Gynecologic DiseaseNCT02450084
Ultrasound-guided Bilateral Rectus Sheath Block for Robotic Single-port Gynecologic Surgery
A study testing Rectus sheath block, Ropivacaine and Bandage in people with Gynecologic Disease, run by Ewha Womans University Mokdong Hospital at 1 site in South Korea.
Trial summary
Rectus sheath block (RSB) is a kind of anterior abdominal wall block. It has postoperative analgesic effect for abdominal surgery with midline incision. Robotic gynecologic surgery is accompanied by significant postoperative pain and usually IV-PCA is used to manage the pain.The purpose of this study is to investigate… Read more about this study
- Who is it for?
- Ages 21 to 60 years, women only
- Conditions the study is for
- Gynecologic Disease
- What is being tested?
- Rectus sheath block, Ropivacaine and Bandage
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2015to 31 Jan 2017
- 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 21 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Robotic single-port gynecologic surgery
- American society of Anesthesiologists (ASA) physical status classification I-II
- Age: 21-60
Who cannot join
- Gynecologic cancer operation
- History of previous abdominal surgery
- Allergy to local anesthetics(ropivacaine)
- Opioid tolerance
- Coagulopathy
- Infection at the needle insertion site
- Difficulty to cooperating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Analgesic Effects of Ultrasound-guided Bilateral Rectus Sheath Block for Robotic Single-port Gynecologic Surgery
Rectus sheath block (RSB) is a kind of anterior abdominal wall block. It has postoperative analgesic effect for abdominal surgery with midline incision. Robotic gynecologic surgery is accompanied by significant postoperative pain and usually IV-PCA is used to manage the pain.The purpose of this study is to investigate the analgesic effect of ultrasound-guided RSB to single-port robotic gynecologic surgery which has incision site at umbilical area. Patients will randomly assigned to two groups, RSB group and Control group. Each patients will assessed for time to first rescue analgesia, verbal numerical rating pain scores, number of rescue analgesic demands, and postoperatively opioids use by IV-PCA by a blinded investigator at 0, 1, 6, 12, 24 and 48 hours postoperatively.
Read the detailed description
Patients of RSB group will be performed ultrasound-guided bilateral RSB after induction of general anesthesia. The procedure will be performed bilaterally and 15 ml on each side, total 30 ml of 0.25% ropivacaine will be injected. After the procedure, a surgery scheduled will be proceeded. Patient of Control group will be proceeded the surgery after induction of anesthesia. All patients will use total 100 ml of IV-PCA containing 800 µg of fentanyl for 48 hours postoperatively. If a patient complains pain more intense than VNRS 4 or demands an analgesic drug, a rescue analgesic would be allowed.
- Conditions
- Gynecologic Disease
- Being tested
- Rectus sheath block, Ropivacaine, Bandage, IV-PCA containing Fentanyl
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectus sheath blockProcedure or surgery
Also called RSB
Ultrasound-guided bilateral rectus sheath block of RSB group using 0.25% Ropivacaine
RopivacaineDrug
Also called Naropin
Ultrasound-guided bilateral rectus sheath block of RSB group using 0.25% Ropivacaine
BandageOther
After the surgery, a bandage will be attached on injection site where is same as the incision site of surgery.
IV-PCA containing FentanylDrug
Also called Intravenous patient controlled analgesia using fentanyl
All patients will use total 100 ml of IV-PCA containing 800 µg of fentanyl for 48 hours postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Rectus sheath block | Experimental | Patients of RSB group will be performed ultrasound-guided bilateral RSB after induction of general anesthesia. After draping the needle insertion site, a 22-gauge, 50-mm needle will be inserted medial to the probe by the in-plane technique and advanced in a lateral direction on just lateral to umbilicus. 15 ml of 0.25% ropivacaine will be injected on the posterior border of rectus muscle. This procedure will be performed bilaterally and total 30 ml of 0.25% ropivacaine will be injected. After the surgery, a bandage will be attached on injection site where is same as the incision site of surgery. All patients will use total 100 ml of IV-PCA containing fentanyl 800 µg for 48 hours postoperatively. Receives: Procedure: Rectus sheath block; Drug: Ropivacaine; Other: Bandage; Drug: IV-PCA containing Fentanyl |
| Control | Sham comparator | Patients of Control group will be proceeded a surgery scheduled after induction of general anesthesia without any procedure such as placebo injection. After the surgery, a bandage will be attached on the incision site where is same as the block injection site of RSB group. All patients will use total 100 ml of IV-PCA containing fentanyl 800µg for 48 hours postoperatively. Receives: Other: Bandage; Drug: IV-PCA containing Fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal numerical rating scale
Postoperative pain on each time point which is expressed by verbal numerical rating scale (0 ~ 10)
Measured: 6 hours postoperatively
Secondary outcomes (3)
Total opioids use
Total dosage of injected fentanyl through IV-PCA
Measured: 0, 1, 6, 12, 24, 48 hours postoperatively
Time to first rescue analgesic request
How long it takes postoperative time to first additional analgesic drug injection by patient's request
Measured: 48 hours postoperatively
Verbal numerical rating scale
Postoperative pain on each time point which is expressed by verbal numerical rating scale (0 ~ 10)
Measured: 0, 1, 12, 24, 48 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2015 (estimated)
- Study startMay 2015
- Primary completion31 Jan 2017
- Study completion31 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic DiseaseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ewha Womans University Mokdong Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Youn Jin Kim, Ewha Womans University Mokdong Hospital
- Investigators
- Youn Jin Kim, MD, PhD, Principal investigator, Ewha Womans University Mokdong Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02450084
- Sponsor's protocol ID
- EUMC 2015-01-024-002
- Status last verified
- Feb 2017
- First submitted
- 8 May 2015
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Analgesic Effects of Ultrasound-guided Bilateral Rectus Sheath Block for Robotic Single-port Gynecologic Surgery
- ClinicalTrials.gov ID
- NCT02450084
- Acronym / sponsor ID
- EUMC 2015-01-024-002
- Conditions
- Gynecologic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ewha Womans University Mokdong HospitalUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 31 Jan 2017 (actual)
- First posted
- 21 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.
Rectus sheath block (RSB) is a kind of anterior abdominal wall block. It has postoperative analgesic effect for abdominal surgery with midline incision. Robotic gynecologic surgery is accompanied by significant postoperative pain and usually IV-PCA is used to manage the pain.The purpose of this study is to investigate the analgesic effect of ultrasound-guided RSB to single-port robotic gynecologic surgery which has incision site at umbilical area. Patients will randomly assigned to two groups, RSB group and Control group. Each patients will assessed for time to first rescue analgesia, verbal numerical rating pain scores, number of rescue analgesic demands, and postoperatively opioids use by IV-PCA by a blinded investigator at 0, 1, 6, 12, 24 and 48 hours postoperatively.
Detailed description
Patients of RSB group will be performed ultrasound-guided bilateral RSB after induction of general anesthesia. The procedure will be performed bilaterally and 15 ml on each side, total 30 ml of 0.25% ropivacaine will be injected. After the procedure, a surgery scheduled will be proceeded. Patient of Control group will be proceeded the surgery after induction of anesthesia. All patients will use total 100 ml of IV-PCA containing 800 µg of fentanyl for 48 hours postoperatively. If a patient complains pain more intense than VNRS 4 or demands an analgesic drug, a rescue analgesic would be allowed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rectus sheath block | Experimental | Procedure: Rectus sheath block, Drug: Ropivacaine, Other: Bandage, Drug: IV-PCA containing FentanylPatients of RSB group will be performed ultrasound-guided bilateral RSB after induction of general anesthesia. After draping the needle insertion site, a 22-gauge, 50-mm needle will be inserted medial to the probe by the in-plane technique and advanced in a lateral direction on just lateral to umbilicus. 15 ml of 0.25% ropivacaine will be injected on the posterior border of rectus muscle. This procedure will be performed bilaterally and total 30 ml of 0.25% ropivacaine will be injected. After the surgery, a bandage will be attached on injection site where is same as the incision site of surgery. All patients will use total 100 ml of IV-PCA containing fentanyl 800 µg for 48 hours postoperatively. |
| Control | Sham comparator | Other: Bandage, Drug: IV-PCA containing FentanylPatients of Control group will be proceeded a surgery scheduled after induction of general anesthesia without any procedure such as placebo injection. After the surgery, a bandage will be attached on the incision site where is same as the block injection site of RSB group. All patients will use total 100 ml of IV-PCA containing fentanyl 800µg for 48 hours postoperatively. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Robotic single-port gynecologic surgery
- American society of Anesthesiologists (ASA) physical status classification I-II
- Age: 21-60
Key exclusion criteria (7 listed)
- Gynecologic cancer operation
- History of previous abdominal surgery
- Allergy to local anesthetics(ropivacaine)
- Opioid tolerance
- Coagulopathy
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 |
|---|---|---|
| Rectus sheath blockAlso: RSBUltrasound-guided bilateral rectus sheath block of RSB group using 0.25% Ropivacaine | Procedure or surgery | Rectus sheath block |
| RopivacaineAlso: NaropinUltrasound-guided bilateral rectus sheath block of RSB group using 0.25% Ropivacaine | Drug | Rectus sheath block |
| BandageAfter the surgery, a bandage will be attached on injection site where is same as the incision site of surgery. | Other | Control, Rectus sheath block |
| IV-PCA containing FentanylAlso: Intravenous patient controlled analgesia using fentanylAll patients will use total 100 ml of IV-PCA containing 800 µg of fentanyl for 48 hours postoperatively. | Drug | Control, Rectus sheath block |
Primary outcome
Verbal numerical rating scale
Time frame: 6 hours postoperatively
Postoperative pain on each time point which is expressed by verbal numerical rating scale (0 ~ 10)
3 secondary outcomes
Total opioids use
Time frame: 0, 1, 6, 12, 24, 48 hours postoperatively
Time to first rescue analgesic request
Time frame: 48 hours postoperatively
Verbal numerical rating scale
Time frame: 0, 1, 12, 24, 48 hours postoperatively
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 8 Feb 2017.
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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.
Youn Jin Kim, MD, PhD principal investigator
Ewha Womans University Mokdong Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rectus sheath block, Ropivacaine and Bandage in people with Gynecologic Disease, run by Ewha Womans University Mokdong Hospital at 1 site in South Korea.
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 7 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 8 Feb 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 South Korea. 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 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?
Verbal numerical rating scale (time frame: 6 hours postoperatively). 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 8 Feb 2017.