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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBaşakşehir Çam & Sakura City Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Procedure/Surgery

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

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

    Procedure/Surgery

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

Treatment groups

52 Participants
are divided into 2 treatment groups
Group A: Participants undergoing total hip arthroplasty with preoperative PENG blockActive comparator 1 intervention
Group B: Participants undergoing total hip arthroplasty with preoperative Lumbar ESP blockActive comparator 1 intervention

Trial outcomes

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").

Time frame
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

1

Effect on total narcotic analgesic consumption

After the surgery, patients will be given intravenous patient-controlled analgesia (PCA). "Tramadol" was preferred as the treatment method to be used for the PCA method. In preparation for PCA, 400 mg of tramadol is added to 100 cc of physiological saline. As PCA protocol, without basal infusion dose, 5 cc (20 mg) bolus dose, 20 minutes lockout period (maximum 3 bolus doses in 1 hour) are set. The total number of bolus doses administered by the participants on the PCA device at the end of 24 hours will be recorded and evaluated as the amount of additional opioid needed.

Time frame
The total number of bolus doses administered by the intravenous PCA device at the end of 24 hours postoperatively
2

Time, frequency, and amount of rescue analgesia administration

Pain scores (0-10; 0-3: mild pain, 4-6: moderate pain, 7-10: severe pain) will be questioned and noted with the Numerical Rating Scale (NRS). When the pain score is 4 and above, 20 mg tenoxicam will be administered as rescue analgesia and the total amount required will be recorded.

Time frame
first 24 hours postoperatively
3

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 blood pressure values will be noted.

Time frame
Pre-block, post-block, perioperative 0th and 30th minutes, 1st and 2nd hours, and end of surgery
4

Time of first mobilization

Time of first mobilization will be noted.

Time frame
first 24 hours postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.