AdjuvantQLB: Evaluation of Effectivity of Quadratus Lumborum Blocks With Adjuvant

Sponsor

Gaziosmanpasa Research and Education Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT06028061

Collaborator

(none)

Enrollment

Location

Arms

5.1

Anticipated Duration (Months)

11.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

İn recent years abdominal wall blocks are widely used for to reduce intraoperative anesthetic recuirements and postoperative analgesia.Quadratus lumborum blocks are one of the abdominal wall blocks to used at laparoscopic cholecystectomy.Conventionally adjuvants used to improve and prolonged the effect of periferic nerve, spinal and abdominal blocks.İn this study investigators will evaluate the effectiveness of adjuvants at quatratus lumborum block at patient underwent laparoscopic cholecystectomy.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain Management Postoperative Pain Analgesia Nerve Blocks Nerve Block Duration Cholecystectomy	Procedure: Quadratus Lumborum Block III Procedure: Quadratus lumborum block III with Adjuvant	N/A

Detailed Description

Laparoscopic approach in cholecystectomy surgery is frequently preferred because of its advantages in systemic complications, morbidity, mortality and hospital stay. Pain is one of the important causes of late discharge after surgery. Laparoscopic cholecystectomy surgery requires a multimodal analgesia approach because of its multiple pain components.Regional analgesia techniques are effective in reducing the side effects such as intraoperative opioid use, postoperative pain and nausea and vomiting. Quadratus lumborum III block is a regional technique performed for multimodal analgesia.Adjuvants are known to improve the analgesic efficacy and prolonge the effect of the periferic and central nerve blocks.The aim of this study is to determine the effectiveness of adding adjuvant at quadratus lumborum block for patients who underwent laparoscopic cholecystectomy.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Primary Purpose:

Supportive Care

Official Title:

Evaluation of The Postoperative Analgesic Effectivity of Quadratus Lumborum Block III With Adjuvant on Patients Undergoing Laparoscopic Cholecystectomy Surgery : A Randomised Controled Study

Actual Study Start Date :

Jun 12, 2023

Anticipated Primary Completion Date :

Sep 15, 2023

Anticipated Study Completion Date :

Nov 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Quadratus lumborum block Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine is injected. The same is done to the opposite side.	Procedure: Quadratus Lumborum Block III Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine is injected. The same is done to the opposite side.
Active Comparator: Quadratus Lumborum Block with adjuvant Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine and 4mg dexamethasone is injected. The same is done to the opposite side.	Procedure: Quadratus lumborum block III with Adjuvant Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine and 4mg dexamethasone is injected. The same is done to the opposite side.

Arm

Intervention/Treatment

Active Comparator: Quadratus lumborum block

Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine is injected. The same is done to the opposite side.

Procedure: Quadratus Lumborum Block III

Active Comparator: Quadratus Lumborum Block with adjuvant

Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine and 4mg dexamethasone is injected. The same is done to the opposite side.

Procedure: Quadratus lumborum block III with Adjuvant

Patients are placed in the lateral decubitus position. The area where the block will be applied is disinfected with povidine iodine. A convex ultrasound probe is placed on the midaxillary line above the iliac crest. By visualizing the transverse process adjacent to the psoas major and quadratus lumborum muscles, using the in-plane technique, using a 22 gauge 80 mm peripheral block needle after negative aspiration into the anterior layer of the thoracolumbar fascia anterior to the quadratus lumborum muscle muscle, 0.5-1 ml of serum After observing hydrodissection with physiological, 20 ml of 0.25% bupivacaine and 4mg dexamethasone is injected. The same is done to the opposite side.

Outcome Measures

Primary Outcome Measures

Total amount of opioid requirements [within 24 hours after the surgery]
The total tramadol use of the patients in 24 hours will be recorded.
rescue analgesia [within 24 hours after the surgery]
The rescue analgesia requirement and time of the need of the rescue analgesia requirement

Secondary Outcome Measures

intraoperative remifentanil consumption [during operation procedure]]
The total remifentanil use to be used in the maintenance of 0.05-0.2 mcg/kg remifentanil will be recorded by titration according to the hemodynamic data of the intraoperative patients.
Visual Analogue Scale values [at 1st, 4th,8th 12th and 24th hours after the surgery]]
Visual Analogue Scale is a scale of 0-10 cm in length, expressed by non-standard verbal descriptors (no pain-unbearable pain..) indicating the limits of pain intensity on both sides, horizontally or vertically.
side effects such as nausea, vomiting and shoulder pain [within 24 hours after the surgery]
The incidence of postoperative side effects such as nausea, vomiting and shoulder pain will be evaluated.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria: American Society of Anesthesiologists physical statusⅠ-II

Exclusion Criteria:

Inclusion Criteria:
18-65 years of age
American Society of Anesthesiologists physical statusⅠ-II

Exclusion Criteria:

local anesthetic allergy
Infection at the procedure site Body Mass Index >35 kg/m2 Anticoagulant use with bleeding disorder Chronic analgesia and opioid use with mental and psychiatric disorders Contraindications to regional anesthesia several lung and heart disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gaziosmanpasa Research and Education Hospital	İ̇stanbul	Marmara	Turkey	34255

Sponsors and Collaborators

Gaziosmanpasa Research and Education Hospital

Investigators

Principal Investigator: SERPİL SEHİRLİOGLU, MD, Gaziosmanpasa Research and Education Hospital
Principal Investigator: BATUHAN BURHAN, MD, Gaziosmanpasa Research and Education Hospital
Study Director: DONDU GENC MORALAR, MD, Gaziosmanpasa Research and Education Hospital