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

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05723341
• Other study ID #: 2022-1276671
• Status: Completed
• Phase: N/A
• Start date: February 15, 2023
• Est. completion date: February 1, 2024

Study information

• Verified date: March 2024
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 91
• Est. completion date: February 1, 2024
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Anesthesia
• Pain, Postoperative

Intervention

Drug:
• Bupivacain
%0,25
• Morphine
In this group, patients will be postoperatively administered patient-controlled analgesia with morphine only.

Locations

Country	Name	City	State
Turkey	Istanbul University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Copik M, Bialka S, Daszkiewicz A, Misiolek H. Thoracic paravertebral block for postoperative pain management after renal surgery: A randomised controlled trial. Eur J Anaesthesiol. 2017 Sep;34(9):596-601. doi: 10.1097/EJA.0000000000000673. — View Citation

Parikh BK, Waghmare VT, Shah VR, Mehta T, Butala BP, Parikh GP, Vora KS. The analgesic efficacy of ultrasound-guided transversus abdominis plane block for retroperitoneoscopic donor nephrectomy: A randomized controlled study. Saudi J Anaesth. 2013 Jan;7(1):43-7. doi: 10.4103/1658-354X.109808. — View Citation

Qu G, Cui XL, Liu HJ, Ji ZG, Huang YG. Ultrasound-guided Transversus Abdominis Plane Block Improves Postoperative Analgesia and Early Recovery in Patients Undergoing Retroperitoneoscopic Urologic Surgeries: A Randomized Controlled Double-blinded Trial. Chin Med Sci J. 2016 Sep 20;31(3):137-141. doi: 10.1016/s1001-9294(16)30041-4. — View Citation

Schwarz F, Preusler W, Reifart N, Storger H, Hofmann M, Holscher I. [The long-term success after coronary angioplasty in old age]. Dtsch Med Wochenschr. 1993 Apr 30;118(17):609-14. doi: 10.1055/s-2008-1059369. German. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Indidence of PONV (postoperative nausea and vomiting)	Incidence of postoperative nausea and vomiting	Up to 24 hours
Other	Respiratuar Depression	Incidence of respiratory depression due to iv orphine in the postoperative follow-up.	Up to 24 hours
Other	Postoperative Ramsay Sedation Scale (RSS)	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.	Up to 24 hours
Other	Itching	Incidence of itching due to iv morphine in the postoperative follow-up.	Up to 24 hours
Other	Surgeon Satisfaction	Satisfaction score, 0: very unsatisfied 3: very unsatisfied.	Up to 24 hours
Other	Patient Satisfaction	Satisfaction score, 0: very unsatisfied 3: very unsatisfied.	Up to 24 hours
Primary	Postoperative Intravenous Total Morphine Consumption	The total dosage of intravenous morphine consumption in 24 hours.	Up to 24 hours
Secondary	Postoperative Visual Analog Score (VAS)	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	Up to 24 hours
Secondary	Rescue analgesia administration amounts	Time of postoperative rescue analgesic requirement time.	Up to 24 hours
Secondary	Incidence of complications due to the regional blocks	Incidence of hematoma, pneumothorax (pleural puncture), local anesthetic toxicity, infection vs.	Up to first week
Secondary	Chronic postoperative pain	Patients' chronic pain will be assessed by the examiner questioning each patient about the pain status on postoperative 90th day.	Up to 90th day
Secondary	Lenght of Hospital Stay	Lenght of Hospital Stay	Up to first week

External Links

•   Single injection paravertebral block for renal surgery in children
•   The analgesic efficacy of ultrasound-guided transversus abdominis plane block for retroperitoneoscopic donor nephrectomy: A randomized controlled study
•   Thoracic paravertebral block for postoperative pain management after renal surgery A randomised controlled trial
•   Ultrasound-guided Transversus Abdominis Plane Block Improves Postoperative Analgesia and Early Recovery in Patients Undergoing Retroperitoneoscopic Urologic Surgeries: A Randomized Controlled Double-blinded Trial