Pain, PostoperativePhase 4NCT02969187
Bupivacaine Liposomal Injection (Exparel) for Postsurgical Analgesia in Patient Undergoing Laparoscopic Bariatric Surgery
A Phase 4 study testing Exparel, Bupivacain and Saline in people with Pain, Postoperative, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Despite the increasing use of patient-controlled anesthesia (PCA) for postoperative pain management, efforts are continuing to find effective methods to relieve pain after abdominal surgery. Although opioid is an effective analgesic it has opioid related adverse events (ORAEs). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- Exparel, Bupivacain and Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to 31 Mar 2018
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fulfills NIH criteria for bariatric surgery
- Planned operation of laparoscopic Roux-en Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) as primary bariatric procedure
Who cannot join
- BMI <35 and > 60 kg/m2
- Inability to walk (bed-bound or wheelchair dependence)
- Previous major abdominal surgery (possible adhesions and longer operation) defined as:
- open abdominal surgeries except simple appendectomy and common OB/GYN procedures in the pelvis (hysterectomy, C-section, and oophorectomy, tubal ligation)
- laparoscopic bowel or solid organ resection except laparoscopic cholecystectomy
- ventral hernia repair with mesh
Show all 17Show fewer
- Preoperative chronic opiate use for chronic pain defined as opiate usage at least 60 mg/day of morphine equivalent for ≥ 3 months (as defined by International Association for the Study of Pain22) in the one year period prior to the bariatric surgery
- The American Society of Anesthesiologists (ASA) score > 3
- History of hypersensitivity or adverse reaction to bupivacaine or narcotics
- Inability to speak English
- Concurrent surgical procedure including:
- ventral hernia repair
- Cholecystectomy
- hiatal hernia repair with posterior cruroplasty
- extensive lysis of adhesions
- other procedures that mandate addition of "trocar(s)" or "feeding tube"
- Addition of trocar(s) or conversion of surgery to hand-assisted or open
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bupivacaine Liposomal Injection (Exparel) for Postsurgical Analgesia in Patients Undergoing Laparoscopic Bariatric Surgery: A Randomized, Double-Blind, Controlled Trial
Despite the increasing use of patient-controlled anesthesia (PCA) for postoperative pain management, efforts are continuing to find effective methods to relieve pain after abdominal surgery. Although opioid is an effective analgesic it has opioid related adverse events (ORAEs). Bupivacaine should reduce postoperative pain but it has relatively shorter duration of action. Liposome bupivacaine (Exparel) has been approved as a single dose infiltration for longer postoperative period analgesic. It provides up to 72 hours analgesia postoperatively; results in lesser opioids usage and reduce the ORAEs. Transversus abdominis plane (TAP) block is a relatively new regional anesthetic technique. TAP blocks have been performed to reduce opioid use and control pain in several laparoscopic surgical procedures, including colorectal resections, cholecystectomy and bariatric surgery. The aim of this study is to study the opiate usage, pain and nausea post laparoscopic gastric bypass or sleeve gastrectomy using Exparel versus Bupivacaine as TAP block and port sites infiltration.
Read the detailed description
Introduction
Despite the increasing use of patient-controlled anesthesia (PCA) for postoperative pain management, efforts are continuing to find effective methods to relieve pain after abdominal surgery. Some studies have already suggested that infusion with local anesthetics at the wound site can decrease postoperative pain levels. Further, other studies have shown equal amounts of opiate analgesic requirements (administered on patient demand) with placebo and local anesthetic administration. However, varying anesthetic administration techniques used in the different studies may explain why the controversy in the literature exists.
Although opioid is an effective analgesic it has opioid related adverse events (ORAEs). Bupivacaine should reduce postoperative pain but it has relatively shorter duration of action. Liposome bupivacaine (Exparel) has been approved as a single dose infiltration for longer postoperative period analgesic. It provides up to 72 hours analgesia postoperatively; results in lesser opioids usage and reduce the ORAEs.
Transversus abdominis plane (TAP) block is a relatively new regional anesthetic technique that targets blockage of the neural afferent of the lower intercostal, iliohypogastric and ilioinguinal nerves in the neurovascular plane between the internal oblique and the transversus abdominis muscle. TAP blocks have been performed to reduce opioid use and control pain in several laparoscopic surgical procedures, including colorectal resections, cholecystectomy and bariatric surgery.
Efficacy of wound infiltration with or without TAP block using immediate-release bupivacaine HCl for acute postsurgical pain is well established; EXPAREL has been proposed as a method for postoperative pain management. Moreover, the administration and the optimal dosage in the bariatric surgical population have not been studied.
The objective of this study is to examine postoperative pain after laparoscopic gastric bypass with TAP block and port sites infiltration using Exparel versus Bupivacaine
Background and significance
Exparel is a FDA approved long-acting, local anesthetic. This is for single-dose infiltration into the surgical site to produce postsurgical analgesia. Exparel offers longer-acting local formulation and can be administered as a single dose. Exparel has a longer duration of action with slower absorption. The mean elimination half-life of local administration of Exparel is approximately 24-34 hours 19-20 versus 2.7 hours for bupivacaine.
Liposomal bupivacaine is for single-dose infiltration and the recommended dose depends on the surgical site but the maximum dose of liposomal bupivacaine is 266 mg and it is injected into soft tissues of the surgical site with frequent aspirations to prevent intravascular injection.
A pooled analysis evaluating the effect of Exparel on pain intensity scores and opioid consumption was published by Dasta et al. This study included 5 surgical procedures (inguinal hernia repair, total knee replacement, hemorrhoidectomy, breast augmentation and bunionectomy) comparing Exparel with bupivacaine HCl, on 912 patients; it showed significantly lower pain score and opioid usage, delayed use of rescue opioid and reduced ORAEs in the Exparel group; as compared to bupivacaine HCL group.
Medication SafetLiposomal bupivacaine has been classified as a high-alert medication by the Institute of Safe Medication Practices due to its similar appearance to propofol. If liposomal bupivacaine were administered intravenously as if it were propofol, adverse cardiac effects may result.
Hypothesis
Exparel (1.3%) and 0.5% Bupivacaine usage with infiltration and TAP block decreases opiate usage, nausea and pain at 48 hours as compared to 0.5% Bupivacaine only.
Primary Objective of the study:
To study the opiate usage, pain and nausea post laparoscopic gastric bypass or sleeve gastrectomy using EXPAREL versus Bupivacaine as TAP block and port sites infiltration.
- Conditions
- Pain, Postoperative
- Being tested
- Exparel, Bupivacain, Saline
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExparelDrug
6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Exparel will be injected at port sites.
BupivacainDrug
6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Bupivacain will be injected at port sites.
SalineDrug
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Patients at our Bariatric Surgery Center of Excellence fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic Roux-en Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) as primary bariatric procedure randomized to receive 20 ml of 1.3% Exparel + 30 ml of 0.5% Bupivacaine + 150 ml of Saline Receives: Drug: Exparel; Drug: Bupivacain; Drug: Saline |
| Control | Active comparator | Patients at our Bariatric Surgery Center of Excellence fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic Roux-en Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) as primary bariatric procedure randomized to receive 60ml of 0.5% Bupivacaine + 140 ml of Saline. Receives: Drug: Bupivacain; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Amount of Opioids at 48 Hours
The total amount of opioids used will be recorded from the nurse chart.
Measured: At 48 hours post operative
Secondary outcomes (2)
Cumulative Pain Score Through 48 Hours After Surgery
Description: We used a time weight average (TWA) pain score in frequent measurements of pain score.
Cumulative pain score through 48 hours after surgery is the summation of all the time weight average pain scores with a range from 0 to 440.
The high score represents the worse outcomes. 0 means no pain during the whole time and 440 means severe pain during the whole time.
Measured: Pain assessed when the patient is admitted to the recovery room after surgery, every 8 hrs thereafter for up to 48 hours post operatively
Cumulative Nausea Score
Description: We used a time weight average (TWA) method in adjusting the nausea score.
Cumulative nausea score through 72 hours after surgery is the summation of all the time weight average nausea scores with a range from 68-272.
The high score represents the worse outcomes. 68 means no nausea during the whole time and 272 means severe nausea during the whole time.
Measured: Nausea assessed when the patient is admitted to the recovery room after surgery, every 8 hrs thereafter for up to 72 hours post operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study startNov 2016
- Primary completion31 Jan 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip Schauer, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969187
- Sponsor's protocol ID
- 15-1318
- Status last verified
- Feb 2020
- First submitted
- 9 Nov 2016
- Last updated
- 3 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bupivacaine Liposomal Injection (Exparel) for Postsurgical Analgesia in Patients Undergoing Laparoscopic Bariatric Surgery: A Randomized, Double-Blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT02969187
- Acronym / sponsor ID
- 15-1318
- Conditions
- Pain, Postoperative
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 21 Nov 2016 (estimated)
- Results
- Posted 3 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Despite the increasing use of patient-controlled anesthesia (PCA) for postoperative pain management, efforts are continuing to find effective methods to relieve pain after abdominal surgery. Although opioid is an effective analgesic it has opioid related adverse events (ORAEs). Bupivacaine should reduce postoperative pain but it has relatively shorter duration of action. Liposome bupivacaine (Exparel) has been approved as a single dose infiltration for longer postoperative period analgesic. It provides up to 72 hours analgesia postoperatively; results in lesser opioids usage and reduce the ORAEs. Transversus abdominis plane (TAP) block is a relatively new regional anesthetic technique. TAP blocks have been performed to reduce opioid use and control pain in several laparoscopic surgical procedures, including colorectal resections, cholecystectomy and bariatric surgery. The aim of this study is to study the opiate usage, pain and nausea post laparoscopic gastric bypass or sleeve gastrectomy using Exparel versus Bupivacaine as TAP block and port sites infiltration.
Detailed description
Introduction
Despite the increasing use of patient-controlled anesthesia (PCA) for postoperative pain management, efforts are continuing to find effective methods to relieve pain after abdominal surgery. Some studies have already suggested that infusion with local anesthetics at the wound site can decrease postoperative pain levels. Further, other studies have shown equal amounts of opiate analgesic requirements (administered on patient demand) with placebo and local anesthetic administration. However, varying anesthetic administration techniques used in the different studies may explain why the controversy in the literature exists.
Although opioid is an effective analgesic it has opioid related adverse events (ORAEs). Bupivacaine should reduce postoperative pain but it has relatively shorter duration of action. Liposome bupivacaine (Exparel) has been approved as a single dose infiltration for longer postoperative period analgesic. It provides up to 72 hours analgesia postoperatively; results in lesser opioids usage and reduce the ORAEs.
Transversus abdominis plane (TAP) block is a relatively new regional anesthetic technique that targets blockage of the neural afferent of the lower intercostal, iliohypogastric and ilioinguinal nerves in the neurovascular plane between the internal oblique and the transversus abdominis muscle. TAP blocks have been performed to reduce opioid use and control pain in several laparoscopic surgical procedures, including colorectal resections, cholecystectomy and bariatric surgery.
Efficacy of wound infiltration with or without TAP block using immediate-release bupivacaine HCl for acute postsurgical pain is well established; EXPAREL has been proposed as a method for postoperative pain management. Moreover, the administration and the optimal dosage in the bariatric surgical population have not been studied.
The objective of this study is to examine postoperative pain after laparoscopic gastric bypass with TAP block and port sites infiltration using Exparel versus Bupivacaine
Background and significance
Exparel is a FDA approved long-acting, local anesthetic. This is for single-dose infiltration into the surgical site to produce postsurgical analgesia. Exparel offers longer-acting local formulation and can be administered as a single dose. Exparel has a longer duration of action with slower absorption. The mean elimination half-life of local administration of Exparel is approximately 24-34 hours 19-20 versus 2.7 hours for bupivacaine.
Liposomal bupivacaine is for single-dose infiltration and the recommended dose depends on the surgical site but the maximum dose of liposomal bupivacaine is 266 mg and it is injected into soft tissues of the surgical site with frequent aspirations to prevent intravascular injection.
A pooled analysis evaluating the effect of Exparel on pain intensity scores and opioid consumption was published by Dasta et al. This study included 5 surgical procedures (inguinal hernia repair, total knee replacement, hemorrhoidectomy, breast augmentation and bunionectomy) comparing Exparel with bupivacaine HCl, on 912 patients; it showed significantly lower pain score and opioid usage, delayed use of rescue opioid and reduced ORAEs in the Exparel group; as compared to bupivacaine HCL group.
Medication SafetLiposomal bupivacaine has been classified as a high-alert medication by the Institute of Safe Medication Practices due to its similar appearance to propofol. If liposomal bupivacaine were administered intravenously as if it were propofol, adverse cardiac effects may result.
Hypothesis
Exparel (1.3%) and 0.5% Bupivacaine usage with infiltration and TAP block decreases opiate usage, nausea and pain at 48 hours as compared to 0.5% Bupivacaine only.
Primary Objective of the study:
To study the opiate usage, pain and nausea post laparoscopic gastric bypass or sleeve gastrectomy using EXPAREL versus Bupivacaine as TAP block and port sites infiltration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: Exparel, Drug: Bupivacain, Drug: SalinePatients at our Bariatric Surgery Center of Excellence fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic Roux-en Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) as primary bariatric procedure randomized to receive 20 ml of 1.3% Exparel + 30 ml of 0.5% Bupivacaine + 150 ml of Saline |
| Control | Active comparator | Drug: Bupivacain, Drug: SalinePatients at our Bariatric Surgery Center of Excellence fulfilling NIH criteria for bariatric surgery and planned operation of laparoscopic Roux-en Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) as primary bariatric procedure randomized to receive 60ml of 0.5% Bupivacaine + 140 ml of Saline. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Fulfills NIH criteria for bariatric surgery
- Planned operation of laparoscopic Roux-en Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG) as primary bariatric procedure
Key exclusion criteria (17 listed)
- BMI <35 and > 60 kg/m2
- Inability to walk (bed-bound or wheelchair dependence)
- Previous major abdominal surgery (possible adhesions and longer operation) defined as:
- Preoperative chronic opiate use for chronic pain defined as opiate usage at least 60 mg/day of morphine equivalent for ≥ 3 months (as defined by International Association for the Study of Pain22) in the one year period prior to the bariatric surgery
- The American Society of Anesthesiologists (ASA) score > 3
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 |
|---|---|---|
| Exparel6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Exparel will be injected at port sites. | Drug | Experimental |
| Bupivacain6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Bupivacain will be injected at port sites. | Drug | Control, Experimental |
| Saline | Drug | Control, Experimental |
Primary outcome
Total Amount of Opioids at 48 Hours
Time frame: At 48 hours post operative
The total amount of opioids used will be recorded from the nurse chart.
2 secondary outcomes
Cumulative Pain Score Through 48 Hours After Surgery
Time frame: Pain assessed when the patient is admitted to the recovery room after surgery, every 8 hrs thereafter for up to 48 hours post operatively
Cumulative Nausea Score
Time frame: Nausea assessed when the patient is admitted to the recovery room after surgery, every 8 hrs thereafter for up to 72 hours post operatively
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Exparel, Bupivacain and Saline in people with Pain, Postoperative, run by The Cleveland Clinic at 1 site in United States.
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 2 inclusion and 17 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 3 Mar 2020. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Total Amount of Opioids at 48 Hours (time frame: At 48 hours post operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2020.