TMQLB Versus TPVB for Acute Pain and Quality of Recovery After Laparoscopic Renal Surgery

NCT ID: NCT03414281

Last Updated: 2020-03-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-04
• Study Completion Date: 2019-05-01

Brief Summary

This trial is a prospective, randomized, single-center, open-label, parallel-arm, blinded-analysis trial, the objective of which is to evaluate the effect of transmuscular quadratus lumborum block (TMQLB) in the pain relief and quality of recovery in laparoscopic renal surgery compared with thoracic paravertebral block (TPVB).

Conditions

Nerve Block, Nephrectomy, Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

TMQLB group 1

0.4ml/kg ropivacaine is injected into the interfascial plane between the psoas major and quadratus lumborum muscle using TMQLB approach.

Group Type: EXPERIMENTAL

TMQLB group 1

Intervention Type: PROCEDURE

The patient is placed in the lateral position. The curved (C1-5) probe of Philip CX50 Ultrasound Scanner is used for scan and located vertical to the iliac crest at the posterior axillary line to find the Shamrock sign. 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 quadratus lumborum muscle is confirmed, 0. 4 ml/kg 0.5% ropivacaine with 1: 200,000 adrenaline is injected into the interfascial plane.

Followed by IPCA in the first 48h after surgery: morphine boluses: 1.5-2 mg, lockout time :10 min, 1h limitation: 6-8 mg morphine.

TMQLB group 2

0.6ml/kg ropivacaine is injected into the interfascial plane between the psoas major and quadratus lumborum muscle using TMQLB approach.

Group Type: EXPERIMENTAL

TMQLB group 2

Intervention Type: PROCEDURE

The patient is placed in the lateral position. The curved (C1-5) probe of Philip CX50 Ultrasound Scanner is used for scan and located vertical to the iliac crest at the posterior axillary line to find the Shamrock sign. 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 quadratus lumborum muscle is confirmed, 0. 6 ml/kg 0.5% ropivacaine with 1: 200,000 adrenaline is injected into the interfascial plane.

Followed by IPCA in the first 48h after surgery: morphine boluses: 1.5-2 mg, lockout time :10 min, 1h limitation: 6-8 mg morphine.

TPVB group

0.4ml/kg ropivacaine is injected into the thoracic paravertebral space (T10) using TPVB approach.

Group Type: ACTIVE_COMPARATOR

TPVB

Intervention Type: PROCEDURE

The patient is placed in the lateral position, the spinous processes of T10 are identified and marks are made 2cm lateral to the spinous processes. The linear(L12-3) probe of Philips CX50 is placed transversally at the mark to identify the paravertebral space. Then a 22-G needle is inserted in-plane from lateral to medial and advanced until the tip reached the paravertebral space surrounded by the parietal pleura and the superior costotransverse ligament. 0.4 ml/kg 0.5% ropivacaine with 1: 200,000 adrenaline is injected into the paravertebral space of T10.

Followed by IPCA in the first 48h after surgery: morphine boluses: 1.5-2 mg, lockout time :10 min, 1h limitation: 6-8 mg morphine.

Interventions

TMQLB group 1

The patient is placed in the lateral position. The curved (C1-5) probe of Philip CX50 Ultrasound Scanner is used for scan and located vertical to the iliac crest at the posterior axillary line to find the Shamrock sign. 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 quadratus lumborum muscle is confirmed, 0. 4 ml/kg 0.5% ropivacaine with 1: 200,000 adrenaline is injected into the interfascial plane.

Followed by IPCA in the first 48h after surgery: morphine boluses: 1.5-2 mg, lockout time :10 min, 1h limitation: 6-8 mg morphine.

Intervention Type: PROCEDURE

TMQLB group 2

The patient is placed in the lateral position. The curved (C1-5) probe of Philip CX50 Ultrasound Scanner is used for scan and located vertical to the iliac crest at the posterior axillary line to find the Shamrock sign. 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 quadratus lumborum muscle is confirmed, 0. 6 ml/kg 0.5% ropivacaine with 1: 200,000 adrenaline is injected into the interfascial plane.

Followed by IPCA in the first 48h after surgery: morphine boluses: 1.5-2 mg, lockout time :10 min, 1h limitation: 6-8 mg morphine.

Intervention Type: PROCEDURE

TPVB

The patient is placed in the lateral position, the spinous processes of T10 are identified and marks are made 2cm lateral to the spinous processes. The linear(L12-3) probe of Philips CX50 is placed transversally at the mark to identify the paravertebral space. Then a 22-G needle is inserted in-plane from lateral to medial and advanced until the tip reached the paravertebral space surrounded by the parietal pleura and the superior costotransverse ligament. 0.4 ml/kg 0.5% ropivacaine with 1: 200,000 adrenaline is injected into the paravertebral space of T10.

Followed by IPCA in the first 48h after surgery: morphine boluses: 1.5-2 mg, lockout time :10 min, 1h limitation: 6-8 mg morphine.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 17~80 years of age;
• American Society of Anesthesiologists physical status I-III;
• undergoing laparoscopic nephrectomy.

Exclusion Criteria

• have a known allergy to the anesthetics being used;
• infection at injection site
• coagulopathy or history of anticoagulants use
• chronic analgesics consumption or history of substance abuse
• inability to properly describe postoperative pain or recovery to investigators (e.g., language barrier, neuropsychiatric disorder).

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cui Xulei

OTHER

Sponsor Role: lead

Responsible Party

Cui Xulei

The attending physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Yuguang Huang

Role: STUDY_CHAIR

Peking Union Medical College Hospital

Locations

Xulei CUI

Beijing, Beijing Municipality, China

Countries

China

References

Yuan Q, Cui X, Fei Y, Xu Z, Huang Y. Transmuscular quadratus lumborum block versus thoracic paravertebral block for acute pain and quality of recovery after laparoscopic renal surgery: study protocol for a randomized controlled trial. Trials. 2019 May 20;20(1):276. doi: 10.1186/s13063-019-3359-7.

Reference Type: DERIVED

PMID: 31109368 (View on PubMed)

Other Identifiers

cuixulei5

Identifier Type: -

Identifier Source: org_study_id