Application of Rectus Sheath Block based-on Incision in Upper Abdominal Surgery

NCT04306159 | Completed DMC

• 1 other identifier: 201911
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

General anesthesia combined subcostal transversus abdominis plane (TAP)or rectus sheath block (RSB)can significantly reduce the use of opiates in minimally invasive surgery.However, similar reduction was not observed in open abdominal surgery during perioperative period.Therefore, the investigators should try to improve the blocking methods to reduce the side effects of a large number of opiates. Based on the range and its analgesic effect of various nerve block is obviously related to the injection site of local anesthetics, this randomized controlled study hypothesized that modified RSB under the guidance of surgical incision may be more effective in inhibiting the harmful stimulation of surgery.

Conditions

Opioid Consumption

Outcome Measures

Primary Outcomes (2)

• Opiate consumption

  Remifentanil consumption

  From the beginning to the end of anesthesia,up to 6 hours.

• Tumor recurrence rate

  Tumor recurrence rate after surgery

  1-year after surgery

Secondary Outcomes (20)

• Opiate consumption

  From the end of anesthesia to 48 hours after surgery, up to 2 days.

• Pain scores

  2 hours after surgery

• Pain scores

  6 hours after surgery

• Pain scores

  12 hours after surgery

• Pain scores

  24 hours after surgery

Study Arms (3)

General anesthesia

SHAM COMPARATOR

Basal blood pressure and heart rate were recorded after midazolam administration of 0.02 mg/kg. Anesthesia was induced with sufentanil 0.4 μg/kg and propofol 2-2.5 mg/kg, IV route. An IV bolus of cisatracurium 0.1 mg/kg IV was given to facilitate tracheal intubation. Anesthesia was maintained with propofol 4-6 mg/kg/h combined dexmedetomidine 0.2 μg/kg/h(after 0.2 μg/kg/h loading dose within 15min)by bispectral index (BIS) 40-60 and additional bolus doses of remifentanil 0.2-0.5 μg/kg/min to keep arterial pressure values around 20% below baseline values. Sufentanil 0.1-0.2 μg/kg and flurbiprofen 100mg was administrated once the abdomen was closed, then a patient controlled analgesia pump was used. No RSB was performed.

Other: General anesthesia

Subcostal TAP combined with General anesthesia

EXPERIMENTAL

After induction, TAP was performed. The transversus abdominis plane is imaged with the ultrasound probe obliquely on the upper abdominal wall, along the subcostal margin near the midline.The needle tip was advanced to the desired position where 20 mL 0.375%ropivacaine(Dexamethasone 5mg was added)were injected.The technique is repeated on the opposite side. Anesthesia method and management was same as general anesthesia group.

Procedure: Subcostal TAP

Modified RSB combined with General anesthesia

EXPERIMENTAL

After induction, Modified RSB was performed based on midline incision-guided. The rectus muscle is imaged with the ultrasound probe in a transverse orientation below the xiphisternum and above the umbilicus.The needle tip was advanced to the two desired position where 10 mL ropivacaine 0.375% were injected causing hydrodissection of the rectus muscle away from the posterior rectus sheath.The technique is repeated on the opposite side.Anesthesia method and management was same as general anesthesia group.

Procedure: Modified RSB

Interventions

Subcostal TAP PROCEDURE

Subcostal transversus abdominis plane block

Subcostal TAP combined with General anesthesia

Modified RSB PROCEDURE

Rectus Sheath Block under the guidance of surgical incision

Modified RSB combined with General anesthesia

General anesthesia OTHER

Traditional general anesthesia management

General anesthesia

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18-85 years
• Anesthesiologists (ASA) risk classification I to IV
• Scheduled to undergo midline incision of upper abdomen (From xiphoid to navel )

You may not qualify if:

• Patient refusal
• Any contraindications to regional techniques (allergy to local anesthetics, infection around the site of the block, and coagulation disorder)
• History of analgesics dependence
• Any difficulty with communication
• Allergy to the study drugs
• Heat rate \< 50 beats/minutes or II-III Atrioventricular block
• Previous open surgery
• Previous definite history of malignant tumor
• Who had an estimated intraoperative blood loss of more than 500 mL

Sponsors & Collaborators

• The First Affiliated Hospital of Anhui Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

MeSH Terms

Interventions

Anesthesia, General

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Guanghong Xu, MD.PHD

  The First Affiliated Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2020
• First Posted: March 12, 2020
• Study Start: March 15, 2020
• Primary Completion: July 30, 2021
• Study Completion: August 16, 2021
• Last Updated: August 24, 2021

Record last verified: 2020-03

Locations

CN (1)