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

Postoperative Pain Clinical Trial

Official title:

Effect of Preincisional Ultrasound-guided Quadratus Lumborum Block on Perioperative Analgesia and Inflammatory Responses in Transperitoneal Laparoscopic Nephrectomy: A Single-Blinded, Randomised Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03879980
• Other study ID #: IndonesiaUAnes031
• Status: Completed
• Phase: N/A
• Start date: March 18, 2019
• Est. completion date: June 17, 2019

Study information

• Verified date: July 2019
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Quadratus lumborum block had been studied as an effective postoperative analgesia in lower abdominal surgery, due to its spread to the thoracic paravertebral space and thoracolumbar fascia nerve. The effect of preincisional ultrasound (US)-guided QL block as "preemptive analgesia" on patient underwent laparoscopic living donor nephrectomy has never been evaluated. As preemptive analgesia, quadratus lumborum block could provide analgesics before and after surgery. Both groups immediately received basic postoperative analgesia regimen paracetamol 1 gr IV 8th hourly.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: June 17, 2019
• Est. primary completion date: May 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• BMI < 30 kg/m2

• ASA 1 or 2

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Bilateral QL block
Bilateral lateral Quadratus Lumborum block using 20 ml of 0.25% bupivacaine each injection as preemptive analgesia.
• Non-QL block
Only received fentanyl IV during surgery.

Locations

Country	Name	City	State
Indonesia	Rumah Sakit Cipto Mangunkusumo	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (14)

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. — View Citation

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):1141-61. doi: 10.1213/ANE.0b013e318277a270. Epub 2013 Feb 13. Review. — View Citation

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

de Oliveira CM, Sakata RK, Issy AM, Gerola LR, Salomão 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. Review. English, Portuguese, Spanish. — View Citation

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. — View Citation

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

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. — View Citation

Krohg A, Ullensvang K, Rosseland LA, Langesæter 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. Erratum in: Anesth Analg. 2019 Jan;128(1):e18. — View Citation

Méleine M, Rivat C, Laboureyras E, Cahana A, Richebé 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. — View Citation

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.

Richebé 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):969-70. doi: 10.1213/ANE.0b013e31828843c9. — View Citation

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. Review. — View Citation

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. Review. — View Citation

Warlé 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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Numerical Rating Scale	Pain measurement using Numerical Rating Scale (NRS) at rest and during movement. NRS from 0 =no pain to 10= worst pain at 2 hours and 24 hours after anaesthesia recovery	24 hours
Secondary	Hemodynamic Profiles: Heart Rate in bpm	The trends of perioperative haemodynamic profiles during and after surgery: heart rate in beat per minute	Intraoperative
Secondary	Hemodynamic Profiles: Systolic, Diastolic, and Mean Arterial Pressure in mmHg	The trends of perioperative haemodynamic profiles during and after surgery : systolic, diastolic and mean arterial pressure in mmHg	Intraoperative
Secondary	Number of participants with additional intravenous tramadol	During observation after surgery, when the NRS began to increase > 3 at rest the intermittent tramadol 50 mg IV boluses was given 8th hourly. If the NRS still remained > 3, the intermittent tramadol 50 mg IV boluses were administered more frequently up to 4th hourly.	24 hours
Secondary	Number of participants with additional intravenous fentanyl	If the pain relief was still inadequate after increasing tramadol boluses, the extra fentanyl 1 µg.kg^-1 IV boluses was given at every 15-30th minute until the NRS = 3.	24 hours