Clinical trial NCT05723341: Comparison of Paravertebral Block and Subcostal Transversus Abdominis Plane Block in Laparoscopic Nephrectomy
Official title: Comparison of Postoperative Analgesic Effects of Ultrasonography-Guided Paravertebral Block and Subcostal Transversus Abdominis Plane Block in Patients Undergoing Laparoscopic Nephrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Analgesia
Anesthesia
Pain, Postoperative
Keywords: Paravertebral Block
Subcostal Transversus Abdominis Plane Block
Postoperative Controlled Analgesia
Postoperative Pain
Laparoscopic Nephrectomy
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2023-02-10
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RANDOMISED SINGLE BLINDED INTERVENTIONAL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Intravenous Total Morphine Consumption
timeFrame: Up to 24 hours
Secondary outcomes:
measure: Postoperative Visual Analog Score (VAS)
timeFrame: Up to 24 hours
measure: Rescue analgesia administration amounts
timeFrame: Up to 24 hours
measure: Incidence of complications due to the regional blocks
timeFrame: Up to first week
measure: Chronic postoperative pain
timeFrame: Up to 90th day
measure: Lenght of Hospital Stay
timeFrame: Up to first week
Other outcomes:
measure: Indidence of PONV (postoperative nausea and vomiting)
timeFrame: Up to 24 hours
measure: Respiratuar Depression
timeFrame: Up to 24 hours
measure: Postoperative Ramsay Sedation Scale (RSS)
timeFrame: Up to 24 hours
measure: Itching
timeFrame: Up to 24 hours
measure: Surgeon Satisfaction
timeFrame: Up to 24 hours
measure: Patient Satisfaction
timeFrame: Up to 24 hours
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University
Study officials:
affiliation: Istanbul Faculty of Medicine
name: Meltem Savran Karadeniz, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.
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.