Clinical trial NCT02431065: Ultrasonography-guided and Surgical Rectus Sheath Block in Single-port Access Laparoscopy
Official title: Comparing the Analgesic Effects of Ultrasonography-guided and Direct-surgical Rectus Sheath Block in Single-port Access Laparoscopy Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Pain
Keywords: Rectus sheath block
Single port laparoscopy
Lead sponsor: Chungnam National University Hospital
Sponsor class: OTHER
First posted: 2015-04-30
Enrollment: 30
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: The intensity of pain as assessed by Dose of fentanyl(opioid)
timeFrame: within 24 hours of surgery
Secondary outcomes:
measure: Incident rate of side effects of fentanyl
timeFrame: within 24 hours of surgery
Other outcomes:
Locations:
Study officials:
affiliation: Chung Nam National University Hospital, clinical vice professor
name: Heon Jong Yoo, MD. PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.