ITM + Bupivacaine QLB vs. ITM + Sham Saline QLB for Cesarean Delivery Pain

Phase 3

Terminated

Conditions: Pain, Postoperative

Interventions: Drug: ITM + Sham QLB
Drug: ITM + Bupivacaine QLB

Registration Number: NCT03261193

Lead Sponsor: Nicholas Schott

Brief Summary: Comparison of standard post-operative cesarean surgery pain management with regional post-op pain control.

Detailed Description: The purpose of this trial is to determine the efficacy of a postoperative analgesia strategy that incorporates quadratus lumborum block (QLB) in conjunction with a multi-modal post-cesarean analgesia strategy. The investigators hypothesize that QLB will provide superior post-cesarean analgesia compared to the current standard of care, multi-modal analgesia.

Thus, analgesia following cesarean section using QLB compared to the current standard of care alone will be further investigated. Current practice for cesarean surgical intervention consists of multi-modal analgesia (i.e., Intrathecal morphine (ITM) and scheduled post-operative non-opioid oral analgesics, with oral opioid analgesics reserved for breakthrough pain).

Investigators will measure side-effects associated with each strategy: Standard of care methods consisting of intrathecal morphine (ITM) plus scheduled non-opioid analgesics in conjunction with prn opioid analgesics for breakthrough pain will be utilized for both. The experimental treatment arm will entail standard of care in addition to QLB. The sham comparator will entail standard of care in addition to QLB with saline.

For each strategy, we will measure and model associated economic ramifications; such factors will include drug costs, procedure costs, and costs associated with length of stay and re-admissions.

The quadratus lumborum block (QLB) is similar to the transversus abdominis plane (TAP) block, but differs slightly in regards to the anatomical region where local anesthetic is injected. Since the quadratus lumborum (QL) is more posteriorly located, it theoretically confers greater safety due to enhanced visualization. The TAP block has been studied extensively for post-cesarean delivery pain, consistently showing that it is not superior to ITM for post-operative analgesia; however, it may prove to be helpful in patients with breakthrough pain despite the use of ITM, or in patients who were unable to receive ITM (e.g. general anesthesia for cesarean, contraindications to neuraxial morphine). Thus, ITM is superior to TAP alone for post-cesarean analgesia, but it is associated with a dose-dependent increased risk for opioid related side effects. In 2015, Blanco et. al. published a study specifically using the QLB for postoperative pain after cesarean delivery. In this study, they compared a true QLB to a sham QLB all in patients who did not receive ITM, and found that the QLB provided improved pain control and decreased the need for post-operative opioids. Another study in 2016 demonstrated that the QLB is superior to the TAP block in regards to decreasing post-operative pain following c-section. Unfortunately, neither study compared the QLB to ITM (part of the current gold standard for post-cesarean delivery pain, multimodal analgesia).

The gap in knowledge regarding the utility of QLB as part of a multimodal analgesic approach including ITM for cesarean section warrants further investigation. Clinicians are constantly searching for methods to provide patients with the most effective medical interventions that provide maximal benefit and minimal harm. Post-operative pain control following cesarean delivery is an area that is important to patients and to providers, and the introduction of the QLB for this purpose has the potential to improve analgesic benefit.

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 21

Inclusion Criteria

Elective cesarean planned under spinal anesthesia
Singleton pregnancy
American Society of Anesthesiologists (ASA) classification score of 2 (or less)
Gestational age of at least 37 weeks
Intention to breastfeed infant

Exclusion Criteria

Contraindications to neuraxial blockade (such as clinically relevant coagulopathy, recent anticoagulant use, patient refusal, or localized skin infection overlying the site of needle entry)
Anatomical abnormalities contraindicating spinal or QLB placement
Received/Conversion to general anesthesia
Received supplemental parenteral anesthesia (sedation) for any reason (e.g. unanticipated prolonged surgical procedure)
History of chronic pain
History of chronic opioid use/abuse
History of Subutex, methadone, other maintenance therapy

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ITM + Sham QLB	ITM + Sham QLB	Standard spinal with intrathecal morphine for surgical anesthetic with sham saline block. Saline will be administered as a quadratus lumborum block prior to cesarean section.
ITM + Bupivacaine QLB	ITM + Bupivacaine QLB	Standard spinal with intrathecal morphine for surgical anesthetic with ql block with bupivacaine local anesthetic. Interventional drug will be administered prior to cesarean section.

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS) Pain Score With Movement	24 hours after surgical procedure (cesarean delivery)	Post-operative pain accompanied with patient movement will be measured using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.

Secondary Outcome Measures

Name	Time	Method
Breast Feeding Success/Quality	24-hours post-operatively	Limited breastfeeding resulting from pain or opioid side effects
Visual Analogue Scale (VAS) Pain Score at Rest	48 hours after intervention	VAS pain score reported by the patient at rest post-operatively using a 10-point pain scale (VAS). The VAS scale is measured with 0=no pain at all and 10=most severe pain possible.
First Request for Pain Medication	From post-operative until the patient is either withdrawn from the study or requests analgesic medication up until 72 hours	Time to first opioid dose (measured in hours)
Sedation	24-hours post-operative	Presence or absence will be noted. Will be measured via Ramsay Sedation Score which ranges on a scale of 1 to 6 as follows: 1-patient is anxious, agitated, or restless. 2-patient is co-operative and oriented. 3-patient responds to commands only. 4-patient exhibits brisk response to light stimuli or loud auditory stimuli. 5-patient exhibits sluggish response to light or auditory stimuli. 6-patient exhibits no response.
Pruritis	48-hours post-operative	Presence or absence will be noted via standard pruritus scale (0-3). 0 being no evidence of pruritus, group 1 being pruritus on diseased skin, group 2 being pruritus on non-diseased skin, and group 3 being chronic reactive lesions acquired from skin manipulation, such as rubbing, picking, or scratching
Nausea/Vomiting	48-hours post-operative	Presence or absence will be noted via a scale of 0-3 as follows: 0-no nausea, 1-mild nausea not requesting pharmacological rescue, 2-moderate nausea requesting pharmacological rescue, and 3-severe nausea resistant to pharmacological treatment
Systolic Blood Pressure	48-hours post-operative	Will be measured in mmHG per standard of care and documented by study staff.
Respiratory Rate	48-hours post-operative	Will be measured in rate/min per standard of care and documented by study staff
Oxygen Saturation	4-hours post-operative	Will be measured in % per standard of care and documented by study staff
Heart Rate	48-hours post-operative	Standard heart rate obtained
Diastolic Blood Pressure	48-hours post-operative	Will be measured in mmHG per standard of care and documented by study staff.