Trunks Body Blocks for Postoperative Analgesia in Abdominal Surgery

Sponsor

Diskapi Teaching and Research Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT04143542

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Days)

Study Details

Study Description

Brief Summary

This study aims to the comparison of Quadratus Lumborum Block 2 and Transversus Abdominis Plan Block for Postoperative Analgesia in Abdominal Surgery

Condition or Disease	Intervention/Treatment	Phase
Analgesia Block	Procedure: trunk blocks	N/A

Detailed Description

This study aims to the comparison of Quadratus Lumborum Block 2 and Transversus Abdominis Plan Block for Postoperative Analgesia in Abdominal Surgery.

In abdominal surgeries, USG guided body blocks are performed for postoperative analgesia. For this purpose, Transversus Abdominis Plan Block (TAPB) and Quadratus Lumborum Block 2 (QLB 2) are frequently used blocks.

The aim of this study was to evaluate for postoperative analgesia of preoperative trunk blocks, intraoperative hemodynamic changes with the unblocked control group, Modified Aldrete Recovery Score (MADS) 9 in the recovery unit, Numerical pain scale (NRS) in the service department, It is aimed to examine and compare the time it reaches on the 1st, 2nd and 24th hours after this period. Patient satisfaction is also evaluated in the ward.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

Comparison of Quadratus Lumborum Block 2 and Transversus Abdominis Plan Block for Postoperative Analgesia in Abdominal Surgery

Anticipated Study Start Date :

Apr 23, 2020

Anticipated Primary Completion Date :

May 1, 2020

Anticipated Study Completion Date :

May 5, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Groups Q In abdominal surgeries, USG guided Quadratus Lumborum 2 blocks are performed for postoperative analgesia. For this purpose, Quadratus Lumborum Block 2 (QLB 2) are frequently used blocks. The aim to this study was to evaluate the postoperative analgesia of preoperative trunk blocks, intraoperative hemodynamic changes with the unblocked control group, Modified Aldrete Recovery Score (MADS) 9 in the recovery unit, Numerical pain scale (NRS) in the service department, It is aimed to examine and compare the time it reaches on the 1st, 2nd and 24th hours after this period. Patient satisfaction is also evaluated in the ward.	Procedure: trunk blocks Comparison of trunks blocks and control groups for Postoperative Analgesia in Abdominal Surgery
Experimental: Groups T In abdominal surgeries, USG guided TAP blocks are performed for postoperative analgesia. For this purpose, TAP blocks are frequently used blocks. The aim to this study was to evaluate the postoperative analgesia of preoperative trunk blocks, intraoperative hemodynamic changes with the unblocked control group, Modified Aldrete Recovery Score (MADS) 9 in the recovery unit, Numerical pain scale (NRS) in the service department, It is aimed to examine and compare the time it reaches on the 1st, 2nd and 24th hours after this period. Patient satisfaction is also evaluated in the ward.	Procedure: trunk blocks Comparison of trunks blocks and control groups for Postoperative Analgesia in Abdominal Surgery
No Intervention: Groups C There was no intervention. All patients will receive pre-oxygenation with O2 100% for 3 min. Anesthesia will be induced by using fentanyl 1μg/kg, propofol 1.5-2 mg/kg, and atracurium 0.5 mg/kg will be used for muscle relaxation. Anesthesia will be maintained by controlled ventilation with oxygen and air (50:50) with the target of EtCO2≈ 35-40 mmHg, isoflurane 1:1.5 minimum alveolar concentration (MAC). Anesthesia will be discontinued and tracheal extubation will be done once the patient fulfills the extubation criteria.Tramadol 100 mg i.v. Before 15 min end of surgery. The patient control analgesia device will administer all patients.

Arm

Intervention/Treatment

Experimental: Groups Q

In abdominal surgeries, USG guided Quadratus Lumborum 2 blocks are performed for postoperative analgesia. For this purpose, Quadratus Lumborum Block 2 (QLB 2) are frequently used blocks. The aim to this study was to evaluate the postoperative analgesia of preoperative trunk blocks, intraoperative hemodynamic changes with the unblocked control group, Modified Aldrete Recovery Score (MADS) 9 in the recovery unit, Numerical pain scale (NRS) in the service department, It is aimed to examine and compare the time it reaches on the 1st, 2nd and 24th hours after this period. Patient satisfaction is also evaluated in the ward.

Procedure: trunk blocks

Comparison of trunks blocks and control groups for Postoperative Analgesia in Abdominal Surgery

Experimental: Groups T

In abdominal surgeries, USG guided TAP blocks are performed for postoperative analgesia. For this purpose, TAP blocks are frequently used blocks. The aim to this study was to evaluate the postoperative analgesia of preoperative trunk blocks, intraoperative hemodynamic changes with the unblocked control group, Modified Aldrete Recovery Score (MADS) 9 in the recovery unit, Numerical pain scale (NRS) in the service department, It is aimed to examine and compare the time it reaches on the 1st, 2nd and 24th hours after this period. Patient satisfaction is also evaluated in the ward.

Procedure: trunk blocks

Comparison of trunks blocks and control groups for Postoperative Analgesia in Abdominal Surgery

No Intervention: Groups C

There was no intervention. All patients will receive pre-oxygenation with O2 100% for 3 min. Anesthesia will be induced by using fentanyl 1μg/kg, propofol 1.5-2 mg/kg, and atracurium 0.5 mg/kg will be used for muscle relaxation. Anesthesia will be maintained by controlled ventilation with oxygen and air (50:50) with the target of EtCO2≈ 35-40 mmHg, isoflurane 1:1.5 minimum alveolar concentration (MAC). Anesthesia will be discontinued and tracheal extubation will be done once the patient fulfills the extubation criteria.Tramadol 100 mg i.v. Before 15 min end of surgery. The patient control analgesia device will administer all patients.

Outcome Measures

Primary Outcome Measures

Postoperative pain [1 hours]
The degree of pain will be measured with a numerical rating scale (NRS). All patients' postoperative pain logarithmic rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
Postoperative pain [2 hours]
The degree of pain will be measured with numerical rating scale (NRS). All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
Postoperative pain [4 hours]
The degree of pain will be measured with numerical rating scale (NRS). All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.
The degree of postoperative pain [24 hours]
The degree of pain will be measured with a numerical rating scale (NRS). All patients' postoperative pain numerical rating scale (NRS-numeric rating scale; 0 = absence of pain, 10 = unbearable pain) will be recorded in both groups.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Abdominal surgery

Exclusion Criteria:

Cardio-respiratory disease Anti-inflammatory treatment Cognitive disorders Written consent form haven't get history of relevant drug allergy infection of the skin at the site of the needle puncture area coagulopathy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Diskapi Teaching and Research Hospital

Investigators

Study Director: Ceyda Ozhan Caparlar, Diskapi Yildirim Beyazit Education and Research Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ceyda Ozhan Caparlar, md, Diskapi Teaching and Research Hospital

ClinicalTrials.gov Identifier:

NCT04143542

Other Study ID Numbers:

QLB 2

First Posted:

Oct 29, 2019

Last Update Posted:

Apr 24, 2020

Last Verified:

Apr 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ceyda Ozhan Caparlar, md, Diskapi Teaching and Research Hospital

quadratus lumborum block

transversus abdominis block

postoperative analgesia

Additional relevant MeSH terms:

Agnosia

Study Results

No Results Posted as of Apr 24, 2020