Comparison of Pain Relief Methods for Hip Surgery: A Study on Two Different Nerve Block Techniques

NCT06821516 | Recruiting

• 1 other identifier: BSH-ANES-BS-01
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized comparative study aims to compare the analgesic efficacy of pericapsular nerve group block (PENG) and lumbar erector spinae plane block (L-ESP) groups to relieve postoperative pain in participants over the age of 18 undergoing total hip arthroplasty under spinal anesthesia. The main question it aims to answer is: To demonstrate whether PENG block or L-ESP block is more effective in postoperative analgesia in patients undergoing total hip arthroplasty surgery based on pain scores, opioid consumption, and patient satisfaction. Total hip arthroplasties cause severe pain with movement in the postoperative period. After surgery, the movements of the participants are severely restricted, which increases the possibility of complications. In this study, the participants' pain status, VAS score, opioid consumption through patient-controlled analgesia, and patient satisfaction will be measured with a questionnaire for 24 hours at predetermined time points and then compared. Both types of blocks have pain-relieving effects. This study will only investigate which one is more effective in reducing pain, and there will be no deficiency in relieving the pain of the participants.

Conditions

Opioid Consumption, Postoperative; Pain, Postoperative; Nerve Block; PENG Block; Lumbar Erector Spinae Plane Block; Hip Replacement, Total; Postoperative Analgesia

Keywords

Pericapsular Nerve Group (PENG) Block; Lumbar Erector Spinae Plane Block; Total Hip Arthroplasty; Postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• Effectiveness on pain scores

  Postoperative pain assessment is performed using the Numerical Rating Scale (NRS). Participants are asked about their rest pain at Baseline 0, after the block, perioperative 15th minute, 1st hour, 2nd hour, and postoperative 1st, 3rd, 6th, 12th, and 24th hours after applying a postoperative peripheral nerve block. With this method, participants rate their pain with a precise numerical value from 0 to 10. While zero(0) represents "no pain"; Ten (10) represents the opposite end of the pain continuum (e.g., "The most intense pain imaginable," "As intense pain as possible," "Maximum pain").

  at Baseline 0, after the block, perioperative 15th minute, 1st hour, 2nd hour, and postoperative 1st, 3rd, 6th, 12th, and 24th hours after preoperative peripheral nerve block

Secondary Outcomes (6)

• Effect on total narcotic analgesic consumption

  The total number of bolus doses administered by the intravenous PCA device at the end of 24 hours postoperatively

• Time, frequency, and amount of rescue analgesia administration

  first 24 hours postoperatively

• Time-dependent perioperative changes in preoperative blood pressure

  Pre-block, post-block, perioperative 0th and 30th minutes, 1st and 2nd hours, and end of surgery

• Time of first mobilization

  first 24 hours postoperatively

• Length of hospital stay

  first 24 hours postoperatively

Study Arms (2)

Participants undergoing total hip arthroplasty with preoperative PENG block

ACTIVE COMPARATOR

Procedure: Evaluation of the postoperative analgesic effectiveness of PENG block in participants undergoing total hip arthroplasty under spinal anesthesia

Participants undergoing total hip arthroplasty with preoperative Lumbar ESP block

ACTIVE COMPARATOR

Procedure: Evaluation of the postoperative analgesic effectiveness of lumbar erector spinae block in participants undergoing total hip arthroplasty under spinal anesthesia

Interventions

Evaluation of the postoperative analgesic effectiveness of PENG block in participants undergoing total hip arthroplasty under spinal anesthesia PROCEDURE

Evaluation of the postoperative analgesic effectiveness of PENG block in participants undergoing total hip arthroplasty under spinal anesthesia

Participants undergoing total hip arthroplasty with preoperative PENG block

Evaluation of the postoperative analgesic effectiveness of lumbar erector spinae block in participants undergoing total hip arthroplasty under spinal anesthesia PROCEDURE

Evaluation of the postoperative analgesic effectiveness of lumbar erector spinae block in participants undergoing total hip arthroplasty under spinal anesthesia

Participants undergoing total hip arthroplasty with preoperative Lumbar ESP block

Eligibility Criteria

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

You may qualify if:

• Voluntary willingness to participate in the study.
• Patients who will undergo Total Hip Arthroplasty surgery.
• Patients aged over 18 years.
• ASA score I-II-III.
• Patients who are fully oriented and can cooperate.

You may not qualify if:

• ASA score IV-V.
• Patients who refuse to participate in the study.
• Patients under 18 years of age.
• Presence of active infection in the area to be operated on.
• Chronic pain and continuous analgesic use.
• Patients with coagulation disorders.
• Patients who cannot cooperate with postoperative pain follow-up.
• Patients with allergies to local anesthetic agents.
• Presence of neuropathy or myopathy in the operated extremity.

Sponsors & Collaborators

• Başakşehir Çam & Sakura City Hospital: lead

Study Sites (1)

Basaksehir Çam Ve Sakura City Hospital

Istanbul, Türki̇ye, Turkey (Türkiye)

RECRUITING

Related Publications (6)

• Pascarella G, Costa F, Del Buono R, Pulitano R, Strumia A, Piliego C, De Quattro E, Cataldo R, Agro FE, Carassiti M; collaborators. Impact of the pericapsular nerve group (PENG) block on postoperative analgesia and functional recovery following total hip arthroplasty: a randomised, observer-masked, controlled trial. Anaesthesia. 2021 Nov;76(11):1492-1498. doi: 10.1111/anae.15536. Epub 2021 Jul 1.

  PMID: 34196965 BACKGROUND

• Townsend D, Siddique N, Kimura A, Chein Y, Kamara E, Pope J, Weiser M, Nair S, Muse I. Lumbar Erector Spinae Plane Block for Total Hip Arthroplasty Comparing 24-Hour Opioid Requirements: A Randomized Controlled Study. Anesthesiol Res Pract. 2022 Oct 3;2022:9826638. doi: 10.1155/2022/9826638. eCollection 2022.

  PMID: 36225251 BACKGROUND

• Medhat MM, Kamel AAF, Salem DAE, Alagamy SA, Fathi HM. The Analgesic Effects of Preemptive Ultrasound-Guided Pericapsular Nerve Group Block in Comparison with Erector Spinae Plane Block in Elderly Undergoing Hip Arthroplasty: A Randomized Controlled Trial. Anesth Pain Med. 2023 Sep 4;13(5):e138623. doi: 10.5812/aapm-138623. eCollection 2023 Oct.

  PMID: 38028113 BACKGROUND

• Marrone F, Fusco P, Tulgar S, Paventi S, Tomei M, Fabbri F, Iacovazzi M, Pullano C. Combination of Pericapsular Nerve Group (PENG) and Sacral Erector Spinae Plane (S-ESP) Blocks for Hip Fracture Pain and Surgery: A Case Series. Cureus. 2024 Feb 7;16(2):e53815. doi: 10.7759/cureus.53815. eCollection 2024 Feb.

  PMID: 38332999 BACKGROUND

• Pai P, Amor D, Lai YH, Echevarria GC. Use and Clinical Relevancy of Pericapsular Nerve Block (PENG) in Total Hip Arthroplasty: A Systematic Review and Meta-analysis. Clin J Pain. 2024 May 1;40(5):320-332. doi: 10.1097/AJP.0000000000001196.

  PMID: 38268183 BACKGROUND

• Zheng J, Pan D, Zheng B, Ruan X. Preoperative pericapsular nerve group (PENG) block for total hip arthroplasty: a randomized, placebo-controlled trial. Reg Anesth Pain Med. 2022 Mar;47(3):155-160. doi: 10.1136/rapm-2021-103228. Epub 2021 Dec 6.

  PMID: 34873023 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Bites and Stings

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Central Study Contacts

MUZAFFER GENCER

CONTACT

+905059436459; aberkaysune@gmail.com

AZİZ BERKAY SÜNE

CONTACT

+905012413597; dr.m.gencer07@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor Doctor

Model Details: Patients who are admitted to the orthopedic and traumatology clinic and are scheduled for total hip arthroplasty surgery will be informed and monitored prior to the operation under spinal anesthesia. Preoperatively, either Pericapsular Nerve Group Block (PENG) (Group P) or Lumbar Erector Spina Plane Block (Group E) will be applied. Randomization will be performed using a computer-based method (http://www.randomizer.org) with a 1:1 allocation.

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 12, 2025
• Study Start: January 21, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)