AnalgesiaNCT05723341
Comparison of Paravertebral Block and Subcostal Transversus Abdominis Plane Block in Laparoscopic Nephrectomy
A study testing Bupivacain and Morphine in people with Analgesia and Anesthesia, run by Istanbul University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Analgesia, Anesthesia, Pain, Postoperative
- What is being tested?
- Bupivacain and Morphine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Feb 2023to 1 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Postoperative Analgesic Effects of Ultrasonography-Guided Paravertebral Block and Subcostal Transversus Abdominis Plane Block in Patients Undergoing 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.
Read the 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.
- Conditions
- Analgesia, Anesthesia, Pain, Postoperative
- Being tested
- Bupivacain, Morphine
- Keywords
- Paravertebral Block, Subcostal Transversus Abdominis Plane Block, Postoperative Controlled Analgesia, Postoperative Pain, Laparoscopic Nephrectomy
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacainDrug
Also called Marcaine
%0,25
MorphineDrug
Also called Morphine Sulfate
In this group, patients will be postoperatively administered patient-controlled analgesia with morphine only.
| Study group | Role | What they receive |
|---|---|---|
| Paravertebral Block Group | Active comparator | 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. Receives: Drug: Bupivacain; Drug: Morphine |
| Subcostal Transversus Abdominis Plane Block Group | Active comparator | 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 Receives: Drug: Bupivacain; Drug: Morphine |
| Intravenous Patient Controlled Analgesia | Active comparator | In this group, postoperative patient controlled analgesia with morphine will be preferred for postoperative analgesia method. Receives: Drug: Morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Intravenous Total Morphine Consumption
The total dosage of intravenous morphine consumption in 24 hours.
Measured: Up to 24 hours
Secondary outcomes (5)
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
Measured: Up to 24 hours
Rescue analgesia administration amounts
Time of postoperative rescue analgesic requirement time.
Measured: Up to 24 hours
Incidence of complications due to the regional blocks
Incidence of hematoma, pneumothorax (pleural puncture), local anesthetic toxicity, infection vs.
Measured: Up to first week
Chronic postoperative pain
Patients' chronic pain will be assessed by the examiner questioning each patient about the pain status on postoperative 90th day.
Measured: Up to 90th day
Lenght of Hospital Stay
Lenght of Hospital Stay
Measured: Up to first week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start15 Feb 2023
- Primary completion1 Oct 2023
- Study completion1 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AnalgesiaStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- RANDOMISED SINGLE BLINDED INTERVENTIONAL
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meltem Savran Karadeniz, Istanbul University
- Investigators
- Meltem Savran Karadeniz, MD, Principal investigator, Istanbul Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05723341
- Sponsor's protocol ID
- 2022-1276671
- Status last verified
- Mar 2024
- First submitted
- 3 Feb 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 27733219Schwarz 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.
PubMed 8482238Copik 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.
PubMed 28731925Parikh 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.
PubMed 23717232
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Analgesic Effects of Ultrasonography-Guided Paravertebral Block and Subcostal Transversus Abdominis Plane Block in Patients Undergoing Laparoscopic Nephrectomy
- ClinicalTrials.gov ID
- NCT05723341
- Acronym / sponsor ID
- 2022-1276671
- Conditions
- Analgesia, Anesthesia, Pain, Postoperative
- Keywords
- Paravertebral Block, Subcostal Transversus Abdominis Plane Block, Postoperative Controlled Analgesia, Postoperative Pain, Laparoscopic Nephrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- 15 Feb 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Feb 2024 (actual)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- RANDOMISED SINGLE BLINDED INTERVENTIONAL
| Arm | Type | Receives |
|---|---|---|
| Paravertebral Block Group | Active comparator | Drug: Bupivacain, Drug: MorphineIn 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. |
| Subcostal Transversus Abdominis Plane Block Group | Active comparator | Drug: Bupivacain, Drug: MorphineIn 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 |
| Intravenous Patient Controlled Analgesia | Active comparator | Drug: MorphineIn this group, postoperative patient controlled analgesia with morphine will be preferred for postoperative analgesia method. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BupivacainAlso: Marcaine%0,25 | Drug | Paravertebral Block Group, Subcostal Transversus Abdominis Plane Block Group |
| MorphineAlso: Morphine SulfateIn this group, patients will be postoperatively administered patient-controlled analgesia with morphine only. | Drug | Intravenous Patient Controlled Analgesia, Paravertebral Block Group, Subcostal Transversus Abdominis Plane Block Group |
Primary outcome
Postoperative Intravenous Total Morphine Consumption
Time frame: Up to 24 hours
The total dosage of intravenous morphine consumption in 24 hours.
5 secondary outcomes
Postoperative Visual Analog Score (VAS)
Time frame: Up to 24 hours
Rescue analgesia administration amounts
Time frame: Up to 24 hours
Incidence of complications due to the regional blocks
Time frame: Up to first week
Chronic postoperative pain
Time frame: Up to 90th day
Lenght of Hospital Stay
Time frame: Up to first week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Background: PubMed 27733219Qu 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.
- Background: PubMed 8482238Schwarz 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.
- Background: PubMed 28731925Copik 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.
- Background: PubMed 23717232Parikh 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.
- Ultrasound-guided Transversus Abdominis Plane Block Improves Postoperative Analgesia and Early Recovery in Patients Undergoing Retroperitoneoscopic Urologic Surgeries: A Randomized Controlled Double-blinded TrialLink provided by the sponsor.
- Single injection paravertebral block for renal surgery in childrenLink provided by the sponsor.
- Thoracic paravertebral block for postoperative pain management after renal surgery A randomised controlled trialLink provided by the sponsor.
- The analgesic efficacy of ultrasound-guided transversus abdominis plane block for retroperitoneoscopic donor nephrectomy: A randomized controlled studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meltem Savran Karadeniz, MD principal investigator
Istanbul Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacain and Morphine in people with Analgesia and Anesthesia, run by Istanbul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Intravenous Total Morphine Consumption (time frame: Up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05723341, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.