Abdominal SurgeryNCT00557843
Continuous Bupivacaine Infusion Following Colonic Surgery
A study testing Bupivacaine and Saline in people with Abdominal Surgery, run by The Cleveland Clinic.
Trial summary
The primary objective is to evaluate the influence of continuous local anesthetic infiltration on tissue oxygenation after surgical procedures requiring abdominal surgery as a major predictor for wound healing. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Abdominal Surgery
- What is being tested?
- Bupivacaine and Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2007to Jun 2009
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years of age.
- The patient has provided written informed consent.
- The patient is scheduled for abdominal surgery.
- The patient has an ASA of I, II, or III.
- The patient understands the explanation of the protocol.
Who cannot join
- Patients aged < 18 and > 80 years.
- History of diabetes mellitus.
- History of congestive heart failure.
- History of peripheral vascular disease.
- History of smoking.
- History of Dysautonomia.
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- History of thyroid disease.
- Susceptibility to malignant hyperthermia.
- History of morbid obesity.
- History of fever
- History of infection.
- Contraindication to the placement of an arterial line; e.g., Raynaud's disease.
- The patient declines participation.
- Any patient the investigator feels is not a candidate for this study.
- Any patient with a history of known alcohol, analgesic, or narcotic substance abuse within two years of screening.
About this study
Official title: Influence of Continuous Bupivacaine Infusion on Tissue Oxygenation Following Colonic Surgery
The primary objective is to evaluate the influence of continuous local anesthetic infiltration on tissue oxygenation after surgical procedures requiring abdominal surgery as a major predictor for wound healing.
Read the detailed description
Patients undergoing abdominal surgery will be randomized to one of two groups.
Group 1: Wound perfusion with bupivacaine, plus patient controlled analgesia (PCA)
Group 2: Wound perfusion with placebo solution (isotonic saline) plus patient controlled analgesia (PCA)
All patients will be premedicated with IV midazolam up to 5 mg. On arrival to the operating room, a fluid bolus of 10 ml/kg/h will be administered before induction of anesthesia.
Those randomized to local wound perfusion will receive the local anesthetic or placebo via the ON-Q pain management system. At the end of surgery a catheter will be positioned in the subcutaneous layer of the wound, leaving via a separate stab incision. The wound closure will then be completed.
A loading dose of local anesthetic solution, 20 ml lidocaine 1% plus 20 ml bupivacaine 0.5%, or, the same amount of placebo will be injected into the wound before the patient leaves the operating room. Thereafter bupivacaine 0.5% alone or placebo will be injected continuously into the wound at a flow rate of 2 ml/h for 24 hours.
Subcutaneous oxygen tension (PsqO2) will be evaluated intraoperatively with a polygraphic-type tissue oxygen sensor positioned within a subcutaneous, saline filled Silastic® tonometer inserted into the patients' upper arm after induction of anesthesia.
Postoperative pain relief will be maintained by patient-controlled analgesia (PCA) with morphine (2mg bolus, 6-minute lock-out) and with local anesthetic wound perfusion.
Patients will be given supplemental oxygen via a face mask at a rate of 2 L/min. Additional oxygen will be given as necessary to maintain an oxygen saturation > 95%.
An observer blinded to group assignment will perform all the postoperative evaluations.
Patient chart review will be undertaken to screen for evidence of surgical wound infection. The presence of infection will be determined by review of the attending surgeon's documentation in the patient's chart.
- Conditions
- Abdominal Surgery
- Being tested
- Bupivacaine, Saline
- Keywords
- Bupivacaine, Colon, Surgery, Oxygenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Marcain, Marcaine,Sensorcaine
Wound perfusion with bupivacaine, plus patient controlled analgesia (PCA)
SalineDrug
Wound perfusion with placebo solution (isotonic saline) plus patient controlled analgesia (PCA)
| Study group | Role | What they receive |
|---|---|---|
| bupivacaine | Active comparator | Wound perfusion with bupivacaine, plus patient controlled analgesia (PCA) Receives: Drug: Bupivacaine |
| Placebo | Placebo comparator | Wound perfusion with placebo solution (isotonic saline) plus patient controlled analgesia (PCA) Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
tissue oxygenation
averge tissue oxygenation on wound healing after abdominal surgery
Measured: 24 hours post surgery
Secondary outcomes (1)
Verbal rating scales (VRS)
0 -10 scale with 0 = no pain and 10 = worst pain
Measured: 24 hours post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionJun 2009
- Study completionJun 2009
Why it stopped: No patients enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal SurgeryStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrea Kurz, MD, Principal investigator, The Cleveland ClinicDaniel I Sessler, MD, Study chair, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00557843
- Sponsor's protocol ID
- 07-758
- Status last verified
- Apr 2017
- First submitted
- 13 Nov 2007
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Continuous Bupivacaine Infusion on Tissue Oxygenation Following Colonic Surgery
- ClinicalTrials.gov ID
- NCT00557843
- Acronym / sponsor ID
- 07-758
- Conditions
- Abdominal Surgery
- Keywords
- Bupivacaine, Colon, Surgery, Oxygenation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No patients enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Nov 2007 (actual)
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 14 Nov 2007 (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.
The primary objective is to evaluate the influence of continuous local anesthetic infiltration on tissue oxygenation after surgical procedures requiring abdominal surgery as a major predictor for wound healing.
Detailed description
Patients undergoing abdominal surgery will be randomized to one of two groups.
Group 1: Wound perfusion with bupivacaine, plus patient controlled analgesia (PCA)
Group 2: Wound perfusion with placebo solution (isotonic saline) plus patient controlled analgesia (PCA)
All patients will be premedicated with IV midazolam up to 5 mg. On arrival to the operating room, a fluid bolus of 10 ml/kg/h will be administered before induction of anesthesia.
Those randomized to local wound perfusion will receive the local anesthetic or placebo via the ON-Q pain management system. At the end of surgery a catheter will be positioned in the subcutaneous layer of the wound, leaving via a separate stab incision. The wound closure will then be completed.
A loading dose of local anesthetic solution, 20 ml lidocaine 1% plus 20 ml bupivacaine 0.5%, or, the same amount of placebo will be injected into the wound before the patient leaves the operating room. Thereafter bupivacaine 0.5% alone or placebo will be injected continuously into the wound at a flow rate of 2 ml/h for 24 hours.
Subcutaneous oxygen tension (PsqO2) will be evaluated intraoperatively with a polygraphic-type tissue oxygen sensor positioned within a subcutaneous, saline filled Silastic® tonometer inserted into the patients' upper arm after induction of anesthesia.
Postoperative pain relief will be maintained by patient-controlled analgesia (PCA) with morphine (2mg bolus, 6-minute lock-out) and with local anesthetic wound perfusion.
Patients will be given supplemental oxygen via a face mask at a rate of 2 L/min. Additional oxygen will be given as necessary to maintain an oxygen saturation > 95%.
An observer blinded to group assignment will perform all the postoperative evaluations.
Patient chart review will be undertaken to screen for evidence of surgical wound infection. The presence of infection will be determined by review of the attending surgeon's documentation in the patient's chart.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bupivacaine | Active comparator | Drug: BupivacaineWound perfusion with bupivacaine, plus patient controlled analgesia (PCA) |
| Placebo | Placebo comparator | Drug: SalineWound perfusion with placebo solution (isotonic saline) plus patient controlled analgesia (PCA) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-80 years of age.
- The patient has provided written informed consent.
- The patient is scheduled for abdominal surgery.
- The patient has an ASA of I, II, or III.
- The patient understands the explanation of the protocol.
Key exclusion criteria (15 listed)
- Patients aged < 18 and > 80 years.
- History of diabetes mellitus.
- History of congestive heart failure.
- History of peripheral vascular disease.
- History of smoking.
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 |
|---|---|---|
| BupivacaineAlso: Marcain, Marcaine,SensorcaineWound perfusion with bupivacaine, plus patient controlled analgesia (PCA) | Drug | bupivacaine |
| SalineWound perfusion with placebo solution (isotonic saline) plus patient controlled analgesia (PCA) | Drug | Placebo |
Primary outcome
tissue oxygenation
Time frame: 24 hours post surgery
averge tissue oxygenation on wound healing after abdominal surgery
1 secondary outcome
Verbal rating scales (VRS)
Time frame: 24 hours post surgery
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2018.
- 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.
Andrea Kurz, MD principal investigator
The Cleveland Clinic
Daniel I Sessler, MD study chair
The Cleveland Clinic
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine and Saline in people with Abdominal Surgery, run by The Cleveland Clinic.
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 5 inclusion and 15 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: withdrawn, as of the sponsor's last update on 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
tissue oxygenation (time frame: 24 hours post surgery). 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 21 May 2018.