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

NCT ID: NCT02431065

Last Updated: 2015-05-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2017-05-31

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

Conditions

Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 3, Direct injection group

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 Type: EXPERIMENTAL

Rectus sheath block

Intervention Type: PROCEDURE

Local anesthetics (Ropivacaine 0.75% 10ml) or normal saline (10ml) will be injected in the rectus sheath via different methods:

1. 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.

2. 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.

3. 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.

Ropivacaine

Intervention Type: DRUG

Local anesthetics (Ropivacaine 0.75% 10ml) or normal saline (10ml) will be injected in the rectus sheath via different methods:

1. 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.

2. 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.

3. 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.

Group 2, ultrasonography group

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 Type: ACTIVE_COMPARATOR

Rectus sheath block

Intervention Type: PROCEDURE

Local anesthetics (Ropivacaine 0.75% 10ml) or normal saline (10ml) will be injected in the rectus sheath via different methods:

1. 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.

2. 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.

3. 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.

Ropivacaine

Intervention Type: DRUG

Local anesthetics (Ropivacaine 0.75% 10ml) or normal saline (10ml) will be injected in the rectus sheath via different methods:

1. 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.

2. 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.

3. 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.

Group 1

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 Type: PLACEBO_COMPARATOR

Rectus sheath block

Intervention Type: PROCEDURE

Local anesthetics (Ropivacaine 0.75% 10ml) or normal saline (10ml) will be injected in the rectus sheath via different methods:

1. 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.

2. 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.

3. 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.

Normal saline

Intervention Type: OTHER

Local anesthetics (Ropivacaine 0.75% 10ml) or normal saline (10ml) will be injected in the rectus sheath via different methods:

1. 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.

2. 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.

3. 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.

Interventions

Rectus sheath block

Local anesthetics (Ropivacaine 0.75% 10ml) or normal saline (10ml) will be injected in the rectus sheath via different methods:

1. 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.

2. 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.

3. 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.

Intervention Type: PROCEDURE

Ropivacaine

Local anesthetics (Ropivacaine 0.75% 10ml) or normal saline (10ml) will be injected in the rectus sheath via different methods:

1. 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.

2. 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.

3. 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.

Intervention Type: DRUG

Normal saline

Local anesthetics (Ropivacaine 0.75% 10ml) or normal saline (10ml) will be injected in the rectus sheath via different methods:

1. 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.

2. 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.

3. 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.

Intervention Type: OTHER

Other Intervention Names

anesthesia; surgery; No intervention

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Chungnam National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Heon-Jong Yoo

Clinical Vice professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Heon Jong Yoo, MD. PhD

Role: PRINCIPAL_INVESTIGATOR

Chung Nam National University Hospital, clinical vice professor

Central Contacts

Heon Jong Yoo

Role: CONTACT

bell4184@cnuh.co.kr

82-42-280-8277

References

Crosbie EJ, Massiah NS, Achiampong JY, Dolling S, Slade RJ. The surgical rectus sheath block for post-operative analgesia: a modern approach to an established technique. Eur J Obstet Gynecol Reprod Biol. 2012 Feb;160(2):196-200. doi: 10.1016/j.ejogrb.2011.10.015. Epub 2011 Nov 21.

Reference Type: BACKGROUND

PMID: 22104479 (View on PubMed)

Osaka Y, Kashiwagi M, Nagatsuka Y, Oosaku M, Hirose C. [Ultrasound-guided rectus sheath block for upper abdominal surgery]. Masui. 2010 Aug;59(8):1039-41. Japanese.

Reference Type: BACKGROUND

PMID: 20715537 (View on PubMed)

Other Identifiers

GyAne-1

Identifier Type: -

Identifier Source: org_study_id