Transversus Abdominis Plane Block Plus Quadratus Lumborum Block or Retrolaminar Block of Multiple Injections for Postoperative Analgesia Following Laparoscopic Colorectal Surgery

NCT05416866 | Unknown Phase 4 DMC FDA Drug FDA Device

• 1 other identifier: GanSu Province
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief Summary

Our hypothesis was that transversus abdominis plane block plus retrolaminar block would reduce postoperative sufentanil consumption and provide superior analgesia compared with transversus abdominis plane block plus quadratus lumborum block for laparoscopic colorectal surgery.

Conditions

Quadratus Lumborum Block; Analgesia; Laparoscopic; Colorectal

Outcome Measures

Primary Outcomes (1)

• the cumulative consumption of sufentanil

  the outcome in micrograms

  24 hours after nerves block

Secondary Outcomes (11)

• the patient's mean arterial pressure (MAP), HR at rest and during movement at 1, 2, 4, 6, 8, 12, 18, 24 after nerves block

  the time for completion of nerves block was time 0

• cumulative sufentanil consumption at predetermined time intervals

  within 24 hour after nerves block

• time until the earliest single patient-controlled analgesia (PCA) dose of sufentanil

  within 24 hour after nerves block

• the number of PCA press

  within 24 hour after nerves block

• time until the earliest rescue analgesia and antiemetic

  within 24 hour after nerves block

Study Arms (2)

TR group

EXPERIMENTAL

ultrasound-guided transversus abdominis plane block with 20 ml mixture 0.20% ropivacaine + dexamethasone 5 mg and retrolaminar block with 30-40 ml mixture 0.20% ropivacaine + dexamethasone 5 mg

Procedure: Retrolaminar block on the operative side; Procedure: Transversus abdominis plane block on the nonoperative side

TQ group

EXPERIMENTAL

ultrasound-guided transversus abdominis plane block with 20 ml mixture 0.20% ropivacaine + dexamethasone 5 mg and quadratus lumborum block with 30 ml mixture 0.20% ropivacaine + dexamethasone 5 mg

Procedure: Quadratus lumborum block on the operative side; Procedure: Transversus abdominis plane block on the nonoperative side

Interventions

Retrolaminar block on the operative side PROCEDURE

After the skin near the puncture site was disinfected, 2ml of 1% lidocaine was injected into the puncture site for local infiltration. The needle was inserted beneath the ultrasound probe using an in-plane orientation to contact the lamina of the T8-T11 vertebra. Then we retracted the tip of needle to the lamina about 1 mm and withdrew to make sure that there was no blood or cerebrospinal fluid. Then, 30-40 mL mixture was injected posterior to the lamina of T8-T11.

TR group

Quadratus lumborum block on the operative side PROCEDURE

In our study, we applied a transmuscular approach to the QLB. After the patients were placed in the lateral position, the skin near the puncture site was disinfected, a low-frequency (3-5 MHz), curvilinear probe is used and is located vertical to the iliac crest at the posterior axillary line to find the Shamrock sign. After the local infiltration for puncture site, the 22-G needle is then inserted in plane and directed to the QL muscle. After the proper position of the needle tip between the psoas major muscle and the QL muscle is confirmed, 30 ml mixture is injected into the interfascial plane.

TQ group

Transversus abdominis plane block on the nonoperative side PROCEDURE

After placing the patients in the supine position, the skin was disinfected. A linear probe was placed in the transverse plane at the midaxillary line between the lower costal margin and iliac crest. When the external oblique, internal oblique, and transversus abdominis muscles were observed, 2ml of 1% lidocaine was injected into the puncture site for local infiltration.Then, a 22-gauge, 80-mm needle was advanced using an in-plane technique in an anteromedial to posterolateral direction toward the TAP (the fascial plane between the internal oblique and transversus abdominis muscles). After the correct position of the needle tip was verified, 20 ml mixture was injected into the TAP. The ultrasound showed that the local anesthetic separated the internal oblique and transversus abdominis muscles, confirming the success of the block.

TQ group; TR group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• American Society of Anesthesiologists (ASA) physical status I-II class
• Colorectal cancer patients
• and 80 years old
• Elective laparoscopic colorectal surgery

You may not qualify if:

• serious complications associated with other systems:
• severe cardiac insufficiency
• renal failure
• hepatic encephalopathy
• infection in the block injection area
• coagulopathy
• a known allergy to local anesthetics
• a previous history of tranquilizer or opioid abuse,
• body mass index (BMI) greater than 30 kg/m2 or less than 18 kg/m2,
• inability to cooperate with the assessment of visual analogue scale (VAS) pain scores
• refusal to participate in the study

Sponsors & Collaborators

• dong zhang: lead

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Except the regional anesthesiologist who performed the blocks, patients, surgeons, theatre anesthesiologists, ward staff, caregivers, and the outcome assessor were unaware of group allocation. The regional anesthesiologist was not involved in the other parts of the study. All data was collected by personnel blinded to the patient group allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Anesthesiologist

Model Details: A randomized, double-blind, controlled trial

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 14, 2022
• Study Start: June 20, 2022
• Primary Completion: November 20, 2022
• Study Completion: December 30, 2022
• Last Updated: June 14, 2022

Record last verified: 2022-06