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

NCT ID: NCT05723341

Last Updated: 2024-03-12

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

91 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-15

Study Completion Date

2024-02-01

Brief Summary

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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

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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.

Conditions

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Analgesia Anesthesia Pain, Postoperative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

RANDOMISED SINGLE BLINDED INTERVENTIONAL
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Paravertebral Block Group

In this group, preoperative ultrasound-guided paravertebral block will be performed ipsilateraly via peripheral block needle with 20 ml bupivacaine %0,25 in the paravertebral space.

Group Type ACTIVE_COMPARATOR

Bupivacain

Intervention Type DRUG

%0,25

Morphine

Intervention Type DRUG

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

Subcostal Transversus Abdominis Plane Block Group

In this group, preoperative ultrasound-guided subcostal transversus abdominis plane block will be performed ipsilateraly via peripheral block needle with 20 ml bupivacaine %0,25 into the fascial plane between erector spine muscle and transverse process

Group Type ACTIVE_COMPARATOR

Bupivacain

Intervention Type DRUG

%0,25

Morphine

Intervention Type DRUG

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

Intravenous Patient Controlled Analgesia

In this group, postoperative patient controlled analgesia with morphine will be preferred for postoperative analgesia method.

Group Type ACTIVE_COMPARATOR

Morphine

Intervention Type DRUG

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

Interventions

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Bupivacain

%0,25

Intervention Type DRUG

Morphine

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

Intervention Type DRUG

Other Intervention Names

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Marcaine Morphine Sulfate

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Meltem Savran Karadeniz

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Meltem Savran Karadeniz, MD

Role: PRINCIPAL_INVESTIGATOR

Istanbul Faculty of Medicine

Locations

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Istanbul University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 27733219 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8482238 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28731925 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23717232 (View on PubMed)

Related Links

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https://pubmed.ncbi.nlm.nih.gov/27733219/

Ultrasound-guided Transversus Abdominis Plane Block Improves Postoperative Analgesia and Early Recovery in Patients Undergoing Retroperitoneoscopic Urologic Surgeries: A Randomized Controlled Double-blinded Trial

https://pubmed.ncbi.nlm.nih.gov/18482238/

Single injection paravertebral block for renal surgery in children

https://pubmed.ncbi.nlm.nih.gov/28731925/

Thoracic paravertebral block for postoperative pain management after renal surgery A randomised controlled trial

https://pubmed.ncbi.nlm.nih.gov/23717232/

The analgesic efficacy of ultrasound-guided transversus abdominis plane block for retroperitoneoscopic donor nephrectomy: A randomized controlled study

Other Identifiers

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2022-1276671

Identifier Type: -

Identifier Source: org_study_id

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