stay
Postoperative Visual Analog Score (VAS)Up to 24 hoursA 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
Rescue analgesia administration amountsUp to 24 hoursTime of postoperative rescue analgesic requirement time.

Other

MeasureTime frameDescription
Indidence of PONV (postoperative nausea and vomiting)Up to 24 hoursIncidence of postoperative nausea and vomiting
Respiratuar DepressionUp to 24 hoursIncidence of respiratory depression due to iv orphine in the postoperative follow-up.
Postoperative Ramsay Sedation Scale (RSS)Up to 24 hoursRamsay 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.
ItchingUp to 24 hoursIncidence of itching due to iv morphine in the postoperative follow-up.
Surgeon SatisfactionUp to 24 hoursSatisfaction score, 0: very unsatisfied 3: very unsatisfied.
Patient SatisfactionUp to 24 hoursSatisfaction score, 0: very unsatisfied 3: very unsatisfied.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026