Elective Laparoscopic CholecystectomyPhase 1/2NCT02031510
Dexmedetomidine in Transversus Abdominis Plane Block for Laparoscopic Cholecystectomy
A Phase 1/2 study testing bupivacaine and bupivacaine-dexmedetomidine in people with Elective Laparoscopic Cholecystectomy, run by Imam Abdulrahman Bin Faisal University at 2 sites in Saudi Arabia.
Trial summary
The use of dexmedetomidine as an adjunct to bupivacaine in transversus abdominis plane block will reduce the cumulative morphine consumption after laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Elective Laparoscopic Cholecystectomy
- What is being tested?
- bupivacaine and bupivacaine-dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 195 participants
- Where
- 2 sitesSaudi Arabia
- Study dates
- Jan 2014to Mar 2015
- Phase
- Phase 1/2
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists class I and II patients
- general anaesthesia
Who cannot join
- cardiovascular disease
- respiratory disease
- neurological disease
- renal disease
- hepatic disease
- hormonal disease
Show all 18Show fewer
- pregnancy
- body mass index > 35 kg/m2)
- smokers
- alcohol abuse
- use of antipsychotics
- communication barriers
- local anesthetics allergy
- chronic use of opioids
- use of nonsteroidal anti-inflammatory drug use during the 24 hours immediately preceding surgery
- coagulation disorders
- infection at the needle insertion
- conversion of laparoscopic to open cholecystectomy
Trial locations and contacts
2 sites in 1 country.
Saudi Arabia2 sites
King Fahd Hospital of Dammam University
Khobar, Eastern Province, 31592
Dammam University
Khobar, Eastern Province, 31952
About this study
Official title: Dexmedetomidine as an Adjuvant to Bupivacaine in Transversus Abdominis Plane Block for Laparoscopic Cholecystectomy: Multicentre Study
The use of dexmedetomidine as an adjunct to bupivacaine in transversus abdominis plane block will reduce the cumulative morphine consumption after laparoscopic cholecystectomy.
Read the detailed description
Laparoscopic cholecystectomy, which is a common surgical procedure, is associated with less postoperative pain in comparison to open cholecystectomy. However, this pain needs to be treated adequately to allow early mobilization.
Ultrasound guided transversus abdominis plane (TAP) block is an established technique to manage post laparoscopic cholecystectomy pain. 1 In addition, the use of TAP blocks reduced the need for intraoperative and postoperative opioids and the side-effects associated with their use.
The aim of a TAP block is to deposit local anaesthetic in the plane between the internal oblique and transversus abdominis muscles targeting the spinal nerves in this plane. The innervation to abdominal skin, muscles and parietal peritoneum will be interrupted.
Dexmedetomidine which is an Alpha 2-adrenergic agonist produces analgesia via a non-opioid mechanism and is also known to enhance central and peripheral neural blockades.2 Dexmedetomidine added to bupivacaine or levobupivacaine for brachial plexus block shortens sensory and motor block onset time, extends motor and sensory block durations, and also extends the postoperative analgesia.3, 4
We postulate that the use of dexmedetomidine as an adjunct to bupivacaine in transversus abdominis plane block will reduce the morphine consumption after laparoscopic cholecystectomy.
Based upon previous published data,4 a priori power analysis indicated that 60 patients in each group would be sufficient to detect a 30% reduction in the 24-hours cumulative morphine consumption, which is considered to be of clinical validity, with a type-I error of 0.0167 (0.05/4) and a power of 80%. We added 10% extra patients to compensate for possible dropouts.
All patients will be familiarized with a 10-cm visual analogue scale (VAS) (0= no pain; 10= worst imaginable) to assess the intensity of pain and on the use of the patient-controlled analgesia (PCA).
Monitoring includes non-invasive blood pressure, and electrocardiography, pulse oximetry.
An intravenous infusion of 10 ml kg-1 of Lactated Ringer's solution will be initiated before surgery and will be followed by 5 ml kg-1 hr-1 throughout the procedure.
Anaesthesia technique will be standardized. Anesthesia will be induced by fentanyl of 2-3 µg kg-1, propofol 1.5-2.5 mg kg-1, and rocuronium 0.6 mg kg-1. Tracheal intubation will be carried out at the development of maximum block as monitored by the train-of-four (TOF).
Anesthesia, consisting of a 0.7-1.5 minimum alveolar concentration (MAC) of sevoflurane, will be administered to maintain heart rate (HR) and mean arterial blood pressure (MAP) values below 20% of baseline values. Fentanyl 0.5μg/kg increments will be administered when the HR and MAP values are > 20% of baseline values, despite a target sevoflurane of MAC ≥ 1.5. When the HR and MAP values < 20% of baseline values, the sevoflurane MAC is decreased gradually to 0.7 MAC.
Patients' lungs will be ventilated to achieve a PaCO2 of 35-45 mm Hg. All patients will receive intravenous granisetron 1 mg and lornoxicam 16 mg after the induction of anaesthesia. Rocuronium increments will be given to maintain suppression of the second twitch in the TOF.
The anaesthesiologists who will perform the TAP block and give the anaesthetics will not be involved in the patients' assessment. All other staff in the operating room is unaware of the randomization code.
The TAP block will be performed using ultrasound (SonoSite M-Turbo®, Sonosite, USA) guidance as described by Ra et al
All operations will be performed by the same surgeons. CO2 pneumoperitoneum will be introduced and intra-abdominal insufflation pressure will be limited to 12 mm Hg. After introducing of the four trocars, the patient will be placed in the reverse Trendelenburg position, using up to 30° of head-up tilt. No supplementary dose of muscle relaxant was administered 30 minutes before the end of the surgery.
After desufflation of CO2 pneumoperitoneum, the patient will be returned to the horizontal position and during skin closure; neuromuscular blockade will be antagonized with 50 µg kg-1 neostigmine and 10 µg kg-1 glycopyrrolate. At the last skin suture, desflurane will be discontinued and tracheal extubation will be performed at the discretion of the involved anesthetist in the patient's management.
A standard postoperative analgesic regimen, consisting of 12-hourly intravenous lornoxicam 8 mg, 6-hourly intravenous paracetamol 1 g and intravenous morphine PCA (incremental dose, 1 mg; lockout time, 6-min; a maximum 4-hourly limit, 30 mg), will be used in all patients. If the patient has persistent postoperative nausea and/or vomiting, metoclopramide 10 mg will be administered intravenously when needed.
Other independent investigators who will be blinded to the study protocol and the patient's randomization code will collect the patient's data.
- Conditions
- Elective Laparoscopic Cholecystectomy
- Being tested
- placebo, bupivacaine, bupivacaine-dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
transversus abdominis plane block with saline 0.9%
bupivacaineDrug
transversus abdominis plane block bupivacaine 0.25%
bupivacaine-dexmedetomidineDrug
transversus abdominis plane block with bupivacaine 0.25% with dexmedetomidine 1 µg Kg-1
| Study group | Role | What they receive |
|---|---|---|
| bupivacaine-dexmedetomidine | Active comparator | transversus abdominis plane block with bupivacaine 0.25% with dexmedetomidine 1 µg Kg-1 Receives: Drug: bupivacaine-dexmedetomidine |
| bupivacaine | Active comparator | transversus abdominis plane block with bupivacaine 0.25% Receives: Drug: bupivacaine |
| placebo | Placebo comparator | Transversus abdominis block with saline 0.9% Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative 24-hours cumulative morphine consumption
the retrieved postoperative 24-hours cumulative morphine consumption from the PCA pump report
Measured: for 24 hours after surgery
Secondary outcomes (5)
cumulative use of fentanyl
the cumulative doses of fentanyl (from induction through the end of the surgery)
Measured: for 2 hours during surgery
postoperative pain at rest
the degree of postoperative pain at rest at 0.5, 2, 4, 6, 8, 12, 16, 20 and 24 h postoperatively
Measured: for 24 hours after surgery
postoperative pain on movement
the degree of postoperative pain at rest at 0.5, 2, 4, 6, 8, 12, 16, 20 and 24 h postoperatively
Measured: for 24 hours aftersurgery
sedation scores
the degree of sedation scores at 0.5, 2, 4, 6, 8, 12, 16, 20 and 24 h postoperatively
Measured: For 24 hours after surgery
Time to bowel recovery
the times to first flatus, defecation, intake of clear liquid, and solid food tolerated
Measured: for 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionFeb 2015
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Laparoscopic CholecystectomyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imam Abdulrahman Bin Faisal University
- Sponsor type
- University, hospital or other
- Collaborators
- Mansoura University
- Responsible party
- Sponsor
- Investigators
- Abdulmohsen A Al Ghamdi, MD, Principal investigator, Chairman of Anesthesiology Dept
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031510
- Sponsor's protocol ID
- Anesth-Nov13(2)
- Status last verified
- Apr 2015
- First submitted
- 7 Jan 2014
- Last updated
- 6 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dexmedetomidine as an Adjuvant to Bupivacaine in Transversus Abdominis Plane Block for Laparoscopic Cholecystectomy: Multicentre Study
- ClinicalTrials.gov ID
- NCT02031510
- Acronym / sponsor ID
- Anesth-Nov13(2)
- Conditions
- Elective Laparoscopic Cholecystectomy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Imam Abdulrahman Bin Faisal UniversityUniversity, hospital or other
- Collaborators
- Mansoura University
- Study start
- Jan 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 9 Jan 2014 (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 use of dexmedetomidine as an adjunct to bupivacaine in transversus abdominis plane block will reduce the cumulative morphine consumption after laparoscopic cholecystectomy.
Detailed description
Laparoscopic cholecystectomy, which is a common surgical procedure, is associated with less postoperative pain in comparison to open cholecystectomy. However, this pain needs to be treated adequately to allow early mobilization.
Ultrasound guided transversus abdominis plane (TAP) block is an established technique to manage post laparoscopic cholecystectomy pain. 1 In addition, the use of TAP blocks reduced the need for intraoperative and postoperative opioids and the side-effects associated with their use.
The aim of a TAP block is to deposit local anaesthetic in the plane between the internal oblique and transversus abdominis muscles targeting the spinal nerves in this plane. The innervation to abdominal skin, muscles and parietal peritoneum will be interrupted.
Dexmedetomidine which is an Alpha 2-adrenergic agonist produces analgesia via a non-opioid mechanism and is also known to enhance central and peripheral neural blockades.2 Dexmedetomidine added to bupivacaine or levobupivacaine for brachial plexus block shortens sensory and motor block onset time, extends motor and sensory block durations, and also extends the postoperative analgesia.3, 4
We postulate that the use of dexmedetomidine as an adjunct to bupivacaine in transversus abdominis plane block will reduce the morphine consumption after laparoscopic cholecystectomy.
Based upon previous published data,4 a priori power analysis indicated that 60 patients in each group would be sufficient to detect a 30% reduction in the 24-hours cumulative morphine consumption, which is considered to be of clinical validity, with a type-I error of 0.0167 (0.05/4) and a power of 80%. We added 10% extra patients to compensate for possible dropouts.
All patients will be familiarized with a 10-cm visual analogue scale (VAS) (0= no pain; 10= worst imaginable) to assess the intensity of pain and on the use of the patient-controlled analgesia (PCA).
Monitoring includes non-invasive blood pressure, and electrocardiography, pulse oximetry.
An intravenous infusion of 10 ml kg-1 of Lactated Ringer's solution will be initiated before surgery and will be followed by 5 ml kg-1 hr-1 throughout the procedure.
Anaesthesia technique will be standardized. Anesthesia will be induced by fentanyl of 2-3 µg kg-1, propofol 1.5-2.5 mg kg-1, and rocuronium 0.6 mg kg-1. Tracheal intubation will be carried out at the development of maximum block as monitored by the train-of-four (TOF).
Anesthesia, consisting of a 0.7-1.5 minimum alveolar concentration (MAC) of sevoflurane, will be administered to maintain heart rate (HR) and mean arterial blood pressure (MAP) values below 20% of baseline values. Fentanyl 0.5μg/kg increments will be administered when the HR and MAP values are > 20% of baseline values, despite a target sevoflurane of MAC ≥ 1.5. When the HR and MAP values < 20% of baseline values, the sevoflurane MAC is decreased gradually to 0.7 MAC.
Patients' lungs will be ventilated to achieve a PaCO2 of 35-45 mm Hg. All patients will receive intravenous granisetron 1 mg and lornoxicam 16 mg after the induction of anaesthesia. Rocuronium increments will be given to maintain suppression of the second twitch in the TOF.
The anaesthesiologists who will perform the TAP block and give the anaesthetics will not be involved in the patients' assessment. All other staff in the operating room is unaware of the randomization code.
The TAP block will be performed using ultrasound (SonoSite M-Turbo®, Sonosite, USA) guidance as described by Ra et al
All operations will be performed by the same surgeons. CO2 pneumoperitoneum will be introduced and intra-abdominal insufflation pressure will be limited to 12 mm Hg. After introducing of the four trocars, the patient will be placed in the reverse Trendelenburg position, using up to 30° of head-up tilt. No supplementary dose of muscle relaxant was administered 30 minutes before the end of the surgery.
After desufflation of CO2 pneumoperitoneum, the patient will be returned to the horizontal position and during skin closure; neuromuscular blockade will be antagonized with 50 µg kg-1 neostigmine and 10 µg kg-1 glycopyrrolate. At the last skin suture, desflurane will be discontinued and tracheal extubation will be performed at the discretion of the involved anesthetist in the patient's management.
A standard postoperative analgesic regimen, consisting of 12-hourly intravenous lornoxicam 8 mg, 6-hourly intravenous paracetamol 1 g and intravenous morphine PCA (incremental dose, 1 mg; lockout time, 6-min; a maximum 4-hourly limit, 30 mg), will be used in all patients. If the patient has persistent postoperative nausea and/or vomiting, metoclopramide 10 mg will be administered intravenously when needed.
Other independent investigators who will be blinded to the study protocol and the patient's randomization code will collect the patient's data.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| bupivacaine-dexmedetomidine | Active comparator | Drug: bupivacaine-dexmedetomidinetransversus abdominis plane block with bupivacaine 0.25% with dexmedetomidine 1 µg Kg-1 |
| bupivacaine | Active comparator | Drug: bupivacainetransversus abdominis plane block with bupivacaine 0.25% |
| placebo | Placebo comparator | Drug: placeboTransversus abdominis block with saline 0.9% |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologists class I and II patients
- general anaesthesia
Key exclusion criteria (18 listed)
- cardiovascular disease
- respiratory disease
- neurological disease
- renal disease
- hepatic disease
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 |
|---|---|---|
| placebotransversus abdominis plane block with saline 0.9% | Drug | placebo |
| bupivacainetransversus abdominis plane block bupivacaine 0.25% | Drug | bupivacaine |
| bupivacaine-dexmedetomidinetransversus abdominis plane block with bupivacaine 0.25% with dexmedetomidine 1 µg Kg-1 | Drug | bupivacaine-dexmedetomidine |
Primary outcome
postoperative 24-hours cumulative morphine consumption
Time frame: for 24 hours after surgery
the retrieved postoperative 24-hours cumulative morphine consumption from the PCA pump report
5 secondary outcomes
cumulative use of fentanyl
Time frame: for 2 hours during surgery
postoperative pain at rest
Time frame: for 24 hours after surgery
postoperative pain on movement
Time frame: for 24 hours aftersurgery
sedation scores
Time frame: For 24 hours after surgery
Time to bowel recovery
Time frame: for 24 hours after surgery
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 6 Apr 2015.
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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.
Abdulmohsen A Al Ghamdi, MD principal investigator
Chairman of Anesthesiology Dept
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing bupivacaine and bupivacaine-dexmedetomidine in people with Elective Laparoscopic Cholecystectomy, run by Imam Abdulrahman Bin Faisal University at 2 sites in Saudi Arabia.
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 18 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 6 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Saudi Arabia. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 24-hours cumulative morphine consumption (time frame: for 24 hours after 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 6 Apr 2015.