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

NCT02431065 | Unknown Phase 2 DMC

• 1 other identifier: GyAne-1
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain

Keywords

Rectus sheath block; Single port laparoscopy

Outcome Measures

Primary Outcomes (1)

• The intensity of pain as assessed by Dose of fentanyl(opioid)

  Dose of fentanyl(opioid) self-administered by the patients within 24 hours of surgery

  within 24 hours of surgery

Secondary Outcomes (1)

• Incident rate of side effects of fentanyl

  within 24 hours of surgery

Study Arms (3)

Group 3, Direct injection group

EXPERIMENTAL

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.

Procedure: Rectus sheath block; Drug: Ropivacaine

Group 2, ultrasonography group

ACTIVE COMPARATOR

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.

Procedure: Rectus sheath block; Drug: Ropivacaine

Group 1

PLACEBO COMPARATOR

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.

Procedure: Rectus sheath block; Other: Normal saline

Interventions

Rectus sheath block 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.

Also known as: anesthesia

Group 1; Group 2, ultrasonography group; Group 3, Direct injection group

Ropivacaine 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.

Also known as: surgery

Group 2, ultrasonography group; Group 3, Direct injection group

Normal saline 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.

Also known as: No intervention

Group 1

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Hysterectomy via single port laparoscopic surgery
• Patients with chronic pelvic pain
• Abdominal pain of unknown origin
• Suspected malignant tumor
• Diagnosed with malignant tumor of any origin
• Patients currently taking psychiatric medicine
• Pregnancy
• Patients with a history of hypersensitivity to amide type local anesthetics
• Patients with a history of hypersensitivity to opioid
• Risk of bleeding
• Unable to comprehend or does not agree to the consent form

Sponsors & Collaborators

• Chungnam National University Hospital: lead

Related Publications (2)

• 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.

  PMID: 22104479 BACKGROUND

• 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.

  PMID: 20715537 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Anesthesia; Ropivacaine; Surgical Procedures, Operative; Saline Solution

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthesia and Analgesia; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Heon Jong Yoo, MD. PhD

  Chung Nam National University Hospital, clinical vice professor

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heon Jong Yoo

CONTACT

82-42-280-8277; bell4184@cnuh.co.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Vice professor

Study Record Dates

• First Submitted: April 17, 2015
• First Posted: April 30, 2015
• Study Start: May 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2017
• Last Updated: May 4, 2015

Record last verified: 2015-04