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Ultrasound-guided Bilateral Rectus Sheath Block for Robotic Single-port Gynecologic Surgery

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ClinicalTrials.gov Identifier: NCT02450084
Recruitment Status : Completed
First Posted : May 21, 2015
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
Youn Jin Kim, Ewha Womans University Mokdong Hospital

Study Description
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Brief 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 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.

Condition or disease Intervention/treatment Phase
Gynecologic Disease Procedure: Rectus sheath block Drug: Ropivacaine Other: Bandage Drug: IV-PCA containing Fentanyl Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Postoperative Analgesic Effects of Ultrasound-guided Bilateral Rectus Sheath Block for Robotic Single-port Gynecologic Surgery
Study Start Date : May 2015
Actual Primary Completion Date : January 31, 2017
Actual Study Completion Date : January 31, 2017

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Rectus sheath block
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.
 Procedure: Rectus sheath block
Ultrasound-guided bilateral rectus sheath block of RSB group using 0.25% Ropivacaine
Other Name: RSB

Drug: Ropivacaine
Ultrasound-guided bilateral rectus sheath block of RSB group using 0.25% Ropivacaine
Other Name: Naropin

Other: Bandage
After the surgery, a bandage will be attached on injection site where is same as the incision site of surgery.

Drug: IV-PCA containing Fentanyl
All patients will use total 100 ml of IV-PCA containing 800 µg of fentanyl for 48 hours postoperatively.
Other Name: Intravenous patient controlled analgesia using fentanyl
Sham Comparator: Control
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.
 Other: Bandage
After the surgery, a bandage will be attached on injection site where is same as the incision site of surgery.

Drug: IV-PCA containing Fentanyl
All patients will use total 100 ml of IV-PCA containing 800 µg of fentanyl for 48 hours postoperatively.
Other Name: Intravenous patient controlled analgesia using fentanyl


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Total opioids use [ Time Frame: 0, 1, 6, 12, 24, 48 hours postoperatively ]
    Total dosage of injected fentanyl through IV-PCA

  2. Time to first rescue analgesic request [ Time Frame: 48 hours postoperatively ]
    How long it takes postoperative time to first additional analgesic drug injection by patient's request

  3. Verbal numerical rating scale [ Time Frame: 0, 1, 12, 24, 48 hours postoperatively ]
    Postoperative pain on each time point which is expressed by verbal numerical rating scale (0 ~ 10)


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Robotic single-port gynecologic surgery
  • American society of Anesthesiologists (ASA) physical status classification I-II
  • Age: 21-60

Exclusion Criteria:

  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02450084


Locations
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Korea, Republic of
Ewha Womans University Mokdong Hospital
Seoul, Korea, Republic of, 158-710
Sponsors and Collaborators
Ewha Womans University Mokdong Hospital
Investigators
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Principal Investigator: Youn Jin Kim, MD, PhD Ewha Womans University Mokdong Hospital
More Information
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Responsible Party: Youn Jin Kim, Associate Professor of Anesthesiology and Pain Medicine, Ewha Womans University Mokdong Hospital
ClinicalTrials.gov Identifier: NCT02450084    
Other Study ID Numbers: EUMC 2015-01-024-002
First Posted: May 21, 2015    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Fentanyl
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
 Peripheral Nervous System Agents
Analgesics, Opioid
Narcotics
Analgesics
Adjuvants, Anesthesia
Anesthetics, Intravenous
Anesthetics, General