Ultrasonography-guided and Surgical Rectus Sheath Block in Single-port Access Laparoscopy

Phase 2

• Conditions: Pain
• Interventions: Procedure: Rectus sheath block; Other: Normal saline; Drug: Ropivacaine

• Registration Number: NCT02431065
• Lead Sponsor: Chungnam National University Hospital

Brief Summary

Rectus sheath block is effective in reducing pain in the peri-umbilical region, and the use of ultrasonography is recommended to perform the block at the precise location. Recently, intra-operative rectus sheath block has also been introduced without the aid of ultrasonography. However, no study has not yet compared the analgesic effects of these two different approaches (ultrasonography-guided vs direct surgical). Thus, the aim of our study is to compare the effect of ultrasonography-guided and direct-surgical rectus sheath block after single-port access laparoscopy in benign ovary cyst patients.

Detailed Description

This is a randomized, prospective study comparing the analgesic effects of ultrasonography-guided and direct-surgical rectus sheath block after single-port access laparoscopy in benign ovary cyst patients.

Patients will be randomly divided into 3 groups based on the procedure: control group, ultrasonography group and direct injection group. Each group consists of 30 patients.

* Control group Normal saline 10mL will be injected under ultrasonography guidance into the right, left rectus sheath at the end of the operation before emergence from general anesthesia.

* Ultrasonography group Local anesthetic (Ropivacaine 0.75% 10 mL) will be injected under ultrasonography guidance into the right left rectus sheath at the end of the operation before emergence from general anesthesia.

* Direct injection group Local anesthetic (Ropivacaine 0.75% 10 mL) will be injected under direct visualization into the right, left rectus sheath at the end of the operation before emergence from general anesthesia.

Analgesic efficiency will be assessed using the VAS (visual analogue scale) pain scale and the total amount of self-administered fentanyl via PCA (patient controlled analgesia) devices at multiple time scales (1, 6, 10, 24 and 48 hours after surgery). We will also compare the incidence of fentanyl complications, such as nausea, vomiting, pruritus and dizziness

Study Timeline

• Status Verified: 2015-04
• Study First Submitted: 2015-04-17
• Study First Submitted QC: 2015-04-29
• Study First Posted: 2015-04-30
• Last Update Submitted: 2015-04-30
• Study Start: 2015-05
• Last Update Posted: 2015-05-04
• Primary Completion: 2016-05
• Study Completion: 2017-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

1. Patients scheduled for a single port laparoscopic surgery at Chung Nam University hospital due to benign tumor of the ovary or the fallopian tube
2. Between age of twenty to seventy
3. Patients with a physical rating of 1 or 2 according to the American Anesthesiology guidelines
4. Patients who have not had laparoscopic surgery within two months

Exclusion Criteria

1. Hysterectomy via single port laparoscopic surgery
2. Patients with chronic pelvic pain
3. Abdominal pain of unknown origin
4. Suspected malignant tumor
5. Diagnosed with malignant tumor of any origin
6. Patients currently taking psychiatric medicine
7. Pregnancy
8. Patients with a history of hypersensitivity to amide type local anesthetics
9. Patients with a history of hypersensitivity to opioid
10. Risk of bleeding
11. Unable to comprehend or does not agree to the consent form

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 3, Direct injection group	Rectus sheath block	Test group 2, Rectus sheath block will be performed under direct visualization. Ropivacaine (0.75%, 10ml) will be directly injected into the right and left rectus sheath at the end of the operation.
Group 2, ultrasonography group	Rectus sheath block	Test group 1, Rectus sheath block will be performed under sonographic guidance. Ropivacaine (0.75%, 10ml) will be injected into the right and left rectus sheath under ultrasonographic guidance at the end of the operation.
Group 1	Rectus sheath block	Control group, Rectus sheath block will be performed under sonographic guidance. Normal saline 10 ml will be injected into the right, left rectus sheath under ultrasonography guidance at the end of the operation.
Group 1	Normal saline	Control group, Rectus sheath block will be performed under sonographic guidance. Normal saline 10 ml will be injected into the right, left rectus sheath under ultrasonography guidance at the end of the operation.
Group 2, ultrasonography group	Ropivacaine	Test group 1, Rectus sheath block will be performed under sonographic guidance. Ropivacaine (0.75%, 10ml) will be injected into the right and left rectus sheath under ultrasonographic guidance at the end of the operation.
Group 3, Direct injection group	Ropivacaine	Test group 2, Rectus sheath block will be performed under direct visualization. Ropivacaine (0.75%, 10ml) will be directly injected into the right and left rectus sheath at the end of the operation.

Primary Outcome Measures

Name	Time	Method
The intensity of pain as assessed by Dose of fentanyl(opioid)	within 24 hours of surgery	Dose of fentanyl(opioid) self-administered by the patients within 24 hours of surgery

Secondary Outcome Measures

Name	Time	Method
Incident rate of side effects of fentanyl	within 24 hours of surgery	Incident rate of side effects of fentanyl including nausea and vomiting by the patients within 24 hours of surgery