Dexmedetomidine as an Adjuvant to Local Anesthesia in Quadratus Lumborum Block After Cesarean Delivery

NCT04748224 | Completed DMC

• 1 other identifier: MD-75-2020
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

Brief Summary

Postoperative pain is considered one of the major problems after abdominal operations, so proper pain control is one of the main issues in clinical practice. Cesarean section (CS.) is one of the most common abdominal surgeries and the use of CS. worldwide has increased to unprecedented levels. Effective postoperative analgesia enhances early recovery of the delivered mother, early ambulation, breast feeding and decreases the risk of postoperative thromboembolism. Therefore, Opioids are prescribed routinely for postoperative pain control, but they have many adverse effects such as nausea, vomiting, constipation, excessive sedation, dizziness, respiratory depression, and addiction, so it is important to practice alternative opioid sparing analgesic approaches. Recently, QL block is considered one of the perioperative pain management techniques used in patients undergoing various pelvi-abdominal surgeries. Quadratus Lumborum block inhibits both pain components (somatic and visceral) as a result of local anesthetic spread to the paravertebral spaceA study has been published comparing the analgesic efficacy between QLB and TAP block after cesarean section and proved that QL block II is more effective than TAP Block regarding pain relief and duration of action after CS. Also, Many studies have been published and prove that Combination of adjuvants like (fentanyl, clonidine and MgSo4,etc.) to local anesthetics agents helps in prolonging the analgesic effect and decrease 24hours opiate consumption.one of these adjuvants which used extensively in the regional techniques is dexmedetomidine, which is a selective alpha-2 adrenergic agonist. The optimal dosage of dexmedetomidine to be added to local anesthetics still remains unclear, but in other studies the dose of 0.5 μg/kg is widely used with no postoperative complications. in this double blinded randomized controlled trial, the investigators compare the analgesic efficacy of adding dexmedetomidine to local anesthetic in quadratus lumborum block and their role in reduction postoperative opioid consumption after cesarean section

Conditions

Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

• total amount of morphine consumption

  Measure the total amount of morphine consumption at predetermined time intervals (4, 8, 12, and 24) hrs. after surgery

  up to 24 hours

Secondary Outcomes (1)

• Numerical Rating Scale

  up to 24 hours

Other Outcomes (4)

• ambulation postoperatively

  up to 24 hours

• quadratus lumborum block complications

  up to 24 hours

• sedation score

  up to 24 hours

Study Arms (2)

group A (bupivacaine only)

ACTIVE COMPARATOR

Group A will be injected with 20 ml of 0. 25% bupivacaine in each side

Drug: Bupivacaine 0.25% Injectable Solution

group B (bupivacaine plus dexmedetomidine)

ACTIVE COMPARATOR

Group B will be injected with 20 ml of 0. 25% bupivacaine in each side added to it dexmedetomidine 0.5 μg/kg; (Precedex 100 μg/ml (Hospira, inc, lake forest, USA).

Drug: bupivacaine plus dexmedetomidine

Interventions

Bupivacaine 0.25% Injectable Solution DRUG

a local anesthetic drug

Also known as: marcaine

group A (bupivacaine only)

bupivacaine plus dexmedetomidine DRUG

bupivacaine is a local anesthetic drug plus dexmedetomidine is a new generation highly selective α2-adrenergic receptor (α2-AR) agonist that is associated with sedative and analgesic sparing effects

Also known as: Marcaine plus precedex

group B (bupivacaine plus dexmedetomidine)

Eligibility Criteria

• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for cesarean section under spinal anesthesia.
• Normal uncomplicated pregnancies (ASA II).
• BMI 18.5 to 34.9 kg/m2

You may not qualify if:

• Patient refusal.
• ASA III - IV patients.
• Coagulation disorders.
• Skin lesions or infection at site of proposed needle.
• Known allergy to any of study drugs.
• inability to comprehend or use the verbal rating pain scoring system
• Difficulty in Ultrasonographic identification.
• Opioid abuse.
• BMI \> 35 Kg/m2.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (2)

Faculty of Medicine Cairo University

Cairo, 11956, Egypt

Location

Faculty of Medicine

Cairo, 11956, Egypt

Location

Related Publications (1)

• 1. Snell P, Hicks C. An exploratory study in the UK of the effectiveness of three different pain management regimens for post-cesarean section women. Midwifery. 2006; 22(3):249-61. 2. Betrán A, Ye J, Moller A, et al. The Increasing Trend in Cesarean Section Rates: Global, Regional and National Estimates: 2016;11(2) 3. Gadsden J, Hart S, Santos A. Post-cesarean delivery analgesia. Anesth Analg 2005; 101(5 Suppl): S62-S69. 4. Karlström A, Engström-Olofsson R, Norbergh K, et al. Postoperative pain after cesarean birth affects breastfeeding and infant care. J Obstet Gynecol Neonatal Nurs 2007; 36: 430-40. 5. Stephan B, Parsa F. Avoiding Opioids and Their Harmful Side Effects in the Postoperative Patient: Exogenous Opioids, Endogenous Endorphins, Wellness, Mood, and Their Relation to Postoperative Pain. Hawai'i journal of medicine & public health: a journal of Asia Pacific Medicine & Public Health. 2016 Mar; 75(3):63-7. 6.Mieszkowski M, Zawadzka E, Tuyakov B, et al. Evaluation of the effectiveness of the Quadratus Lumborum Block type I using ropivacaine in postoperative analgesia after a cesarean section - a controlled clinical study. Ginekologia Polska 2018; 89: 89-96. 7. Blanco R, Ansari T, Girgis E. Quadratus lumborum block for postoperative pain after cesarean section: a randomized controlled trial. Eur J Anesthesiol. 2015; 32: 812-8. 8. Blanco R, Ansari T, Riad W, et al. Quadratus Lumborum Block Versus Transversus Abdominis Plane Block for Postoperative Pain After Cesarean Delivery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016; 41: 757-62. 9. Singh R, Kumar N, Jain A, et al. Addition of clonidine to bupivacaine in transversus abdominis plane block prolongs postoperative analgesia after cesarean section. J Anesthesiol ClinPharmacol 2016; 32:501-4. 10. Sarvesh B, Shivaramu B, Sharma K, et al. Addition of Dexmedetomidine to Ropivacaine in Subcostal Transversus Abdominis Plane Block Potentiates Postoperative Analgesia among Laparoscopic Cholecystectomy Patients: A Prospective Randomized Controlled Trial. Anesth Essays Res. 2018; 12(4):809-813. 11.Kirksey M, Haskins S, Cheng J, et al. Local Anesthetic Peripheral Nerve Block Adjuvants for Prolongation of Analgesia: A Systematic Qualitative Review. PLoS One. 2015; 10(9). 12. Varshney A, Prabhu M, Periyadka B, et al. Transversus abdominis plane (TAP) block with levobupivacaine versus levobupivacaine with dexmedetomidine for postoperative analgesia following cesarean delivery. J Anesthesiol Clin Pharmacol. 2019; 35(2):161-164. 13- Qianchuang S, Shuyan L, Huiying u, et.al. Dexmedetomidine as an Adjuvant to Local Anesthetics in Transversus Abdominis Plane Block. A Systematic Review and Meta-analysis Clin J Pain. 2019 Apr; 35(4): 375-384. 14. Carline L, McLeod G, Lamb C. A cadaver study comparing spread of dye and nerve involvement after three different quadratus lumborum blocks. Br J Anesth. 2016; 117(3):387-394. 15. Kılıç E, Bulut E. Quadratus Lumborum Block III for Postoperative Pain AfterPercutaneous Nephrolithotomy. Turk J Anesthesiol Reanim. 2018; 46(4):272-275.

  BACKGROUND

MeSH Terms

Interventions

Bupivacaine; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Nesrine M. El-Refai, professor

  Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All participants, investigators, care providers and outcome assessors will be blinded to the study group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer of anesthesia,icuand pain management

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: February 10, 2021
• Study Start: February 2, 2020
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: July 26, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (2)