Gynecological LaparoscopyRSBNCT06862947
Ultrasound-Guided Rectus Sheath Block in Gynecological Single-Port Laparoscopy
A study testing Rectus Sheath Block in people with Gynecological Laparoscopy and Postoperative Pain, run by Chengdu Jinjiang Maternity and Child Health Hospital at 1 site in China.
Trial summary
Title: Ultrasound-Guided Rectus Sheath Block in Gynecological Single-Port Laparoscopy Brief Summary: This study aims to evaluate the effects of preoperative ultrasound-guided bilateral rectus sheath block (RSB) on analgesic efficacy and recovery outcomes in patients undergoing gynecological single-port laparoscopy. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Gynecological Laparoscopy, Postoperative Pain, Rectus Sheath Block
- What is being tested?
- Rectus Sheath Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 26 Apr 2022to 1 Oct 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 65 years
- Physical status classified as I or II according to the American Society of Anesthesiologists (ASA)
- Surgical durations of less than 2 hours
Who cannot join
- Infection at the planned puncture site
- Neurological disorders or nerve injuries
- Conversion to open surgery for various reasons during the procedure
- Coagulation abnormalities
- Patients had the option to withdraw from the study at any time if they chose not to continue their participation.
Trial locations and contacts
1 site in 1 country.
China1 site
Chengdu Jinjiang District Women & Children Health Hospital
Chengdu, Sichuan
About this study
Official title: Effects of Preoperative Bilateral Rectus Sheath Block Guided by Ultrasound on Analgesic Efficacy and Recovery in Gynecological Single-Port Laparoscopy: A Prospective Randomized Double-Blind Placebo-Controlled Study
Title: Ultrasound-Guided Rectus Sheath Block in Gynecological Single-Port Laparoscopy
Brief Summary:
This study aims to evaluate the effects of preoperative ultrasound-guided bilateral rectus sheath block (RSB) on analgesic efficacy and recovery outcomes in patients undergoing gynecological single-port laparoscopy. The study is a prospective, randomized, double-blind, placebo-controlled trial involving 90 patients aged 18 to 65 years, with ASA I or II physical status, scheduled for single-port laparoscopic surgery lasting less than 2 hours. Participants are randomly assigned to either the RSB group or the placebo group, with 45 patients in each group. The RSB group receives bilateral RSB with 15 ml of 0.4% ropivacaine on each side, while the placebo group receives an equal volume of 0.9% saline. The primary outcome is postoperative pain assessed using the Visual Analog Scale (VAS) at multiple time points. Secondary outcomes include opioid consumption, effective activations of the analgesia pump, and postoperative recovery parameters such as time to mobilization and length of hospital stay. The study hypothesizes that preoperative ultrasound-guided bilateral RSB will significantly improve postoperative
Read the detailed description
Background:
Gynecological single-port laparoscopy has become a preferred surgical approach due to its minimal trauma, concealed scarring, and rapid postoperative recovery. However, postoperative pain and slow recovery of gastrointestinal function remain challenges. Traditional analgesic protocols often rely on opioids, which can cause adverse effects such as nausea, vomiting, bowel paralysis, and respiratory depression.
Objective:
This study aims to evaluate the effects of preoperative ultrasound-guided bilateral rectus sheath block (RSB) on analgesic efficacy and recovery outcomes in patients undergoing gynecological single-port laparoscopy.
Methods:
This is a prospective, randomized, double-blind, placebo-controlled trial. Participants are 90 patients aged 18 to 65 years, ASA I or II, scheduled for single-port laparoscopic surgery lasting less than 2 hours. They are randomly assigned to either the RSB group or the placebo group, with 45 patients in each group. The RSB group receives bilateral RSB with 15 ml of 0.4% ropivacaine on each side, while the placebo group receives an equal volume of 0.9% saline.
Interventions:
RSB Group: Bilateral RSB with 15 ml of 0.4% ropivacaine on each side. Placebo Group: Bilateral injection of 15 ml of 0.9% saline.
Outcome Measures:
Primary Outcome: Postoperative pain assessed using the Visual Analog Scale (VAS) at 30 minutes, 6 hours, 12 hours, and 24 hours postoperatively.
Secondary Outcomes: Opioid consumption, effective activations of the analgesia pump, time to mobilization, time to first passage of flatus, and length of hospital stay.
Hypothesis:
Preoperative ultrasound-guided bilateral RSB will significantly improve postoperative analgesia, reduce opioid consumption, and accelerate postoperative recovery.
Ethics Approval:
The study received approval from the Ethics Committee of Chengdu Jinjiang District Women \& Children Health Hospital (approval number: 202214).
Funding:
This study was supported by the Chengdu Medical Research Project (No. 2023465) and the Chengdu Medical Research Project (No. 2022548).
- Being tested
- Rectus Sheath Block, Placebo
- Keywords
- Gynecology, Single-Port Laparoscopy, Rectus Sheath Block, Postop Pain Management
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectus Sheath BlockProcedure or surgery
Bilateral rectus sheath block performed under ultrasound guidance using 15 ml of 0.4% ropivacaine on each side
PlaceboProcedure or surgery
Injection of 15 ml of 0.9% saline as a placebo under the same conditions as the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-Guided Rectus Sheath Block | Active comparator | Participants receive bilateral rectus sheath block with 15 ml of 0.4% ropivacaine on each side under ultrasound guidance Receives: Procedure: Rectus Sheath Block |
| Placebo | Placebo comparator | articipants receive an equal volume of 0.9% saline as a placebo Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Control
ssessment of postoperative pain using the Visual Analog Scale (VAS) scores at multiple time points (30 minutes, 6 hours, 12 hours, 24 hours, and 48 hours after surgery).
Measured: 48 hours post-surgery
Secondary outcomes (6)
Intraoperative Opioid Consumption
Total opioid consumption (sufentanil and remifentanil) during the intraoperative period.
Measured: Intraoperative
Postoperative Recovery Parameters
Time to mobilization,
Measured: 24 hours post-surgery
Postoperative Recovery Parameters
Time to first passage of flatus
Measured: 48 hours post-surgery
Postoperative Recovery Parameters
Length of hospital stay
Measured: From postoperative to discharge
Adverse Event Rates
Incidence of postoperative nausea and vomiting (PONV)
Measured: 48 hours post-surgery
Adverse Event Rates
Incidence of dizziness
Measured: 48 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 posted6 Mar 2025
- Study start26 Apr 2022
- Primary completion22 Apr 2023
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Gynecological LaparoscopyStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chengdu Jinjiang Maternity and Child Health Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fei Jia, Chengdu Jinjiang Maternity and Child Health Hospital
- Investigators
- Fei Jia, BS, Study chair, Chengdu Jinjiang District Women & Children Health Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06862947
- Sponsor's protocol ID
- 202214
- Acronym
- RSB
- Status last verified
- Mar 2025
- First submitted
- 27 Feb 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For our study "Effects of Preoperative Bilateral Rectus Sheath Block Guided by Ultrasound on Analgesic Efficacy and Recovery in Gynecological Single-Port Laparoscopy," we have decided not to share Individual Participant Data (IPD). This decision is due to privacy concerns, data security requirements, ethical approval limitations, legal restrictions, and the study's design which did not accommodate data sharing. We believe this aligns with ethical standards and operational capabilities.
Publications
Zhang Y, Zhu Y. Comparison of conventional versus single port laparoscopy for surgical treatment of gynecological diseases: a pilot study. Wideochir Inne Tech Maloinwazyjne. 2022 Mar;17(1):252-260. doi: 10.5114/wiitm.2021.105823. Epub 2021 May 5.
PubMed 35251414Wang J, Xu X, Xu J. Application of single-port procedure and ERAS management in the laparoscopic myomectomy. BMC Womens Health. 2023 Aug 1;23(1):401. doi: 10.1186/s12905-023-02550-6.
PubMed 37528370Xu M, Feng Y, Song X, Fu S, Lu X, Lai J, Lu Y, Wang X, Lai R. Combined Ultrasound-Guided Thoracic Paravertebral Nerve Block with Subcostal Transversus Abdominis Plane Block for Analgesia After Total Minimally Invasive Mckeown Esophagectomy: A Randomized, Controlled, and Prospective Study. Pain Ther. 2023 Apr;12(2):475-489. doi: 10.1007/s40122-023-00474-5. Epub 2023 Jan 17.
PubMed 36648745Liang M, Xv X, Ren C, Yao Y, Gao X. Effect of ultrasound-guided transversus abdominis plane block with rectus sheath block on patients undergoing laparoscopy-assisted radical resection of rectal cancer: a randomized, double-blind, placebo-controlled trial. BMC Anesthesiol. 2021 Mar 24;21(1):89. doi: 10.1186/s12871-021-01295-9.
PubMed 33761901Chung W, Yoon Y, Kim JW, Kwon SI, Yang JB, Lee KH, Yoo HJ. Comparing two different techniques of rectus sheath block after single port laparoscopic surgery in benign adnexal mass patients: Surgical versus ultrasonography guidance-A randomized, single-blind, case-controlled study. Eur J Obstet Gynecol Reprod Biol. 2017 Oct;217:29-33. doi: 10.1016/j.ejogrb.2017.08.020. Epub 2017 Aug 18.
PubMed 28843866Mugita M, Kawahara R, Tamai Y, Yamasaki K, Okuno S, Hanada R, Inaoka M, Funato T. Effectiveness of ultrasound-guided transversus abdominis plane block and rectus sheath block in pain control and recovery after gynecological transumbilical single-incision laparoscopic surgery. Clin Exp Obstet Gynecol. 2014;41(6):627-32.
PubMed 25551952
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Preoperative Bilateral Rectus Sheath Block Guided by Ultrasound on Analgesic Efficacy and Recovery in Gynecological Single-Port Laparoscopy: A Prospective Randomized Double-Blind Placebo-Controlled Study
- ClinicalTrials.gov ID
- NCT06862947
- Acronym / sponsor ID
- RSB / 202214
- Keywords
- Gynecology, Single-Port Laparoscopy, Rectus Sheath Block, Postop Pain Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Chengdu Jinjiang Maternity and Child Health HospitalUniversity, hospital or other
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 22 Apr 2023 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 6 Mar 2025 (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.
Title: Ultrasound-Guided Rectus Sheath Block in Gynecological Single-Port Laparoscopy
Brief Summary:
This study aims to evaluate the effects of preoperative ultrasound-guided bilateral rectus sheath block (RSB) on analgesic efficacy and recovery outcomes in patients undergoing gynecological single-port laparoscopy. The study is a prospective, randomized, double-blind, placebo-controlled trial involving 90 patients aged 18 to 65 years, with ASA I or II physical status, scheduled for single-port laparoscopic surgery lasting less than 2 hours. Participants are randomly assigned to either the RSB group or the placebo group, with 45 patients in each group. The RSB group receives bilateral RSB with 15 ml of 0.4% ropivacaine on each side, while the placebo group receives an equal volume of 0.9% saline. The primary outcome is postoperative pain assessed using the Visual Analog Scale (VAS) at multiple time points. Secondary outcomes include opioid consumption, effective activations of the analgesia pump, and postoperative recovery parameters such as time to mobilization and length of hospital stay. The study hypothesizes that preoperative ultrasound-guided bilateral RSB will significantly improve postoperative
Detailed description
Background:
Gynecological single-port laparoscopy has become a preferred surgical approach due to its minimal trauma, concealed scarring, and rapid postoperative recovery. However, postoperative pain and slow recovery of gastrointestinal function remain challenges. Traditional analgesic protocols often rely on opioids, which can cause adverse effects such as nausea, vomiting, bowel paralysis, and respiratory depression.
Objective:
This study aims to evaluate the effects of preoperative ultrasound-guided bilateral rectus sheath block (RSB) on analgesic efficacy and recovery outcomes in patients undergoing gynecological single-port laparoscopy.
Methods:
This is a prospective, randomized, double-blind, placebo-controlled trial. Participants are 90 patients aged 18 to 65 years, ASA I or II, scheduled for single-port laparoscopic surgery lasting less than 2 hours. They are randomly assigned to either the RSB group or the placebo group, with 45 patients in each group. The RSB group receives bilateral RSB with 15 ml of 0.4% ropivacaine on each side, while the placebo group receives an equal volume of 0.9% saline.
Interventions:
RSB Group: Bilateral RSB with 15 ml of 0.4% ropivacaine on each side. Placebo Group: Bilateral injection of 15 ml of 0.9% saline.
Outcome Measures:
Primary Outcome: Postoperative pain assessed using the Visual Analog Scale (VAS) at 30 minutes, 6 hours, 12 hours, and 24 hours postoperatively.
Secondary Outcomes: Opioid consumption, effective activations of the analgesia pump, time to mobilization, time to first passage of flatus, and length of hospital stay.
Hypothesis:
Preoperative ultrasound-guided bilateral RSB will significantly improve postoperative analgesia, reduce opioid consumption, and accelerate postoperative recovery.
Ethics Approval:
The study received approval from the Ethics Committee of Chengdu Jinjiang District Women \& Children Health Hospital (approval number: 202214).
Funding:
This study was supported by the Chengdu Medical Research Project (No. 2023465) and the Chengdu Medical Research Project (No. 2022548).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-Guided Rectus Sheath Block | Active comparator | Procedure: Rectus Sheath BlockParticipants receive bilateral rectus sheath block with 15 ml of 0.4% ropivacaine on each side under ultrasound guidance |
| Placebo | Placebo comparator | Procedure: Placeboarticipants receive an equal volume of 0.9% saline as a placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18 to 65 years
- Physical status classified as I or II according to the American Society of Anesthesiologists (ASA)
- Surgical durations of less than 2 hours
Key exclusion criteria (5 listed)
- Infection at the planned puncture site
- Neurological disorders or nerve injuries
- Conversion to open surgery for various reasons during the procedure
- Coagulation abnormalities
- Patients had the option to withdraw from the study at any time if they chose not to continue their participation.
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 BlockBilateral rectus sheath block performed under ultrasound guidance using 15 ml of 0.4% ropivacaine on each side | Procedure or surgery | Ultrasound-Guided Rectus Sheath Block |
| PlaceboInjection of 15 ml of 0.9% saline as a placebo under the same conditions as the experimental group. | Procedure or surgery | Placebo |
Primary outcome
Postoperative Pain Control
Time frame: 48 hours post-surgery
ssessment of postoperative pain using the Visual Analog Scale (VAS) scores at multiple time points (30 minutes, 6 hours, 12 hours, 24 hours, and 48 hours after surgery).
6 secondary outcomes
Intraoperative Opioid Consumption
Time frame: Intraoperative
Postoperative Recovery Parameters
Time frame: 24 hours post-surgery
Postoperative Recovery Parameters
Time frame: 48 hours post-surgery
Postoperative Recovery Parameters
Time frame: From postoperative to discharge
Adverse Event Rates
Time frame: 48 hours post-surgery
Adverse Event Rates
Time frame: 48 hours post-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 Mar 2025.
- Background: PubMed 35251414Zhang Y, Zhu Y. Comparison of conventional versus single port laparoscopy for surgical treatment of gynecological diseases: a pilot study. Wideochir Inne Tech Maloinwazyjne. 2022 Mar;17(1):252-260. doi: 10.5114/wiitm.2021.105823. Epub 2021 May 5.
- Background: PubMed 37528370Wang J, Xu X, Xu J. Application of single-port procedure and ERAS management in the laparoscopic myomectomy. BMC Womens Health. 2023 Aug 1;23(1):401. doi: 10.1186/s12905-023-02550-6.
- Background: PubMed 36648745Xu M, Feng Y, Song X, Fu S, Lu X, Lai J, Lu Y, Wang X, Lai R. Combined Ultrasound-Guided Thoracic Paravertebral Nerve Block with Subcostal Transversus Abdominis Plane Block for Analgesia After Total Minimally Invasive Mckeown Esophagectomy: A Randomized, Controlled, and Prospective Study. Pain Ther. 2023 Apr;12(2):475-489. doi: 10.1007/s40122-023-00474-5. Epub 2023 Jan 17.
- Background: PubMed 33761901Liang M, Xv X, Ren C, Yao Y, Gao X. Effect of ultrasound-guided transversus abdominis plane block with rectus sheath block on patients undergoing laparoscopy-assisted radical resection of rectal cancer: a randomized, double-blind, placebo-controlled trial. BMC Anesthesiol. 2021 Mar 24;21(1):89. doi: 10.1186/s12871-021-01295-9.
- Background: PubMed 28843866Chung W, Yoon Y, Kim JW, Kwon SI, Yang JB, Lee KH, Yoo HJ. Comparing two different techniques of rectus sheath block after single port laparoscopic surgery in benign adnexal mass patients: Surgical versus ultrasonography guidance-A randomized, single-blind, case-controlled study. Eur J Obstet Gynecol Reprod Biol. 2017 Oct;217:29-33. doi: 10.1016/j.ejogrb.2017.08.020. Epub 2017 Aug 18.
- Background: PubMed 25551952Mugita M, Kawahara R, Tamai Y, Yamasaki K, Okuno S, Hanada R, Inaoka M, Funato T. Effectiveness of ultrasound-guided transversus abdominis plane block and rectus sheath block in pain control and recovery after gynecological transumbilical single-incision laparoscopic surgery. Clin Exp Obstet Gynecol. 2014;41(6):627-32.
- Individual participant dataSharing planned: No. For our study "Effects of Preoperative Bilateral Rectus Sheath Block Guided by Ultrasound on Analgesic Efficacy and Recovery in Gynecological Single-Port Laparoscopy," we have decided not to share Individual Participant Data (IPD). This decision is due to privacy concerns, data security requirements, ethical approval limitations, legal restrictions, and the study's design which did not accommodate data sharing. We believe this aligns with ethical standards and operational capabilities.
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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.
Fei Jia, BS study chair
Chengdu Jinjiang District Women & Children Health 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 in people with Gynecological Laparoscopy and Postoperative Pain, run by Chengdu Jinjiang Maternity and Child Health Hospital at 1 site in China.
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 5 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 Mar 2025. 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 China. 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?
Postoperative Pain Control (time frame: 48 hours post-surgery). 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 NCT06862947, which also lists 6 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 6 Mar 2025.