PainPhase 2/3NCT02707250
Oblique Subcostal Tap Block Efficacy in Laparoscopic Cholecystectomy
A Phase 2/3 study testing Bupivacaine, Pethidine and Pethidine Local Infiltration (L.I) in people with Pain, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
Trial summary
Laparoscopic cholecystectomy although a minimally invasive procedure, may be accompanied by considerable pain after surgery. More recently transversus abdominis plane (TAP) block was extensively studied as a potential analgesic maneuver after laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain
- What is being tested?
- Bupivacaine, Pethidine and Pethidine Local Infiltration (L.I)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteRomania
- Study dates
- Mar 2015to Jun 2016
- Phase
- Phase 2/3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anaesthesiologists (ASA) I-II
- Age over 18years old
- patients scheduled elective laparoscopic cholecystectomy
Who cannot join
- Open cholecystectomy - excluded due to increased levels of pain in open procedures
- Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and pain medications
- Coagulopathy or anticoagulation - increased risk of bleeding from nerve block injection
- Allergy or contraindication to any of the study medications or anesthetic agents
- Chronic opioid analgesic use at home - excluded due to potential difficulty in assessing pain caused by the procedure alone
- Patient inability to properly describe postoperative pain to investigators (language barrier, dementia, delirium, psychiatric disorder)
Show all 9Show fewer
- Pregnancy
- Prisoners
- Patient or surgeon refusal
Trial locations and contacts
1 site in 1 country.
Romania1 site, 1 recruiting
- Recruiting
Regional Institute of Gastroenterology and Hepatology "Prof.dr.Octavian Fodor"
Cluj-Napoca, Cluj, 400162
Caius M Breazu, MD, 0040743010012, csbreazu@yahoo.com
Caius M Breazu, MD
About this study
Official title: Oblique Subcostal Transverses Abdominal Plane Block in Laparoscopic Cholecystectomy
Laparoscopic cholecystectomy although a minimally invasive procedure, may be accompanied by considerable pain after surgery. More recently transversus abdominis plane (TAP) block was extensively studied as a potential analgesic maneuver after laparoscopic cholecystectomy. The subcostal approach (OSTAP block) is a variation on the TAP block that produces reliable supraumbilical analgesia.
Read the detailed description
Laparoscopic cholecystectomy is a minimally invasive widespread surgical procedure, with postoperative lower pain scores and quick recovery of the patient. However some of patients may complain of considerable pain after surgery . There are several approaches to postoperative pain management after laparoscopic cholecystectomy such as patient-controlled analgesia with opioids (IV-PCA), neuraxial blocks, intraperitoneal injection of local anesthetics, wound infiltration, each being more or less effective, with specific side effects.
The transversus abdominis plane block (TAP-Block) is a regional analgesia technique that comes as an alternative to "classical" procedures of postoperative analgesia. Described by Rafi and McDonnell et al. this technique has undergone some changes over times, which increased its efficiency. Thus, Hebbard et al. described ultrasound subcostal oblique approach (OSTAP) of the block allowing analgesia in both the upper and lower abdomen, with a lower rate of complications due to the direct ultrasound visualization. Different studies confirmed the analgesic efficacy of this technique and the postoperative opioid sparing effect after laparoscopic cholecystectomy .
Traditionally, the transversus abdominis plane block is achieved with classical amino-amides local anesthetics, bupivacaine, levobupivacaine and ropivacaine being the most commonly used .
Based on the local anesthetic properties of pethidine, a synthetic opioid, our study aimed to evaluate prospectively the analgesic efficacy of pethidine in achieving transversus abdominis plane block by ultrasound oblique subcostal approach in patients scheduled for elective laparoscopic cholecystectomy.
- Conditions
- Pain
- Being tested
- Placebo, Bupivacaine, Pethidine, Pethidine Local Infiltration (L.I)
- Keywords
- pethidine, laparoscopic cholecystectomy, bupivacaine
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Tap Block Placebo
Tap Block performed with normal sterile saline 20 ml on the right side and 20 ml on the left side
BupivacaineDrug
Also called Tap Block Bupivacaine
Tap Block performed with Bupivacaine 0,25% 20 ml on the right side and 20 ml on the left side.
PethidineDrug
Also called Tap Block Pethidine
Tap Block performed with pethidine 1% 10 ml on the right side and 10 ml on the left side
Pethidine Local Infiltration (L.I)Drug
Also called Pethidine Local Infiltration
Local infiltration of port sites (trocar insertion sites) with pethidine 1% 5ml each port (trocar site) ,4 ports total 20 ml pethidine 1%
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Oblique subcostal tap block with normal sterile saline ,20 ml, bilateral, single shot,24h Receives: Drug: Placebo |
| Bupivacaine | Active comparator | Oblique subcostal tap block with bupivacaine 0,25% ,20 ml, bilateral, single shot,24h Receives: Drug: Bupivacaine |
| Pethidine | Active comparator | Oblique subcostal tap block with pethidine 1% ,10 ml,bilateral,single shot,24h Receives: Drug: Pethidine |
| Pethidine Local Infiltration (L.I.) | Active comparator | Local infiltration of pethidine 1% at trocar insertion sites, 5ml /site, 24h compared with Tap Block with pethidine 1% Receives: Drug: Pethidine Local Infiltration (L.I) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores
This outcome is measured with a visual analogue scale (VAS, from 0 to 10) at 2 hours postoperative, while the patient is in his bed. This outcome is recorded in and compared between all four groups.
Measured: Recorded 2 hours postoperative
Pain Scores
This outcome is measured with a visual analogue scale (VAS, from 0 to 10) at 6 hours postoperative, while the patient is in his bed. This outcome is recorded in and compared between all four groups.
Measured: Recorded 6 hours postoperative
Pain Scores
This outcome is measured with a visual analogue scale (VAS, from 0 to 10) at 12 hours postoperative, while the patient is in his bed. This outcome is recorded in and compared between all four groups.
Measured: Recorded 12 hours postoperative
Pain Scores
This outcome is measured with a visual analogue scale (VAS, from 0 to 10) at 24 hours postoperative, while the patient is in his bed. This outcome is recorded in and compared between all four groups.
Measured: Recorded 24 hours postoperative
Secondary outcomes (4)
Intraoperative fentanyl consumption
Recording total amount of intraoperative fentanyl consumption
Measured: 0-4 hours
Time to first opioid administration in Post Anesthetic Care Unit
Recording time to first opioid administration in post aesthetic care unit
Measured: 0-4 hours postoperative
Cumulative opioid consumption
Recording total amount of opioids used in postoperative period
Measured: Recorded in the first 24 hours perioperative period
Side effects
nausea, vomiting, pruritus and sedation on a 4 point scale as none, mild, moderate and severe
Measured: Recorded in the first 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study startMar 2015
- Primary completionFeb 2016
- Study completionJun 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Iuliu Hatieganu University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Breazu Caius Mihai, Iuliu Hatieganu University of Medicine and Pharmacy
- Investigators
- Daniela Ionescu, MD, Study director, University of Medicine and Pharmacy "Iuliu Hatieganu" Cluj-Napoca,Romania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707250
- Sponsor's protocol ID
- IuliuHatieganuU
- Status last verified
- Mar 2016
- First submitted
- 19 Feb 2016
- Last updated
- 14 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Breazu C, Margarit S, Bartos A, Ionescu D. Postoperative Analgesia after Laparoscopic Cholecystectomy - Prospective, Randomized, Double Blind, Control Trial. Chirurgia (Bucur). 2022 Oct;117(5):563-571. doi: 10.21614/chirurgia.2769.
PubMed 36318686
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oblique Subcostal Transverses Abdominal Plane Block in Laparoscopic Cholecystectomy
- ClinicalTrials.gov ID
- NCT02707250
- Acronym / sponsor ID
- IuliuHatieganuU
- Conditions
- Pain
- Keywords
- pethidine, laparoscopic cholecystectomy, bupivacaine
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Iuliu Hatieganu University of Medicine and PharmacyUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Jun 2016 (estimated)
- First posted
- 14 Mar 2016 (estimated)
- 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.
Laparoscopic cholecystectomy although a minimally invasive procedure, may be accompanied by considerable pain after surgery. More recently transversus abdominis plane (TAP) block was extensively studied as a potential analgesic maneuver after laparoscopic cholecystectomy. The subcostal approach (OSTAP block) is a variation on the TAP block that produces reliable supraumbilical analgesia.
Detailed description
Laparoscopic cholecystectomy is a minimally invasive widespread surgical procedure, with postoperative lower pain scores and quick recovery of the patient. However some of patients may complain of considerable pain after surgery . There are several approaches to postoperative pain management after laparoscopic cholecystectomy such as patient-controlled analgesia with opioids (IV-PCA), neuraxial blocks, intraperitoneal injection of local anesthetics, wound infiltration, each being more or less effective, with specific side effects.
The transversus abdominis plane block (TAP-Block) is a regional analgesia technique that comes as an alternative to "classical" procedures of postoperative analgesia. Described by Rafi and McDonnell et al. this technique has undergone some changes over times, which increased its efficiency. Thus, Hebbard et al. described ultrasound subcostal oblique approach (OSTAP) of the block allowing analgesia in both the upper and lower abdomen, with a lower rate of complications due to the direct ultrasound visualization. Different studies confirmed the analgesic efficacy of this technique and the postoperative opioid sparing effect after laparoscopic cholecystectomy .
Traditionally, the transversus abdominis plane block is achieved with classical amino-amides local anesthetics, bupivacaine, levobupivacaine and ropivacaine being the most commonly used .
Based on the local anesthetic properties of pethidine, a synthetic opioid, our study aimed to evaluate prospectively the analgesic efficacy of pethidine in achieving transversus abdominis plane block by ultrasound oblique subcostal approach in patients scheduled for elective laparoscopic cholecystectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboOblique subcostal tap block with normal sterile saline ,20 ml, bilateral, single shot,24h |
| Bupivacaine | Active comparator | Drug: BupivacaineOblique subcostal tap block with bupivacaine 0,25% ,20 ml, bilateral, single shot,24h |
| Pethidine | Active comparator | Drug: PethidineOblique subcostal tap block with pethidine 1% ,10 ml,bilateral,single shot,24h |
| Pethidine Local Infiltration (L.I.) | Active comparator | Drug: Pethidine Local Infiltration (L.I)Local infiltration of pethidine 1% at trocar insertion sites, 5ml /site, 24h compared with Tap Block with pethidine 1% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- American Society of Anaesthesiologists (ASA) I-II
- Age over 18years old
- patients scheduled elective laparoscopic cholecystectomy
Key exclusion criteria (9 listed)
- Open cholecystectomy - excluded due to increased levels of pain in open procedures
- Renal dysfunction (Serum Cr > 1.2) - excluded due to potential altered metabolism of anesthetic and pain medications
- Coagulopathy or anticoagulation - increased risk of bleeding from nerve block injection
- Allergy or contraindication to any of the study medications or anesthetic agents
- Chronic opioid analgesic use at home - excluded due to potential difficulty in assessing pain caused by the procedure alone
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 |
|---|---|---|
| PlaceboAlso: Tap Block PlaceboTap Block performed with normal sterile saline 20 ml on the right side and 20 ml on the left side | Drug | Placebo |
| BupivacaineAlso: Tap Block BupivacaineTap Block performed with Bupivacaine 0,25% 20 ml on the right side and 20 ml on the left side. | Drug | Bupivacaine |
| PethidineAlso: Tap Block PethidineTap Block performed with pethidine 1% 10 ml on the right side and 10 ml on the left side | Drug | Pethidine |
| Pethidine Local Infiltration (L.I)Also: Pethidine Local InfiltrationLocal infiltration of port sites (trocar insertion sites) with pethidine 1% 5ml each port (trocar site) ,4 ports total 20 ml pethidine 1% | Drug | Pethidine Local Infiltration (L.I.) |
Primary outcome
Pain Scores
Time frame: Recorded 2 hours postoperative
This outcome is measured with a visual analogue scale (VAS, from 0 to 10) at 2 hours postoperative, while the patient is in his bed. This outcome is recorded in and compared between all four groups.
Pain Scores
Time frame: Recorded 6 hours postoperative
This outcome is measured with a visual analogue scale (VAS, from 0 to 10) at 6 hours postoperative, while the patient is in his bed. This outcome is recorded in and compared between all four groups.
Pain Scores
Time frame: Recorded 12 hours postoperative
This outcome is measured with a visual analogue scale (VAS, from 0 to 10) at 12 hours postoperative, while the patient is in his bed. This outcome is recorded in and compared between all four groups.
Pain Scores
Time frame: Recorded 24 hours postoperative
This outcome is measured with a visual analogue scale (VAS, from 0 to 10) at 24 hours postoperative, while the patient is in his bed. This outcome is recorded in and compared between all four groups.
4 secondary outcomes
Intraoperative fentanyl consumption
Time frame: 0-4 hours
Time to first opioid administration in Post Anesthetic Care Unit
Time frame: 0-4 hours postoperative
Cumulative opioid consumption
Time frame: Recorded in the first 24 hours perioperative period
Side effects
Time frame: Recorded in the first 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
- Derived from this study: PubMed 36318686Breazu C, Margarit S, Bartos A, Ionescu D. Postoperative Analgesia after Laparoscopic Cholecystectomy - Prospective, Randomized, Double Blind, Control Trial. Chirurgia (Bucur). 2022 Oct;117(5):563-571. doi: 10.21614/chirurgia.2769.
- Individual participant dataSharing planned: Undecided
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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.
Daniela Ionescu, MD study director
University of Medicine and Pharmacy "Iuliu Hatieganu" Cluj-Napoca,Romania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Bupivacaine, Pethidine and Pethidine Local Infiltration (L.I) in people with Pain, run by Iuliu Hatieganu University of Medicine and Pharmacy at 1 site in Romania.
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 3 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 14 Mar 2016. 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 Romania. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Caius M Breazu, MD (+40743010012, csbreazu@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores (time frame: Recorded 2 hours postoperative). The study lists 4 primary outcomes in all. 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 NCT02707250, which also lists 1 linked publication.
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 14 Mar 2016.