HerniaNCT02447965
Pilot Study: Rectus Sheath Blocks for Improving Abdominal Surgery Conditions
A study testing Bupivacaine and Normal Saline in people with Hernia and Pain, Postoperative, run by University of Arkansas at 1 site in United States.
Trial summary
The purpose of this study is to show that the use of preoperative rectus sheath blocks can ultimately alleviate the need for using nondepolarizing muscle relaxants during certain abdominal procedures. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hernia, Pain, Postoperative, Abdominal Wall Relaxation After Rectus Sheath Block
- What is being tested?
- Bupivacaine and Normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2016to 1 Dec 2016
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Scheduled to undergo an abdominal procedure with a periumbilical or midline incision above the umbilicus
- Age ≥ 18 years.
- American Society of Anesthesiologists physical status class 1 to 3
Who cannot join
- Known coagulopathy
- Preexisting muscular disease
- Medical conditions contraindicated to bupivacaine, succinylcholine or other medication used in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Univerisity of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
About this study
Official title: Pilot Study: Rectus Sheath Blocks for Improving Abdominal Surgery Conditions: A Prospective Randomized Double-Blind Placebo Controlled Study
The purpose of this study is to show that the use of preoperative rectus sheath blocks can ultimately alleviate the need for using nondepolarizing muscle relaxants during certain abdominal procedures.
Read the detailed description
The patients in the active group will be taken to the operating room and standard american society of anesthesiologists monitors will be applied. After induction of general anesthesia, the ultrasonographic anatomy of the umbilical region will be studied in each patient. The probe will be adjusted until optimum view of both rectus abdominis muscles, their sheaths and surrounding structures are identified. Once the umbilical region anatomy has been identified the puncture sites will be determined. The puncture sites will be aseptically prepped, the ultrasound probed will be covered with a sterile tegaderm, and sterile ultrasound gel will be used on the field. A 21-g EchoStim echogenic needle will be used. The needle will be inserted in the long axis parallel to the ultrasound probe. The needle will be advanced carefully until the needle tip is seen between the posterior aspect of the rectus muscle and its sheath. After a confirmed negative aspiration, 15 ml of 0.25% bupivacaine will be inserted in 2 ml increments, aspirating in between.
The placebo group will have the exact same procedure performed except 15 ml of normal saline will be injected in each rectus sheath instead of 0.25% bupivacaine. For all patients, when the block has been completed the surgery team will then prep the patient and proceed with the planned operation. The surgery staff and anesthesia providers taking care of the patient in the operating room will be unaware of the patient's group. At this point, all patients will be treated exactly the same. For intubation purposes, all patients will only receive succinylcholine. After intubation, elimination of the succinylcholine dose will be determined using a twitch monitor on the ulnar nerve. If at any point during the surgery, the surgery team needs more muscle relaxation then the anesthesia staff will give appropriate medications.
The first step will be to administer propofol 50mg IV, if hemodynamics allow, and to verify that the patient has 1.0-1.2 minimum alveolar concentration (MAC) of volatile anesthetic. If the patient is not at 1.0 MAC, then the volatile anesthetic should be increased. If this does not provide sufficient relaxation, then a nondepolarizing muscle relaxant will be given in 10mg increments titrated to a train of four of 2 twitches at the ulnar nerve. All patients will receive ofirmev and fentanyl in the operating room for pain control. Ofirmev 1000mg will be given pre-incision to each patient and 1.5 mcg/kg loading dose of fentanyl will be given to each patient. Fentanyl will be redosed in 50mcg increments for a 20% increase in blood pressure or heart rate above preinduction values that is sustained for 5 minutes despite an adequate depth of anesthesia, defined as 1 MAC or greater.
- Being tested
- Bupivacaine, Normal Saline
- Keywords
- Rectus Sheath Blocks, Abdominal Surgery
- Medical subject headings
- Hernia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BupivacaineDrug
Also called Marcaine
Using ultrasound guidance bupivacaine will be injected into the active group's rectus abdominis sheath.
Normal SalineDrug
Using ultrasound guidance normal saline will be injected into the placebo group's rectus abdominis sheath.
| Study group | Role | What they receive |
|---|---|---|
| Bupivacaine | Active comparator | Will have 20ml of bupivacaine injected into each rectus sheath. Receives: Drug: Bupivacaine |
| Normal Saline | Placebo comparator | Will have 20ml of normal saline injected into each rectus sheath. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total consumption of nondepolarizing muscle relaxants used during abdominal surgery.
Measured: The duration of study therapy is only for the perioperative preparation period (usually 4-5 hrs) for the subject's abdominal procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2015 (estimated)
- Study start1 Jan 2016
- Primary completion1 Dec 2016
- Study completion1 Dec 2016
Why it stopped: difficult recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HerniaStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew G Cain, M.D., Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02447965
- Sponsor's protocol ID
- 203780
- Status last verified
- Jul 2017
- First submitted
- 11 May 2015
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kimura F, Oishi M, Yakoshi C, Ogasawara C, Ishihara H, Hirota K. [Rectus sheath block and transversus abdominis plane block for a patient with Lambert-Eaton myasthenic syndrome undergoing low anterior resection]. Masui. 2013 Aug;62(8):989-91. Japanese.
PubMed 23984583Quek KH, Phua DS. Bilateral rectus sheath blocks as the single anaesthetic technique for an open infraumbilical hernia repair. Singapore Med J. 2014 Mar;55(3):e39-41. doi: 10.11622/smedj.2014042.
PubMed 24664392Bashandy GM, Elkholy AH. Reducing postoperative opioid consumption by adding an ultrasound-guided rectus sheath block to multimodal analgesia for abdominal cancer surgery with midline incision. Anesth Pain Med. 2014 Aug 10;4(3):e18263. doi: 10.5812/aapm.18263. eCollection 2014 Aug.
PubMed 25289373
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Rectus Sheath Blocks for Improving Abdominal Surgery Conditions: A Prospective Randomized Double-Blind Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT02447965
- Acronym / sponsor ID
- 203780
- Keywords
- Rectus Sheath Blocks, Abdominal Surgery
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficult recruitment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 1 Jan 2016
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 19 May 2015 (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 purpose of this study is to show that the use of preoperative rectus sheath blocks can ultimately alleviate the need for using nondepolarizing muscle relaxants during certain abdominal procedures.
Detailed description
The patients in the active group will be taken to the operating room and standard american society of anesthesiologists monitors will be applied. After induction of general anesthesia, the ultrasonographic anatomy of the umbilical region will be studied in each patient. The probe will be adjusted until optimum view of both rectus abdominis muscles, their sheaths and surrounding structures are identified. Once the umbilical region anatomy has been identified the puncture sites will be determined. The puncture sites will be aseptically prepped, the ultrasound probed will be covered with a sterile tegaderm, and sterile ultrasound gel will be used on the field. A 21-g EchoStim echogenic needle will be used. The needle will be inserted in the long axis parallel to the ultrasound probe. The needle will be advanced carefully until the needle tip is seen between the posterior aspect of the rectus muscle and its sheath. After a confirmed negative aspiration, 15 ml of 0.25% bupivacaine will be inserted in 2 ml increments, aspirating in between.
The placebo group will have the exact same procedure performed except 15 ml of normal saline will be injected in each rectus sheath instead of 0.25% bupivacaine. For all patients, when the block has been completed the surgery team will then prep the patient and proceed with the planned operation. The surgery staff and anesthesia providers taking care of the patient in the operating room will be unaware of the patient's group. At this point, all patients will be treated exactly the same. For intubation purposes, all patients will only receive succinylcholine. After intubation, elimination of the succinylcholine dose will be determined using a twitch monitor on the ulnar nerve. If at any point during the surgery, the surgery team needs more muscle relaxation then the anesthesia staff will give appropriate medications.
The first step will be to administer propofol 50mg IV, if hemodynamics allow, and to verify that the patient has 1.0-1.2 minimum alveolar concentration (MAC) of volatile anesthetic. If the patient is not at 1.0 MAC, then the volatile anesthetic should be increased. If this does not provide sufficient relaxation, then a nondepolarizing muscle relaxant will be given in 10mg increments titrated to a train of four of 2 twitches at the ulnar nerve. All patients will receive ofirmev and fentanyl in the operating room for pain control. Ofirmev 1000mg will be given pre-incision to each patient and 1.5 mcg/kg loading dose of fentanyl will be given to each patient. Fentanyl will be redosed in 50mcg increments for a 20% increase in blood pressure or heart rate above preinduction values that is sustained for 5 minutes despite an adequate depth of anesthesia, defined as 1 MAC or greater.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bupivacaine | Active comparator | Drug: BupivacaineWill have 20ml of bupivacaine injected into each rectus sheath. |
| Normal Saline | Placebo comparator | Drug: Normal SalineWill have 20ml of normal saline injected into each rectus sheath. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Scheduled to undergo an abdominal procedure with a periumbilical or midline incision above the umbilicus
- Age ≥ 18 years.
- American Society of Anesthesiologists physical status class 1 to 3
Key exclusion criteria (3 listed)
- Known coagulopathy
- Preexisting muscular disease
- Medical conditions contraindicated to bupivacaine, succinylcholine or other medication used in the study
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: MarcaineUsing ultrasound guidance bupivacaine will be injected into the active group's rectus abdominis sheath. | Drug | Bupivacaine |
| Normal SalineUsing ultrasound guidance normal saline will be injected into the placebo group's rectus abdominis sheath. | Drug | Normal Saline |
Primary outcome
Total consumption of nondepolarizing muscle relaxants used during abdominal surgery.
Time frame: The duration of study therapy is only for the perioperative preparation period (usually 4-5 hrs) for the subject's abdominal procedure
Results and safety
The study was stopped early (reason given: difficult recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Background: PubMed 23984583Kimura F, Oishi M, Yakoshi C, Ogasawara C, Ishihara H, Hirota K. [Rectus sheath block and transversus abdominis plane block for a patient with Lambert-Eaton myasthenic syndrome undergoing low anterior resection]. Masui. 2013 Aug;62(8):989-91. Japanese.
- Background: PubMed 24664392Quek KH, Phua DS. Bilateral rectus sheath blocks as the single anaesthetic technique for an open infraumbilical hernia repair. Singapore Med J. 2014 Mar;55(3):e39-41. doi: 10.11622/smedj.2014042.
- Background: PubMed 25289373Bashandy GM, Elkholy AH. Reducing postoperative opioid consumption by adding an ultrasound-guided rectus sheath block to multimodal analgesia for abdominal cancer surgery with midline incision. Anesth Pain Med. 2014 Aug 10;4(3):e18263. doi: 10.5812/aapm.18263. eCollection 2014 Aug.
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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.
Andrew G Cain, M.D. principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupivacaine and Normal Saline in people with Hernia and Pain, Postoperative, run by University of Arkansas 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 3 inclusion and 3 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: stopped early, as of the sponsor's last update on 21 Jul 2017. 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. 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 stopped early (reason given: difficult recruitment). Results are not available in the source record.
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 consumption of nondepolarizing muscle relaxants used during abdominal surgery. (time frame: The duration of study therapy is only for the perioperative preparation period (usually 4-5 hrs) for the subject's abdominal procedure). 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 NCT02447965, which also lists 3 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 21 Jul 2017.