Effect of Quadratus Lumborum Block on Perioperative Analgesia and Inflammatory Responses in Laparoscopic Nephrectomy

NCT03879980 | Completed

• 1 other identifier: IndonesiaUAnes031
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

Quadratus lumborum (QL) block can reduce intraoperative opioid consumption, decrease inflammation responses of IL-6, and reduce acute pain intensity in comparison with non-receiving QL block as the control group.

Conditions

Postoperative Pain

Keywords

quadratus lumborum block; pre-emptive analgesia; laparoscopic nephrectomy

Outcome Measures

Primary Outcomes (2)

• Intraoperative fentanyl consumption

  Intraoperative fentanyl consumption was recorded as total consumption in µg, and calculated into mean consumption per hour in µg.kg-1.h-1, due to the influence of patients body weight and duration of surgery to the given dose of fentanyl boluses.

  Intraoperative

• Changes in Interleukin-6 from baseline

  Measurement of plasma Interleukin-6 before the anaesthesia induction as the baseline; 2 hours of surgical stimulation and gas insufflation intraoperatively; and 2 hours after recovery from anaesthesia.

  24 hours

Secondary Outcomes (5)

• Numerical Rating Scale

  24 hours

• Hemodynamic Profiles: Heart Rate in bpm

  Intraoperative

• Hemodynamic Profiles: Systolic, Diastolic, and Mean Arterial Pressure in mmHg

  Intraoperative

• Number of participants with additional intravenous tramadol

  24 hours

• Number of participants with additional intravenous fentanyl

  24 hours

Study Arms (2)

Non-QL block

PLACEBO COMPARATOR

The control (non-QL block) group only received fentanyl IV during surgery.

Drug: Non-QL block

Bilateral QL block

EXPERIMENTAL

The patients were in the semi-lateral supine position to show up the side to be blocked. Using USG and 1-6 MHz convex transducer placed in the transverse plane above the iliac crest at the level of the umbilicus. A Stimuplex® 20G 100-mm needle was advanced in anteroposterior direction toward the junction of tapered abdominal muscle layer and QL muscle, and 20 ml of 0.25% bupivacaine was deposited in the anterolateral border of QL muscle at the junction with the transversalis fascia reach outside the anterior layer of transversalis fascia. The lateral approach QL (type I) blocks were performed at both sides of patients. The total amount of bupivacaine was 100 mg for each patient

Drug: Bilateral QL block

Interventions

Bilateral QL block DRUG

Bilateral lateral Quadratus Lumborum block using 20 ml of 0.25% bupivacaine each injection as preemptive analgesia.

Bilateral QL block

Non-QL block DRUG

Only received fentanyl IV during surgery.

Non-QL block

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI \< 30 kg/m2
• ASA 1 or 2

You may not qualify if:

• refused to participate
• chronic use of analgesics or anti-inflammatory drugs
• allergy to local anaesthetic
• duration of surgery \<4 or \> 6 hours
• duration of anaesthesia \<5 or \> 7 hours
• neuropathy

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Rumah Sakit Cipto Mangunkusumo

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

Related Publications (14)

• Hayden P, Cowman S. Anaesthesia for laparoscopic surgery. Continuing Education in Anaesthesia, Critical Care & Pain 2011;11(5):177-80.

  BACKGROUND

• Barreveld A, Witte J, Chahal H, Durieux ME, Strichartz G. Preventive analgesia by local anesthetics: the reduction of postoperative pain by peripheral nerve blocks and intravenous drugs. Anesth Analg. 2013 May;116(5):1141-1161. doi: 10.1213/ANE.0b013e318277a270. Epub 2013 Feb 13.

  PMID: 23408672 BACKGROUND

• Richebe P, Rivat C, Liu SS. Perioperative or postoperative nerve block for preventive analgesia: should we care about the timing of our regional anesthesia? Anesth Analg. 2013 May;116(5):969-970. doi: 10.1213/ANE.0b013e31828843c9. No abstract available.

  PMID: 23606468 BACKGROUND

• Meleine M, Rivat C, Laboureyras E, Cahana A, Richebe P. Sciatic nerve block fails in preventing the development of late stress-induced hyperalgesia when high-dose fentanyl is administered perioperatively in rats. Reg Anesth Pain Med. 2012 Jul-Aug;37(4):448-54. doi: 10.1097/AAP.0b013e318257a87a.

  PMID: 22660486 BACKGROUND

• de Oliveira CM, Sakata RK, Issy AM, Gerola LR, Salomao R. Cytokines and pain. Rev Bras Anestesiol. 2011 Mar-Apr;61(2):255-9, 260-5, 137-42. doi: 10.1016/S0034-7094(11)70029-0. English, Portuguese, Spanish.

  PMID: 21474032 BACKGROUND

• Vadivelu N, Mitra S, Schermer E, Kodumudi V, Kaye AD, Urman RD. Preventive analgesia for postoperative pain control: a broader concept. Local Reg Anesth. 2014 May 29;7:17-22. doi: 10.2147/LRA.S62160. eCollection 2014.

  PMID: 24872720 BACKGROUND

• Krohg A, Ullensvang K, Rosseland LA, Langesaeter E, Sauter AR. The Analgesic Effect of Ultrasound-Guided Quadratus Lumborum Block After Cesarean Delivery: A Randomized Clinical Trial. Anesth Analg. 2018 Feb;126(2):559-565. doi: 10.1213/ANE.0000000000002648.

  PMID: 29135590 BACKGROUND

• Ueshima H, Otake H, Lin JA. Ultrasound-Guided Quadratus Lumborum Block: An Updated Review of Anatomy and Techniques. Biomed Res Int. 2017;2017:2752876. doi: 10.1155/2017/2752876. Epub 2017 Jan 3.

  PMID: 28154824 BACKGROUND

• Warle MC, Berkers AW, Langenhuijsen JF, van der Jagt MF, Dooper PM, Kloke HJ, Pilzecker D, Renes SH, Wever KE, Hoitsma AJ, van der Vliet JA, D'Ancona FC. Low-pressure pneumoperitoneum during laparoscopic donor nephrectomy to optimize live donors' comfort. Clin Transplant. 2013 Jul-Aug;27(4):E478-83. doi: 10.1111/ctr.12143. Epub 2013 Jun 24.

  PMID: 23795745 BACKGROUND

• Agarwal A, Yadav G, Gupta D, Singh PK, Singh U. Evaluation of intra-operative tramadol for prevention of catheter-related bladder discomfort: a prospective, randomized, double-blind study. Br J Anaesth. 2008 Oct;101(4):506-10. doi: 10.1093/bja/aen217. Epub 2008 Jul 24.

  PMID: 18653496 BACKGROUND

• Moeller-Bertram T, Ky L, Coe C, Strigo I, Kincaid M, Keltner J, et al. Correlation of pain ratings and systemic interleukin-6 release in response to intramuscular capsaicin in healthy Humans. J Pain 2012;13(4):S52.

  BACKGROUND

• Blanco R. TAP block under ultrasound guidance: the description of a "no pops" technique [Abstract]. Reg Anesth Pain Med 2007;32:S1-S130.

  BACKGROUND

• Jianda X, Yuxing Q, Yi G, Hong Z, Libo P, Jianning Z. Impact of Preemptive Analgesia on inflammatory responses and Rehabilitation after Primary Total Knee Arthroplasty: A Controlled Clinical Study. Sci Rep. 2016 Aug 31;6:30354. doi: 10.1038/srep30354.

  PMID: 27578313 BACKGROUND

• Farouk S. Pre-incisional epidural magnesium provides pre-emptive and preventive analgesia in patients undergoing abdominal hysterectomy. Br J Anaesth. 2008 Nov;101(5):694-9. doi: 10.1093/bja/aen274. Epub 2008 Sep 26.

  PMID: 18820247 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Forty-four healthy patients with American Society of Anesthesiologists (ASA) classification I or II gave written consent to participate and were randomly allocated into QL block group or control (non-QL block) group. Randomisation used blocks of 4 into 2 groups using a list of random numbers and was performed by sealed envelopes. The surgeries were performed by 3 urology surgeon consultants with comparable distributions. Patients and principal investigator were blinded to group allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Head of Intensive Care Unit, Anesthesiologist Consultant

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 19, 2019
• Study Start: March 18, 2019
• Primary Completion: May 13, 2019
• Study Completion: June 17, 2019
• Last Updated: July 10, 2019

Record last verified: 2019-07

Locations

ID (1)