Single Port Laparoscopic Adnexal SurgeryNCT05984212
Effect of Preoperative Rectus Sheath Block on Quality of Recovery in Single Port Laparoscopic Adnexal Surgery
A study testing Ultrasound guided rectus sheath block with dexmedetomidine and Ultrasound guided rectus sheath block with normal saline in people with Single Port Laparoscopic Adnexal Surgery, run by Yonsei University at 1 site in South Korea.
Trial summary
In this study, the investigators aimed to demonstrate if the quality of recovery in patients undergoing single-port laparoscopic adnexal surgery, with preoperative rectus sheath block and intraoperative opioid administration based on analgesia nociception index, improves compared to the patients without block. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Single Port Laparoscopic Adnexal Surgery
- What is being tested?
- Ultrasound guided rectus sheath block with dexmedetomidine and Ultrasound guided rectus sheath block with normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2023to Jul 2024
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Adult female patient aged 19 years or older undergoing elective single-port laparoscopic adnexal surgery under general anesthesia at Yonsei Cancer Center
- 1. patients with moderate to severe pain before surgery 2. patients with history of taking chronic analgesic use, 3. patients allergic or hypersensite to remifentanil or local anesthetic (ropivacaine), 4. patients with infection at the site of the block, 5. patietns who cannot communicate
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Severance hospital
Seoul
Youngwon Kim, 82-10-4240-6849, youngwon@yuhs.ac
About this study
Official title: Effect of Preoperative Rectus Sheath Block on Quality of Recovery in Single Port Laparoscopic Adnexal Surgery: A Randomized Controlled Trial
In this study, the investigators aimed to demonstrate if the quality of recovery in patients undergoing single-port laparoscopic adnexal surgery, with preoperative rectus sheath block and intraoperative opioid administration based on analgesia nociception index, improves compared to the patients without block.
- Conditions
- Single Port Laparoscopic Adnexal Surgery
- Being tested
- Ultrasound guided rectus sheath block with dexmedetomidine, Ultrasound guided rectus sheath block with normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided rectus sheath block with dexmedetomidineDrug
Intervention Group: Ultrasound guided rectus sheath block with 0.5% ropivacaine 20ml at each side (bilateral)
Ultrasound guided rectus sheath block with normal salineDrug
Control Group: Ultrasound guided rectus sheath block with 0.9% normal saline 20ml at each side (bilateral)
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine infusion group | Experimental | Not described Receives: Drug: Ultrasound guided rectus sheath block with dexmedetomidine |
| normal saline infusion group | Placebo comparator | Not described Receives: Drug: Ultrasound guided rectus sheath block with normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Recovery 40 scale score at postoperative 24 hour
Postoperative quality of recovery according to the block performance
Measured: 24 hours after the end of surgery
Secondary outcomes (8)
Intraoperative remifentanil consumption,postoperative pain score
To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction
Measured: at 0, 1, 6, 12, and 24 hours postoperative
rescue analgesics administered up to 24 hours postoperatively
To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction
Measured: intraoprative and postoperative 24hours
satisfaction with pain control
Patient self-rated overall satisfaction with pain control. Evaluated on an 11-point scale from 0 to 10, with 0 points for completely dissatisfied and 10 points for complete satisfaction. The higher the number, the more satisfactory it is.
Measured: intraoprative and postoperative 24hours
serum cortisol level (μg/dL) before and after surgery
To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction
Measured: intraoprative and postoperative 24hours
leukocyte level (10^3/μL) before and after surgery
To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction
Measured: intraoprative and postoperative 24hours
arterial pH before and after surgery
To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction
Measured: intraoprative and postoperative 24hours
blood glucose level (mg/dL) before and after surgery
To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction
Measured: intraoprative and postoperative 24hours
measurement of adequate analgesia (NRS <4) before and after surgery
To evaluate the effect of rectus sheath block on intraoperative and postoperative pain and patients' satisfaction
Measured: intraoprative and postoperative 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study startAug 2023 (estimated)
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Single Port Laparoscopic Adnexal SurgeryStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double blind randomized controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Youngwon Kim, Principal investigator, Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984212
- Sponsor's protocol ID
- 4-2023-0611
- Status last verified
- Aug 2023
- First submitted
- 16 Jul 2023
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Rectus Sheath Block on Quality of Recovery in Single Port Laparoscopic Adnexal Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05984212
- Acronym / sponsor ID
- 4-2023-0611
- Conditions
- Single Port Laparoscopic Adnexal Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Aug 2023 (estimated)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 9 Aug 2023 (actual)
- 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.
In this study, the investigators aimed to demonstrate if the quality of recovery in patients undergoing single-port laparoscopic adnexal surgery, with preoperative rectus sheath block and intraoperative opioid administration based on analgesia nociception index, improves compared to the patients without block.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double blind randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine infusion group | Experimental | Drug: Ultrasound guided rectus sheath block with dexmedetomidine |
| normal saline infusion group | Placebo comparator | Drug: Ultrasound guided rectus sheath block with normal saline |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Adult female patient aged 19 years or older undergoing elective single-port laparoscopic adnexal surgery under general anesthesia at Yonsei Cancer Center
- 1. patients with moderate to severe pain before surgery 2. patients with history of taking chronic analgesic use, 3. patients allergic or hypersensite to remifentanil or local anesthetic (ropivacaine), 4. patients with infection at the site of the block, 5. patietns who cannot communicate
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Ultrasound guided rectus sheath block with dexmedetomidineIntervention Group: Ultrasound guided rectus sheath block with 0.5% ropivacaine 20ml at each side (bilateral) | Drug | dexmedetomidine infusion group |
| Ultrasound guided rectus sheath block with normal salineControl Group: Ultrasound guided rectus sheath block with 0.9% normal saline 20ml at each side (bilateral) | Drug | normal saline infusion group |
Primary outcome
Quality of Recovery 40 scale score at postoperative 24 hour
Time frame: 24 hours after the end of surgery
Postoperative quality of recovery according to the block performance
8 secondary outcomes
Intraoperative remifentanil consumption,postoperative pain score
Time frame: at 0, 1, 6, 12, and 24 hours postoperative
rescue analgesics administered up to 24 hours postoperatively
Time frame: intraoprative and postoperative 24hours
satisfaction with pain control
Time frame: intraoprative and postoperative 24hours
serum cortisol level (μg/dL) before and after surgery
Time frame: intraoprative and postoperative 24hours
leukocyte level (10^3/μL) before and after surgery
Time frame: intraoprative and postoperative 24hours
arterial pH before and after surgery
Time frame: intraoprative and postoperative 24hours
blood glucose level (mg/dL) before and after surgery
Time frame: intraoprative and postoperative 24hours
measurement of adequate analgesia (NRS <4) before and after surgery
Time frame: intraoprative and postoperative 24hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
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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.
Youngwon Kim principal investigator
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided rectus sheath block with dexmedetomidine and Ultrasound guided rectus sheath block with normal saline in people with Single Port Laparoscopic Adnexal Surgery, run by Yonsei University 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 2 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 9 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Youngwon Kim (82-10-4240-6849, youngwon@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of Recovery 40 scale score at postoperative 24 hour (time frame: 24 hours after the end of 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 9 Aug 2023.